LA City Council Votes Unanimously Against Corporate Personhood
Sandy Haksi, December 13, 2011
On December 6, 2011, Los Angeles became the first major US city to say that constitutional rights should be for actual flesh-and-blood human beings only, and not for the legally created fictions of corporate persons. Check out this inspiring footage from the vote!
By Dr. Mercola
Fluoride, a neurotoxin that has been linked to reduced IQ, impaired neurobehavioral development and brain damage, among many other serious health problems, is sometimes prescribed in supplement form to children ages 6 months to 16 years who live in areas that have non-fluoridated drinking water.
The rationale, which is heavily promoted by government agencies like the Centers for Disease Control and Prevention (CDC) – or rather its Oral Health Division
Bodies like the American Dental Association (ADA), is that this toxic agent helps reduce cavities – and those children who are “unfortunate” enough NOT to have the poison forced upon them in their drinking water should get their daily dose elsewhere (i.e. in supplement form).
These recommendations now defy rational logic and common sense on two fronts:
1) even promoters of fluoridation now admit that fluoride’s predominant action is on the surface of the tooth and not from inside the body (CDC, 1999) and
2) there are more than 100 published studiesillustrating fluoride’s harm to the brain, plus 25 published studies directly linking fluoride exposure to reduced IQ in children! In other words, it doesn’t do much (if any) good to swallow fluoride and doing so could be doing significant harm.
Adding insult to injury, new research has further revealed that ingesting fluoride in supplement form does not reduce cavities in primary teeth – and may in fact cause harm.
Richard Sauerheber, Ph.D.
(B.A. Biology, Ph.D. Chemistry, University of California, San Diego, La Jolla, CA)
Palomar College, 1140 W. Mission Rd., San Marcos,CA 92069
Email: richsauerheb@hotmail.com Phone: 760-744-2547
January 3, 2012
Dear U.S. Environmental Protection Agency,
I here raise a formal complaint against the Carlsbad Water District, San Diego County for its use of water with high arsenic levels, and for not reporting this clearly. A value of 120 ppb arsenic detected was listed on their water quality report 2011 with an average of 1.9 ppb. As you know, the EPA allowed MCL for arsenic since Jan., 2011 has been 10 – 50 ppb. The CA State MCL is 10 ppb and the State Public Health Goal is zero. A small amount of arsenic is diluted into water from added fluosilicic acid crude preparations that use the excuse of fighting cavities with the fluoride contained in it. Again, the arsenic PHG is zero.
Further, it is a violation of the Safe Drinking Water Act for any State to be less restrictive than its clause that prohibits any National requirement for any substance added into water other than to sanitize the water. This makes it illegal to add arsenic, fluoride, or any substance other than to kill bacteria, into water and yet the practice of adding both has now spread even here to Southern CA recently against the voting will of the public.
These were the typed data in the Carlsbad Water Quality Report, 2011. Arsenic: CA MCL 10 ppb; PHG .004; Sample 1.9 ppb; Range ND – 120 ppb.
I was told by an employee of CWD that the 120 number was not a reading, but an ‘allowed range’. But again the Fed and State allowed ranges do not include a number as high as 120 ppb. I told him that, and he said he wasn’t sure and that I need to talk with the suprvisor who is not available. The 120 number was printed in the report in the column in which measurements were reported, not in the column which lists the allowed MCL’s, as shown above.
If you could look into this we would appreciate it here in Carlsbad. We have had a terrible history with elementary school children perishing with cancers of various types and we are aware of the problem with schoolhouses being built on farms (as here) where arsenic pesticides had been used and that allowed arsenic emissions are detected from the Calrsbad emission stacks from a utility. The last thing Carlsbad children need is an extra dose of arsenic from their local water supply and yet that is what they are getting, from fluosilicic acid diluted waste and obviously additional unknown sources responsible for these readings. Carlsbad should be placed on a moratorium for the adidtion of crude hazardous diluted fluosilicic acid waste, out of sheer courtesy to the parents of these children as well as for the safety of the children themselves. I’ve had enough of fluosilicic acid waste that actually adds, for every 30 tons of added materials, 10 tons of sodium in fresh water where it does not belong, 10 tons of fluoride unwanted by the citizens, and 10 tons of silicic acid, all labeled as ‘water fluoridation.’ When does drugging the people of a city end, and who has the right to alter the bone density of citizens with fluoride that we now know crosses the blood brain barrier and injects arsenic when we are trying to remove it under our specific problematic circumstances here?
Thank you for your attention,
Richard Sauerheber, Ph.D.
WHAT OR WHO IS THE NATIONAL SANITATION FOUNDATION?
www.Fluoride-Class-Action.com/Sham
by James Robert Deal, President, Fluoride Class Action
January 3, 2011
This is the story of how an obscure trade association, formed in 1944 to make standards for restaurant sanitation chemicals, grew to the point where today it has agency-like authority to approve fluoridation materials and other chemicals as safe to drink.
I refer to the National Sanitation Foundation, more commonly known as “NSF”. The EPA delegated authority to NSF[1] to approve fluoridation materials[2] and other additives to drinking water. NSF says on its website:
In 1988, the U.S. Environmental Protection Agency (EPA) replaced its own drinking water additives program with NSF/ANSI Standards 60 and 61, which set public health standards for all chemicals used to treat water and products coming into contact with drinking water[3] ….
EPA sent in its experts to help NSF get up and running as a fluoridation approving agency. From the beginning EPA gave NSF money. EPA still gives NSF money[4].
The EPA had no authority to approve fluoridation nor to assign authority to NSF to approve fluoridation. Today the EPA has no authority to fund or encourage NSF to approve adding a drug – in this case a toxic one – to drinking water, but it continues to do so. EPA still reviews and approves NSF standards regarding fluoridation materials[5].
Sodium and Total Dissolved Solids Increase in MWD Water After Fluoridation
Richard Sauerheber, Ph.D. University of CA, San Diego; currently Palomar College, San Marcos
Lines are computed moving averages and increase progressively after 2007 when industrial sodium fluorosilicate injections began to treat tooth decay. Every ton of industrial waste fluosilicic acid requires 1/2 ton of sodium from sodium hydroxide Drano to maintain pH at 8.1 (two H+ ions from H2SiF6 requires two sodium ions).
Sodium at 116 ppm decreases crop yields and affects vegetable and fruit quality. Avocado production in Southern California is already down due to current sodium levels (North County Times, 2010). Sodium is released into the Colorado River by scores of industries lining the river. The EPA salt abatement program limits releases to one ton daily per site, but an exception has been made for Shell Oil at 2,000 tons salt daily at one facility.
Metropolitan Water District Los Angeles entered the industrial salt injection problem in 2007, with 0.1 tons daily sodium added at Lake Skinner alone, to neutralize fluosilicic acid to attempt to treat tooth decay that instead causes fluorosis. The EPA secondary standard for TDS (500 ppm) is exceeded but is not enforced–plants can tolerate natural TDS from 800-1000 ppm. No EPA standards have been developed by EPA for sodium since fresh water has historically been low in sodium. Sodium in blood is 3,000 ppm but is 0-10 ppm in pristine fresh drinking water. Vallecitos Water District raises no objections or questions to MWD on the injections and has ignored public testimony since 2006 opposing the ingestion of the non-FDA-approved fluoride water drug.
Click here to read full article.
See also:
When there is fluoride in river water at low levels, salmon swim the other way.
See these journal articles:
Salmon – repelled by fluoridation at only .25 ppm, Columbia River, Washington, Frasier River, Kamloops, British Columbia, summary of peer reviewed journal articles.
Salmon – Foulkes & Anderson, Impact of Artificial Fluoridation on Salmon Species in the Northwest USA and British Columbia, Canada, Fluoride, Vol 27, No 4, 220-226 (1994.)
The Fluoridation sham article has been revised and updated.
I have questions about the economics of fluoridation. http://fluoride-class-action.com/the-economics-of-fluoridation
If fluoridation stopped tomorrow, what would industry do with all the NaF and SiF it now sells to water district?
Is there another use for it? Is the price less for those other uses?
What would be the financial impact to the vendors?
What is the real economic effect of selling NaF and SiF as fluoridation materials?
Fluoridation materials represent what percentage of the chemical companies’ revenues and profits? What is the price the producers and resellers sell their souls for?
Has someone written on this subject?
***
Read this:
NSF tests fluoridation materials only rarely. On April 24, 2000, NSF responded to the State of Florida Department of Public Health[1] stated:
We have compiled test results for fluoride containing products that we bave tested and certified since 1992 (to 2000, an eight year period).There are 77 facilities that either produce or repackage fluoride containing treatment chemicals. . . These products (Hydrofluosilicic and Fluosilicic acid, Sodium Fluoride, and Sodium Silicofluoride) have been tested more than 100 times in our laboratories.
[1] http://fluoride-class-action.com/wp-content/uploads/nsf-hazan-letter-to-mendez-april-4-2000-nsf-fact-sheet-fluoride-2000-corrected-version1.pdf
Complete this paragraph:
Let’s do a little math, as Dr. Bill Osmunson suggests in his article on batch testing[1]. Assuming generously that the “more than 100 times” is 200 tests done over an eight year period, there would be an average of only 25 tests per year done nationwide. Given that there are 77 facilities, there would be an average of .32 tests per year done at each facility, or around one test every three years at each facility. Assuming that each of the 77 facilities ships 200 batch tanker loads per year, the likelihood of any one batch being tested would be .32/200 = .00162 = .162%. Thus the likelihood that any tanker load arriving at Seattle or Everett is tested is the inverse of .162%, that is around one in every 617.
Around 180,000 residents of the US drink fluoridated water. The cost of fluoridation materials is $_______ per ton for fluorosilicic acid.
The approximate amount of fluorosilicic acid required to fluoridate water per million people per year is ________ gallons or tons.
The amount spent yearly to purchase fluoridation materials is around $_____________.
(Sources needed, please.)
***
From Aliss:
Hi James,
The research I’ve done indicates that the silicofluorides can be stored indefinitely in huge gypsum stacks. These can be seen on the satellite maps. They don’t have to be turned into bricks and isolated (not like nuclear waste). But selling the stuff for fluoridation does seem to subsidize factory farming practices and cheap toxic food. However, no one gets overtly rich from this, really. Not farmers anyway. Cargill, and ADM and Dean Foods etc. – they get rich from controlling the food supply, and making some profit off the HFSA is one way they can undercut the price of sustainably grown food and control various futures and commodities prices.
I don’t think separating the silica is such a problem – they just add water and the stuff dissociates when it gets to a certain dilution and pH. If water fluoridation ended I honestly think there would be an economic stimulus to find a better way of handling the silicon tetrafluoride gas that is formed from the processing of the raw phosphate ore. But most of Florida’s easy phosphate mining is finished – the deposits are depleted – and there is mounting pressure to produce fertilizers without draining the porous limestone (causes sinkholes and is drying up the Everglades) or the use of natural gas, and that will certainly change the manufacturing process. There is also the inescapable fact that the so called “green revolution” using NPK chemical fertilizers has destroyed topsoil all over the planet on a massive scale, produced resistant weeds and pests, and agricultural yields have plummeted steadily. Supposedly it takes about five years to rehab the organic matter in the topsoil of an acre of chemically fertilized land. The world’s hungry can’t wait for that.
I have been part of a citizen movement to force the Canadian government to develop a national sustainable food production policy that includes preservation and improvement of agricultural lands and watershed protection. These asshole politicians seem to think we will always be able to buy food from the US so what’s the problem with not maintaining our own food production resources.
Aliss
***
From Bill:
Pesticides, teflon, medications, polish, lubricants, nuclear refinement, etc.
But they would have too much left over.
Bill
This comes from Aliss of Toronto:
If Public Health promoted smoking like they promote water fluoridation, here’s the letter we’d get back from our mayors and councillors:
Thank you for your email about our smoking policy.
I continue to consult regularly with the City’s Medical Officer of Health about this issue. Presently, the medical advice is to continue with smoking. The Board of Health voted recently to continue its support for smoking. We continue to monitor evidence supplied to us by the tobacco companies on the benefits of smoking.
Health Canada and the provincial health ministers agree that smoking is safe and beneficial, and is the most cost-effective and equitable way to reduce oxygen uptake from the lungs, especially in pregnant women, children, seniors and the poor. Second-hand smoke benefits non-smokers of all ages. That is why cities all across North America promote smoking.
Tobacco is a plant found growing naturally and is used by First Nations people. It is from a family that includes foods like spaghetti sauce. Smoking provides nicotine, tar, and trace mineral nutrients such as cadmium, lead and arsenic in optimal amounts.
Burning tobacco, like burning coal, also provides nutritious fluoride which hardens the arteries as well as the teeth. The industrial tobacco by-product used in municipal smoking must meet rigorous standards of purity and safety. The nutrients are regulated by provincial standards and are lower than levels from harmless volcanic emissions.
There is no credible scientific evidence that smoking is harmful when done at optimal levels. However, children under six should be supervised and taught not to inhale, as mild cosmetic brain damage may result.”
Here’s the actual email auto-response we are getting from our Mayor in Toronto no matter what is in the content of our letters, including Christmas greetings:
Thank you for your email about fluoride in Toronto’s drinking water.
I continue to consult regularly with the City’s Medical Officer of Health, Dr. David McKeown about this issue. Presently, the medical advice is to continue with fluoridation and the Toronto Board of Health voted last April to continue fluoridation of the City’s water. Fluoridation of water is the most cost-effective and equitable way to prevent dental decay for all residents, and that’s why cities across Canada and the United States continue to promote water fluoridation.
Fluoride is a naturally occurring mineral and is found in rocks, soil and water. The amount of fluoride added to drinking water is regulated by provincial standards. At the current level, Toronto’s drinking water contains a lower level of fluoride than naturally occurring levels in some parts of Ontario.
PREVENTING CAVITIES IN WAYS OTHER THAN USING FLUORIDE
12-6-11
More and more people are coming to the conclusion that we should not be drinking and eating fluoride.
Some still believe that applying fluoride topically is the best way to prevent tooth decay. I disagree. I say we should avoid all fluoride.
We are not doing anything to instruct people about the other things they could be doing for their teeth. To get them to stop fluoridating and using fluoridated toothpaste, we ought to tell them what else they could do for their teeth that would be better than fluoride.
So I asked what we should be telling them:
Don’t eat sugar, bread, pasta, candy, cake, sugary cereals
Brush after meals with non-fluoridated toothpaste
Use tiny tooth brushes for cleaning between teeth
Take calcium and magnesium supplements?
Eat less animal products – which acidifies blood and sucks calcium out of bones?
Chewing xylitol gum?
Antibacterial therapy—such as treatment with chlorhexidine gluconate rinse, mentioned by Featherstone
http://washingtonsafewater.com/wp-content/uploads/science-and-practice-of-caries-prevention-john-featherstone-JADA-july-2000.pdf
But let’s not join any fad such as Atkinson or Weston Price. Weston has his critics:
http://www.whattoserveagoddess.com/weston-price-foundation
http://www.vegsource.com/articles2/fuhrman_dietary_myths.htm
Weston was right on several points. About processed foods – white flour, phosphate rising powders, cereal, sugar, jam, corn syrup, vegetable oils and canned milk. About eating grains. We did not evolve to eat unsprouted grains.
And he was half way right about raw milk. It is better than commercial milk. But it is still for calves. There is calcium in the milk but it is calcium phosphate. We do not need more phosphate. Cow milk has no magnesium, no potassium, no iron, and no essential fatty acids. It is a totally different composition than mother’s milk. Nature leaves those things out of cow’s milk because they are found in the grass which calves start eating shortly after birth. And milk has too much protein. Too much protein is just as much a problem as too little. Most get far too much protein.
Raw milk is better than commercial milk, and people should have the right to produce and buy and sell it. But in this era of tenacious microbes, I suggest you boil it first, as do the Indians. Better yet, avoid it too. It uses up your caloric allotment and gives you none of the nutrients you need along with too much protein.
When it comes to a meat centered diet, there is a problem with returning to an originalist Weston Price diet: The food is not available. You will not find lean, healthy organic meat in any significant quantity at a price that most people can afford. The bad money drives out the good, and the cheap meat drives out the expensive. Even hunted meat can be polluted because wild animals can go everywhere and eat grains treated with pesticide. Wild animals can be infected with the wasting “mad cow” diseases. Hunted meat is very expensive when you factor in the cost of guns, licenses, travel, and clothing. Weston says to eat organs, but we know that the body stores things it cannot excrete in the organs.
The meat that the aborigines of Borneo ate with Weston is not available today.
Commercial animals are fed phosphate fertilizer, and so their meat contains more FLUORIDE. Commercial chickens are fed ARSENIC.
Fish has DHA and vitamin D. Unfortunately we treat the oceans both as our grocery store and our sewer. We have polluted our salmon and tuna with mercury and our filter feeders with PCBs.
We have over populated the planet and we no longer have the right to eat “high on the hog”.
Weston was right on another point: If you want to eat meat, eat insects, as low on the food chain as possible.
Any grains should be sprouted to get rid of the phitates in the hulls. That’s the problem with bread made from flour.
The key to healthy teeth is eating a lot of fruits, nuts, and vegetables, rich in minerals, and avoiding processed foods, including as you said white flour, phosphate rising powders, cereal, sugar, jam, corn syrup, vegetable oils and canned milk.
And if you have to eat meat, it should be an occasional condiment not the main course three times a day. We eat a lot more meat now than we did before refrigeration. A large part of the diet of Australian aborigines and African bushmen is vegetables.
Too much meat and milk and eggs acidifies blood and requires that calcium be pulled out of bones. Blood pH cannot vary much.
Plant a garden and grow your own
http://www.whattoserveagoddess.com/wp-content/uploads/red-leaf-lettuce1.jpg
http://www.whattoserveagoddess.com/chapter-18/
During the winter or if you live in an apartment, sprout lentils, mung, spelt, wheat, beans.
The problems with an all vegetable diet are:
No DHA, which some cannot manufacture out of flax if they are sickly.
No B-12, which must be supplemented with nutritional yeast.
No vitamin D, and there is not enough sun in Seattle. Take D-2 supplements and take twice as much.
If you want to go Weston, raise chickens in your backyard and eat their eggs and the roosters. And eat that aphid encrusted kale in the Spring. That’s the closest you can come in an environmentally responsible way.
I have been a strict vegan for 30 years. Note that I am not dead yet, as Weston would imply I should be.
However, I do not expect others to be so extreme. I do the vegan thing for religious and environmental reasons.
But I have figured out that the world is not going to switch to veganism any time soon.
Veganism is not the solution for everyone. Nor is the Weston Price diet.
***
I renew another question:
Is it possible that the explanation for the drop in tooth decay generally is that occasionally children and adults are administered rounds of antibiotics to fight colds? Would general antibiotics also kills tooth decay germs such as mutans streptococci and lactobacilli?
Does the drop in tooth decay correlate inversely with the rise in use of antibiotics?
Sincerely,
James Robert Deal , Attorney
James@JamesRobertDeal.com
***
My original question:
12-5-11
Questions to ponder:
People will ask, well if fluoride is not good for teeth, what is good for teeth?
Not eating sugar, bread, pasta, and what else?
Is the sugar in fruit bad for teeth?
Using floss?
Calcium and magnesium supplements?
Tiny tooth brushes for cleaning between teeth
Flossing
Brushing after eating with non-fluoridated toothpaste
Eating more vegetables – rich in calcium
Eating less animal products which acidifies blood and sucks calcium out of bones?
Chewing xylitol gum?
Antibiotic mouthwash (referred to by Featherstone)?
Hypothesis: Is it possible that the explanation for the drop in tooth decay generally is that occasionally children and adults are administered rounds of antibiotics to fight a cold? Which also kills tooth decay germs?
Does the drop in tooth decay mirror the rise of antibiotics?
Sincerely,
James Robert Deal , Attorney
James@JamesRobertDeal.com
From Aliss:
Hi James,
Dr. Weston A. Price was a dentist and root canal specialist in Cleveland in the 1930s and wondered many of the same things. Like many of his time and today, he thought vegetarian diet with lots of fibre from whole grains was the healthiest diet for humans. He really wanted this to be proven. But more than a dentist, he was one of those lateral thinkers with a truly scientific mind. Dentistry as a profession was changing from extractions towards prevention, hygiene, and preserving decayed teeth with fillings, root canals and crowns. He was concerned about the increase in numbers of child patients with worse decay than ever. In fact his own child died from infection after a root canal on a decayed tooth. This devastated him of course. It made him rethink whether dentistry should be focused on saving teeth with technofixes. He thought rotten teeth might be caused by the civilized diet – especially white flour, phosphate rising powders, cereal, sugar, jam, corn syrup, vegetable oils and canned milk. Note that many of these processed foods are quite high in fluoride. Phosphate baking powders in particular supply both aluminum and fluoride.
So on his yearly vacations, he decided to search the world for so called primitive cultures not exposed to these foods and examine their diet and health. He took meticulous notes, sent food samples back to his lab for analysis of nutrients, did dental exams, and took thousands of photos. His tome is called Nutrition and Physical Degeneration and is available from the Price Pottenger Foundation of California. It has been reprinted numerous times. He was first enamoured of fluoride due to the propaganda of the time, and then disillusioned when his scientific data certainly did not match any of the claims.
Price was surprised to learn that diets rich in animal fats and proteins, especially organ meats such as liver, and animal source minerals especially bone and gelatine broths, sea food and milk products, with the lowest intake of agricultural grains and legumes produced the healthiest peoples with the best teeth and bones, from the Arctic to the southern Kalahari. No vegans. None of these people cleaned their teeth but they had beautiful, white, strong enamel and 32 teeth in perfect alignment in broad jaws. Except for the Swiss village where some of the kids had green slime on their teeth but no cavities or gum disease (must have been chlorophyll producing probiotic strains!) Healthy cultures that included grains and legumes had elaborate methods of soaking, fermentation and phytate removal before eating, and these foods were cooked with meat, bones, lard or fish or served with eggs or insect larvae rich in fats. Cultures that depended mostly on grains had poor dental health, smaller stature and weak bones. But wherever a settlement had been exposed to modern processed foods that displaced the local traditional foods, there was an immediate decline in the physical health and appearance of the children born after that time, with malformed faces, decayed teeth, rickets and TB. It was quite dramatic.
One of the few fluoridation studies that controlled for some nutrition variables was done right here in the Toronto area by Dick Ito who is now one of the most aggressive pro-fluoridation public health politicians (not elected and not accountable to us, of course). It showed that the most significant factor in childhood dental decay in Brampton (fluoridated) vs. Caledon (not) was whether the kid was taking a daily multi vitamin-mineral supplement. Ito’s conclusion says fluoridation benefit was not evident at all but dental fluorosis was higher in Brampton. Duh. Ito pretends not to hear you when you question him about this previous research. I am sure he would remove his name from the study if he could, given his political stature now, but it’s on PubMed.
Aliss
If your tap gushes water laced with fluoride, you’re taking a powerful drug with every sip.
Imagine a stranger pressing you to drink a clear liquid with no special odor, color, or taste. “Just drink, it’s good for you,” he insists. What would you do? Refuse it, probably. And if the stranger were to become overbearing, you’d want to bat it away. At least, you’d want to know what’s in that water and what it might do to you. But do you know what’s in your own tap water?
One of the things in your water is fluoride. It’s supposed to be good for your teeth. In the US, Israel, and other countries in the Middle East the law requires that fluoride be added to the water supply. So it must be OK – go ahead and drink. Considering the scarcity of water in the Middle East, just be grateful. You might hesitate, though, if you knew that the comforting fluoride in your glass of water is used as rat poison. In this story I interview someone who has worked for a national water carrier. What she says might shock you.
It’s no secret where fluorides come from. They are the direct, unprocessed wastes of fertilizer, nuclear, aluminum, steel, and pesticide industries. Once hailed as a cheap way to rescue the population from tooth decay, it is proven to be a powerful toxin that causes, and aggravates, a long roster of ills.
According to studies provided by the Fluoride Action Network (FAN), cancer, arthritis, thyroid dysfunction, and neurological disorders are related to fluoride intake. Brittle bones. Calcification of the pineal gland.
We interviewed Prof. Loty Zilberman, occupational health and toxicology consultant and former water engineer for Mekorot, the Israel water company, to learn more.
GP: How toxic is fluoride?
Prof. Zilberman: It’s so corrosive that storage facilities have bunkers built around them for safety. Workers must wear full body protection.
Fluorides draw copper out of plumbing pipes, so our water contains copper. Boys and young men are at special risk of asthma and neurological dysfunction, leading to violent behavior, from excess copper absorption. The synergy of fluorides with other waste products in our water produces a most powerful toxin that increases risk of Alzheimer’s and and osteosarcoma (a type of cancer), again, especially in boys. Fluorides neutralize iodine, so that thyroid patients taking iodine medication suffer.
Excessive fluoride causes fluorosis – white streaks on children’s teeth. So what is it doing to the rest of their bones? Children are most at risk from the toxic effects of fluoride, absorbing three times as much as adults do. Bottle-fed babies inevitably drink fluoride in their formula.
We see the effects of excess fluoride in the rocketing levels of cancer and arthritis in today’s children and young adults.
GP: And this rat-poison business…? What’s that all about?
Prof. Zilberman: Fluoride, being a protoplasmic toxin, is used as rat poison.
GP: Quite a little shop of horrors! What are safe levels of fluoride in water?
Prof. Zilberman: In Israel, no studies have been conducted to determine safe levels. In the US, fluoridation laws were passed before any studies were done.
GP: Is fluoride in all water?
Prof. Zilberman: Any water that comes out of a tap in Israel has fluoride. We’re talking about the water used for agriculture and food and drink industries. The water with which you wash laundry, shower, and brush your teeth. You absorb the fluoride in water through the skin, so that every time you wash your hands, you get another tiny dose of it.
GP: Can’t we just boil it out of our drinking water? What about filtering it?
Prof. Zilberman: Boiling water only concentrates the fluorides in it. Popular household filters don’t affect it. The only way to eliminate fluoride from water is by reverse osmosis, a costly setup. So people without financial means have no choice but to keep absorbing fluorides.
Medicine should not be given out indiscriminately to an entire population. Fluoride is a medicine that dentists should prescribe when necessary, and monitor just as any other doctor monitors a patient taking a prescription drug.
GP: Why do fluorides get dumped into our water, anyway? And why do our governments still sing the “It’s Good For You” song?
Prof. Zilberman: I can answer only for Israel. It’s cheaper than burying it. It can cost thousands of shekels per cubic meter to remove waste. The Koor factory in Acre, for example, may have 15 cubic meters of waste daily.
Industries have a financial interest in maintaining fluoridation. The government apparently still holds by the outdated idea that it prevents dental cavities. Perhaps there’s also the fear that, as happened in the US, once the toxic effects of fluoride are understood, people will start suing industries for damages.
GP: Thank you, Professor Zilberman!
11-25-11
Happy Thanksgiving to All:
I like Wikipedia. I use it daily. I just donated $10 to Wikipedia. I also criticized Wikipedia:
I am the president of www.fluoride-class-action.com and the vice-president of www.washingtonsafewater.com.
I am an attorney:
www.mortgage-modification-attorney.com.
And I am a published author: www.whattoserveagoddess.com.
I use Wikipedia daily.
My only criticism is that your page on “fluoridation” is one-sided and at times grossly inaccurate.
Example:
“Although water fluoridation can cause dental fluorosis, which can alter the appearance of developing teeth, most of this is mild and usually not considered to be of aesthetic or public-health concern. There is no clear evidence of other adverse effects.
Both statements are false. See: http://fluoride-class-action.com/occupy-seattle-flier-10-21-11
There is a Fluoridation Controversy page at http://en.wikipedia.org/wiki/Water_fluoridation_controversy. It is equally lacking in objectivity.
When our scientific experts post anything critical of fluoridation, their comments are immediately deleted. On this subject Wikipedia is clearly lacking in objectivity. On this subject the site is clearly controlled by the chemical company profiteers who sell fluoride and their misinformed dental and medical supporters.
James@JamesRobertDeal.com
Send your feedback to Wikipedia. We should demand that Wikipedia be more objective.
Go here to give feedback: https://meta.wikimedia.org/wiki/Foundation_wiki_feedback
James
A 23% fluosilicic acid solution, because of the chemistry of aqueous fluorides, typically contains around 1.5 % HF (as assayed by Lucier Chemicals for Metropolitan Water, Los Angeles).
This is 23 grams of H2SiF6 and 1.5 grams of HF per 100 grams of solution, which is 18 grams of fluoride from H2SiF6 and 1.5 grams of fluoride from HF.
Thus, 8% of all fluoride present in the solution is HF.
The Code of Federal Regulations specifically and explicitly prohibits the marketing, interstate transport, or ingestion of any anti-caries agent that contains HF without a new drug application – NDA.
Fluosilicic acid hazardous waste preparations are currently diluted into nearly 70% of all U.S. water supplies without FDA approval and without a prescription. A 1.0 ppm fluoridation level produces 0.21 ppm anionic fluorine in human blood, and such action requires an FDA ban, or an approved NDA.
***
Here also is the calculated HF concentration that would be present in the stomach if one were thirsty and filled up from drinking 1 ppm fluoride water. That is:
HF produces H+ and F- as a weak acid with dissociation constant Ka = 7.2 x 10-4 (CRC Handbook for Chemistry and Physics)
So 7.2 x 10-4 = [H+][F-]/[HF] where [F-], after combining with stomach acid H+, = 5.2 x 10-5M – X (1 ppm in molarity units minus the unknown molarity X for HF)
Rearranging, 7.2 x 10-4X = [10-3][5.2 x 10-5 - X] and 0.00172X = 5.26 x 10-8
Solving, X = 3 x 10-5 M HF in stomach acid, which is 0.6 ppm HF.
This agrees with experimental observations with a fluoride ion specific electrode at pH 3, where 1 ppm fluoride water is detected as only approximately 0.5 ppm. This level of HF is a significant concentration of this uncharged tissue-penetrating corrosive in contact with stomach mucosal tissue.
I will be calling this to the attention of the FDA.
I calculated the concentration of HF that would be present in a solution that is buffered to pH 7 with 1 ppm total fluoride and it is about 0.14 ppb of this corrosive substance HF. This would be unimpressive to those promoting fluoride to be concerned about, but nevertheless it is the most corrosive substance known and is the active ingredient in industrial uses on glass, ceramics, computer chips, etc. when conditions are not buffered. In plain water without buffering, the HF is higher.
Richard Sauerheber, Ph.D.
(B.A. Biology, Ph.D. Chemistry, University of California, San Diego)
Palomar College, San Marcos, CA
richsauerheb@hotmail.com Phone: 760-744-1150 xt 2448
Republicans just won’t give up on their misguided attempts to subvert the Clean Water Act. Senators John Barrasso of Wyoming and Dean Heller of Nevada plan to offer a rider denying protections to one-fifth of the nation’s wetlands and as many as two million miles of small streams. The House has approved a similarly destructive measure, so it is crucial that the Senate majority leader, Harry Reid, and his Democratic colleagues block this legislation.
The 1972 act was designed to protect “all the waters of the United States.” It required any commercial developer who wanted to dredge or fill a water body to obtain a federal permit; the purpose was to prevent destructive projects and mitigate the damage of those allowed to proceed. Over the years, muddled Supreme Court decisions, plus directives from the George W. Bush administration, created great uncertainty about which waters were regulated. The result was to limit protections to navigable waterways while removing them from small streams and wetlands that are no less critical to the health of the nation’s drinking water and aquatic ecosystems.
In April, the Obama administration proposed new guidelines restoring inclusive protections and promised to codify them in permanent regulations. This infuriated home builders and anyone else with an interest in filling in streams and wetlands. The House then voted to prohibit the Environmental Protection Agency and the Army Corps of Engineers from carrying out the new guidance. The Senate bill would permanently prevent action to clarify the law. As always, the legislators driving these campaigns say their goal is to remove regulatory barriers to job creation. But the real issue is whether the country gets the clean water it wants and needs.
Reporting from Washington — The Environmental Protection Agency said it planned to regulate wastewater discharged by companies producing natural gas from shale formations, including chemically laced water used in a controversial extraction process known as hydraulic fracturing.
The EPA’s initiative comes as water-intensive natural gas production has spread around the country, raising concerns about the effects on drinking-water supplies. The practice, also known as fracking, involves shooting water infused with chemicals and sand at high pressure into shale formations to unlock reservoirs of natural gas.
The EPA will try to determine what to do with water used during fracking, as well as water that is already underground and flows back up the well. Companies now often release the water from the production process into municipal wastewater systems. Those treatment facilities lack the technology to completely remove the chemicals, salt and minerals in the wastewater before sending it into streams and other surface water, said Ben Grumbles, president of Clean Water America Alliance, an association of municipal water districts and private industry.
Barraged with accusations from some congressional Republicans that EPA regulations kill jobs, the agency was careful to say that the new rules were not meant to crimp natural gas production.
“The president has made clear that natural gas has a central role to play in our energy economy,” said EPA Administrator Lisa P. Jackson. “We can protect the health of American families and communities at the same time we ensure access to all of the important resources that make up our energy economy.”
Barry Russell, president of the Independent Petroleum Assn. of America, a trade group, cautiously welcomed the EPA’s plans. “The new guidelines EPA develops will then be used by states to regulate specific wastewater discharges,” he said in an email. “We stand ready to work with EPA and other stakeholders on the development of these guidelines.”
Environmentalists also backed Thursday’s announcement. The environmental law group Earthjustice said in a statement: “The nation is in the midst of a fracking-fueled gas rush which is generating toxic wastewater faster than treatment plants can handle it. The EPA’s proposal is a common-sense solution for this growing public health problem and will help keep poisons out of our rivers, streams, and drinking water.”
The EPA said it would propose rules for wastewater from shale gas production in 2014; it expected to propose similar rules for wastewater from coal-bed methane production in 2013.
On behalf of 63 environmental groups, Earthjustice sent the EPA a letter in early 2010 urging it to expand a study of wastewater from coal-bed methane production to also include water associated with shale gas production.
Shale gas production accounts for 15% of U.S. natural gas output, after beginning at “negligible” levels a few years ago, the EPA said in its statement. While the shale gas boom has created jobs, it has also had an impact on water that is not yet fully understood, the EPA said.
As wastewater from shale gas and coal-bed methane production is regulated, companies will probably have to process and reuse the water, injecting it again into the well to nudge the gas out, Grumbles said.
Once the water can no longer be used, it could potentially be injected into regulated, deep underground storage wells. This year, the state of Pennsylvania, home to a shale gas boom, mandated that companies recycle their wastewater rather than send it through municipal treatment plants, Grumbles said.
http://articles.latimes.com/2011/oct/21/nation/la-na-frack-water-20111021
From: James Robert Deal <JamesRobertDeal@jamesdeal.com>
5th Nov. 2011
Assistance needed.
I am busy working on a FOIA request to send to Everett and Seattle.
You can help by going to relevant Facebook walls and other blogs and Twitters and posting this message:
A small amount of a known poison added to our drinking water is not okay.
http://washingtonsafewater.com/press-release/press-release-for-candidates/
Here is another one you can post:
The people who are selling you lead-arsenic-silicofluoride toxic waste industrial grade poison to put in your water – are the same ones who sold your grandparents tetraethyl lead.
http://fluoride-class-action.com/speeches/tetraethyl-lead
Here’s another one:
Silicofluoride – not FDA approved. Not approved by EPA. Not approved by any federal or state agency. Approved only by a sham FDA known as NSF, a trade association which takes money and direction from the EPA. The big chemical companies that produce the silicofluoride can sit on influential boards.
http://fluoride-class-action.com/sham
Post it on the Occupy Facebook sites.
Thanks for the help.
I also need people who will search the candidates page of the county web site and “harvest” the email addresses of all candidates for every office from top to bottom. I’ll put them on my mailing list.
How about Pierce County Washington? How about Los Angeles County? San Diego County? City of New York.
Doing this is not a violation of CAN-SPAM. That law exempts political messages where you are not trying to sell anything, especially where candidates have posted their email addresses. A posting like this constitutes consent. Nevertheless, if you want to be removed from receiving emails from us, just reply and tell us.
Sincerely,
James Robert Deal , Attorney
James@JamesRobertDeal.com
JAMES ROBERT DEAL ATTORNEY PLLC
PO Box 2276, Lynnwood, Washington 98036-2276
Telephone 425-771-1110, Fax 425-776-8081
James@JamesRobertDeal.com
PRESS RELEASE:
WASHINGTON ACTION FOR SAFE WATER
TO OCCUPY SEATTLE MUNICIPAL BUILDING MONDAY AT NOON
SEATTLE WATER IS NOT SAFE TO DRINK
DUE TO LEAD, ARSENIC, SILICOFLUORIDES ADDED
October 31, 2011
Summary:
On Monday at noon, members of Washington Action for Safe Water will occupy the foyer of the Seattle Municipal Building to deliver this press release, hand out our fliers, and as a group deliver them to the mayor, city council members, and city attorney. Bill Osmunson, Bellevue Dentist, and president of WASW, says: “Seattle adds the cheap, commercial, toxic waste version of fluoride to our water, known as silicofluoride. It is not FDA approved. It is not pharmaceutical grade. It contains lead and arsenic. And it leaches lead from pipes.”
***
Bill Osmunson, Bellevue Dentist, and president of WASW, says: “Seattle adds the cheap, commercial, toxic waste version of fluoride to our water, known as silicofluoride. It is not FDA approved. It is not pharmaceutical grade. It contains lead and arsenic, and it leaches lead from pipes.
On Monday at noon, members of WASW and other safe water groups will occupy the foyer of the Seattle Municipal Building to deliver this press release, hand out fliers, and as a group deliver them to the mayor, city council members, and city attorney.
Osmunson says, “Washington Action for Safe Water is demanding a written response and demanding that this issue be put the issue on the Seattle City Council agenda. All candidates for office are being asked if they will put this issue on the agenda and give it a fair hearing.”
http://fluoride-class-action.com/questionaire-to-candidates
According to James Robert Deal, Lynnwood attorney and vice-president of WASW, “In 2004 we learned that tap water in old Seattle schools contained lead at up to 1.6 parts per million, an extremently high level, higher than the fluoride level. Old schools contain brass pipes and fittings which can be from 8% to 30% lead. Much money has been spent replacing pipes, but the lead leaching problem in Seattle schools has not been solved. Ending fluoridation would stop most lead leaching and stop the dumbing down of our children.”
http://fluoride-class-action.com/hhs/comments-re-lead
According to Deal, “Silicofluoride also contains arsenic, a confirmed Type 1, Class A human carcinogen. There is no acceptable level of arsenic which may be added to drinking water.”
According to Ossmunson, who also has a degree in public health, “The CDC admits that 41% of children age 12-15 suffer from some degree of dental fluorosis, that 8.6% suffer from mild fluorosis (white spots and some brown spots with up to 50% of tooth surfaces affected), and that 3.6% suffer from moderate and severe fluorosis (white spots and brown spots and sometimes pitting and chalky teeth, with up to 100% of tooth surfaces affected).”
Ossmunson says, “The CDC also admits that the effect of fluoride is topicial only. It makes as much sense to drink fluoride as it would to eat sunscreen.”
Ossmunson continues, “The CDC, ADA, and many other groups advise that infants should not drink fluoridated water nor consume formula made up with fluoridated water. Their kidneys are not developed, and they have trouble excreting it.”
Ossmunson says, “If fluoride is in tap water, it is all food and beverages made with tap water – cola, coffee, beer, reconstituted juices, bread, cereal, canned vegetables, rice, and restaurant food.”
Deal says, “The silicofluoride we drink is cumulative. The body has trouble eliminating it and stores half in bones and other organs. Silicofluoride builds up over a lifetime and causes or worsens hip fractures, arthritis, kidney disease, thyroid disease, and many other maladies.”
Deal says, “The effect of silicofluoride on Hispanics, Blacks, and the poor is greatest. Alveda King, Bernice King, and Andrew Young are leaders in the Fluoride-Gate movement. They see fluoride as the next civil rights issue.”
***
We will occupy the center of the Municipal Building foyer with our Washington Safe Water sign, which says “Tap Water – Not Safe To Drink – WashingtonSafeWater.com.
Send a news crew to the municipal building at Noon on Monday, October 31 for this press release. I will be there beginning at 11:00 for interviews. My phone number is 425-774-6611.
For comments call:
James Robert Deal, Attorney WSBA Number 8103 James@JamesRobertDeal.com 425-774-6611Bill Osmunson, DDS, MPH Bill@TeachingSmiles.com 425-466-0100
PROFITABLE FRAUD BY MEGA CHEMICAL COMPANIES ADDS
LEAD, ARSENIC, SILICOFLUORIDE TO DRINKING WATER
Notice of Liability Served on Seattle and Everett
Suit Filed in Federal Court in San Diego
Suit Filed in Federal Court in Maryland
Access links online at: http:/Fluoride-Class-Action.com/occupy-seattle-flier-10-21-11
WHAT YOU CAN DO. Write or email the Seattle City Council or the Everett City Council or the council of whatever city, county, or water district you are in. Demand that they put the fluoride issue on the agenda and put a moratorium on fluoridation. Demand that we receive clean unpolluted water, containing zero lead, zero arsenic, and zero silicofluoride.
BAIT AND SWITCH. Seattle, Everett, and most US cities that fluoridate, do so with silicofluoride (SiF); around 8% use sodium fluoride (NaF). SiF and NaF are much more toxic than naturally occurring calcium fluoride (CaF). CaF can be fairly pure, depending on its source. NaF is industrial grade but relatively pure; SiF is industrial grade toxic waste, highly contaminated with heavy metals.
SiF CONTAINS LEAD. The EPA maximum contaminant level (MCL) for lead is 15 ppb, and the maximum contaminant level goal (MCLG) is zero. Lead permeates all cells in the body, reduces IQ, and causes kidney disease and high blood pressure.
LEAD IN SCHOOL DRINKING WATER. In 2004 Seattle papers reported lead at up to 1,600 ppb (1.6 ppm, a very high level) found in drinking water in old Seattle schools. SiF, more so than sodium fluoride, leaches lead from pipes and faucets.
New brass pipes and faucets contain around 8% lead and older pipes contain as much as 30% lead. Most old schools, old homes, old apartment buildings, old hospitals, old office buildings, and old factories contain pipes with high lead content, which SiF will leach out. If water districts stopped fluoridating, lead levels in water in old buildings and in blood would drop dramatically.
Seattle commissioned some early reports on the subject. Not one report even mentioned the possibility of a connection between lead levels and fluoridation! It is politically risky to mention anything critical about fluoride. Seattle began replacing pipes in schools – at enormous expense. Terminating fluoridation greatly reduce lead leaching, very quickly, and at no cost. Moreover, even if replacing pipes in schools solves the problem there, it would not solve the problem in old homes, old apartment buildings, old hospitals, old office buildings, and old factories.
BLINDSPOT. Chemical, pharmaceutical, fertilizer, and toothpaste companies donate heavily to dental and medical colleges, which indoctrinate dentists and physicians to support fluoridation. Fluoridation continues because we have been programmed to trust government agencies and those with MD and DDS after their names. It has become an article of faith. The ADA tells dentists that they need not try to understand the science behind fluoridation. They need only accept the mystery and spread the gospel of fluoridation. Dentists who question it have been excommunicated. Politicians who oppose it have to contend with the bottomless war chest of the pro-fluoride dental lobby.
ARSENIC. SiF also contains arsenic, a confirmed Type 1, Class A human carcinogen. For arsenic the MCL is 10 ppb and the MCLG is zero. A zero MCLG for lead and arsenic means that there is no level of lead or arsenic which can safely be added to drinking water.
SiF AND NAF are carcinogens, mutagens, poisons. As little as seven grams of SiF or NaF, the weight of seven paper clips, can kill an adult. It would take a half pound of naturally occurring CaF to do the same. The .8 milligram of SiF per liter which our cities add to water is of course not immediately fatal, however, a healthy adult is only able to excrete half of all fluoride consumed, while the body retains the other half. Fluoride seeks out calcium and is retained in bones and other calcium rich areas of the body. Once in our bones, fluoride has a long half life and can be excreted only slowly – or if we continue to consume fluoride, not at all.
KIDNEYS at best only excrete half the fluoride we consume. The effect is cumulative. After a decade of drinking fluoridated water, our bones can be around 5,000 ppm fluoride, and it can make us stiff, lethargic, and depressed. In our 50s and 60s, bone and other tissues can be up to 12,000 ppm fluoride, depending on water hardness and diet, making bones brittle. Fractured pelvises are twice as common in fluoridated areas. One who drinks fluoridated water all his life will be less healthy as he ages and may have a shorter life span.
SYMPTOMS. Fluoride of all kinds affects bones, joints, and tendons and exacerbates arthritis. SiF is an acetylcholinesterase inhibitor and a general enzyme inhibitor. Fluoride denatures proteins. It slowly attacks the thyroid, pituitary, pineal, and other glands. Fluoride builds up in the kidneys and prevents them from functioning normally and hastens death by kidney failure. Those on dialysis who quit consuming fluoride may recover and some may be able to quit dialysis.
ALZHEIMER’S. The fluoride ion binds with aluminum, which is added to water to precipitate dirt. Aluminum fluoride passes the blood-brain barrier, delivering aluminum into the brain, which is believed to cause or worsen Alzheimer’s disease.
BLACKS, HISPANICS, AND THE POOR in general are more sensitive to lead, arsenic, and fluoride than the general population. Alveda King, Bernice King, and Andrew Young lead the Fluoride-Gate movement. They see fluoridation as a new civil rights issue because it hits minorities hardest.
BABIES are highly sensitive to lead, arsenic, and fluoride because their cells are still dividing and because they drink so much fluids relative to their body weight. Their kidneys are not mature and excrete only 20% of fluoride consumed. CDC, ADA, AMA, and the surgeon general have advised that if formula is mixed using fluoridated water fluorosis will result. The poor are unable to buy fluoride-free water home or filter out the fluoride. Only an expensive reverse osmosis filter or distiller can remove the tiny fluoride ion. The poor are definitely being harmed, poor babies in particular. We are all being harmed, some more quickly than others.
ATHLETES, HARD LABORERS, DIABETICS, and those with kidney disease are highly vulnerable because they drink up to ten times as much water as typical people. Fluoride is a drug, but the dose cannot be controlled.
IN WESTERN WASHINGTON, we are especially susceptible to the slow but certain ravages of fluoride because our snow melt water is exceptionally soft and contains little calcium, which would bind with and tie up fluoride to some extent.
TOXIC WASTE. The silicofluoride used is the unfiltered and unprocessed scrubber liquor from the smoke stacks of phosphate fertilizer plants in Florida, Louisiana, Mexico, and China. It contains trace amounts of nearly every element on the periodic table. It is not pharmaceutical grade. SiF has never been approved by the FDA, EPA, or any other federal or state agency for consumption in tap water. Fluorides have been approved for topical use, as in toothpaste, but the fluoride is to be spat out. If it is swallowed, one is to call poison control.
THE NATIONAL SANITATION FOUNDATION – NSF – is a chemical company trade association, funded by EPA to certify fluoride as safe and to approve its use. Washington and some 42 other states require that only NSF 60 fluoride be used. NSF claims on its web site and in the NSF 60 book that it obtains health and toxicological studies, however, this is a lie. NSF operates as a sham FDA.
THE OFFICE OF DRINKING WATER, one small branch within the CDC, run by pro-fluoridation dentists, pushes fluoridation, but the CDC has no authority whatsoever to approve or disapprove fluoridation. The CDC, EPA, and the surgeon general all endorse fluoridation. The CDC claims it is one of the greatest health advances of the 20th Century. However, endorsements prove nothing. One must look at the science. Following release of the 2006 National Research Council Report on Fluoridation, it is clear that fluoridation is instead one of the greatest frauds of the 20th Century.
SCRUBBER LIQUOR. Cities buy SiF by the tanker truck load and pour it at a steady rate, day after day into our water. Fluoridation is expensive. SiF particularly corrodes equipment and shortens its useful life. Hazmat suits must be worn to handle SiF. When the liquid is spilled on concrete, it burns a hole through it, as it will do to steel and glass. In this era of declining tax revenues and budget cuts it is hard to justify adding dilute toxic waste to drinking water. For every ton of SiF added to water, one must add a half ton of sodium hydroxide or sodium carbonate – Draino® or soda ash.
NO INFORMED CONSENT. Fluoride is not a mere additive such as chlorine, which is there to kill microbes. Chlorine evaporates out of water overnight if left in an open pitcher. Fluoride is intended as medication and delivered without inquiry into preexisting conditions or conflicts with other drugs being taken, without informed consent, with no control over dose or duration of use, and without prescription.
TOOTH DECAY. Fluoride is added allegedly to reduce caries, however, documents posted on the CDC website claim only an 18-25% reduction in caries. Other credible studies show no reduction. Tooth decay has dropped just as much in non-fluoridated Europe as in fluoridated United States, so fluoridation cannot be the causal factor.
TOPICAL. Documents posted on the CDC website admit that the effect of fluoride on teeth is topical and not systemic, but strangely, CDC still endorses drinking fluoride. Other documents there admit that 41% of children 12 – 15 years old have dental fluorosis, while 8.6% suffer from mild fluorosis (white spots and some brown spots with up to 50% of enamel impacted), and 3.6% suffer from moderate and severe fluorosis (white spots and brown spots and sometimes pitting and chalky teeth and up to 100% of enamel impacted). Fluorosis can be ugly. Fluorosis should not be forced on people just so tooth decay can allegedly be reduced and then only slightly, if at all. The way to cut tooth decay is to quit eating and drinking sugary junk foods and to eat more vegetables.
PERVASIVE. If we add fluoride to tap water, then fluoride is in everything made from tap water – cola, beer, coffee, soup, bread, cereal, restaurant food, and fruit juices reconstituted with tap water.
NOTICE OF POTENTIAL LIABILITY have been served on Seattle and Everett in connection with the lead, arsenic, and fluoride which they add to our water. Cities should consult with their insurance carriers to confirm they will be covered when the class action and mass toxic tort actions come. There should be a moratorium on fluoridation in order to reverse the burden of proof, which should be on the city wanting to add fluoride, not on those who want it removed. Failure on the part of these cities to look at the science regarding fluoridation constitutes reckless indifference to the harms caused and expose cities to liability.
SMALLER WATER DISTRICTS, those which must buy fluoridated water from Seattle and Everett should demand that they receive non-fluoridated water. Their citizens never voted on fluoridation. In the meantime they should demand that they be held harmless from liability.
CLEAN AND PURE WATER is a fundamental human right. Forcing us to take a drug violates our right to control our own bodies. It should not be our duty to remove the toxic waste. Water departments should stop adding it.
WHAT YOU CAN DO:
Join email lists of www.WashingtonSafeWater.com, www.Fluoride-Class-Action.com, and also www.FluorideAlert.com. Attend city council meetings and make three minute speeches during public comment period. Keep speaking and keeping writing until politicians respond. Send a fluoride questionnaire to all elected officials. Make them take a position. Look here for email addresses for Everett and Seattle councils.
RECRUIT ATTORNEYS to work on this project on a pro bono basis and send Notice of Potential Liability. (Attorneys, I encourage you to do this meaningful, at least at this stage, on a pro bono basis. Eventually fluoride lawsuits will be bigger than asbestos suits, and these cases can be profitable.) Attorneys can quickly put Fluoride Class Action and Washington Action for Safe Water documents on their own letterhead.
More reading: Letters to HHS and EPA, 50 Reasons to Oppose Fluoridation. The PR manipulators who sold us fluoride are the same ones who sold us tetraethyl lead.
Print this flier in quantity. You will find the Word version here. Hand them out. Forward them by email to others.
James Robert Deal, Attorney, WSBA Number 8103, President, Fluoride Class Action.
James@Fluoride-Class-Action.com 425-771-1110
MIAMI — A growing number of communities are choosing to stop adding fluoride to their water systems, even though the federal government and federal health officials maintain their full support for a measure they say provides a 25 percent reduction in tooth decay nationwide.
Last week, Pinellas County, on Florida’s west coast, voted to stop adding fluoride to its public water supply after starting the program seven years ago. The county joins about 200 jurisdictions from Georgia to Alaska that have chosen to end the practice in the last four years, motivated both by tight budgets and by skepticism about its benefits.
Eleven small cities or towns have opted out of fluoridating their water this year, including Fairbanks, Alaska, which acted after much deliberation and a comprehensive evaluation by a panel of scientists, doctors and dentists. The panel concluded that in Fairbanks, which has relatively high concentrations of naturally occurring fluoride, the extra dose no longer provided the help it once did and may, in fact, be harmful.
It is a view that also was shared by four out of seven commissioners in Pinellas County who first raised the proposal as a cost cutting measure.
“I’m in opposition to putting a medical treatment into the public drinking water supply without a vote of the people who drink that water,” said Norm Roche, a newly elected Republican county commissioner who spent 10 years doing policy research for the county Water Department and who led the turnaround effort. “We had a dozen to 15 doctors, dentists, dental hygienists and chemists here who want us to continue this practice but who could not agree themselves on how best to use fluoride.”
Some 700,000 people — 75 percent of the county — will be affected by the vote. The rest receive water from a different source.
But the United States Public Health Service and the Centers for Disease Control and Prevention say that the communities that stop adding fluoride to the water supply are misguided. The government continues to recommend the practice, which began in the 1940s and has had its share of recent successes, including San Diego’s move to fluoridate water this year after a long delay. Some 72 percent of the population in the country drinks water with added fluoride.
Keeping fluoride in water is especially important today because many people cannot afford dental care, public officials say.
“We have had big wins and significant losses,” Dr. William Bailey, chief dental officer for the Public Health Service and acting director for the Centers for Disease Control and Prevention’s division of oral health, said about the skirmishes over fluoridation. “Fluoridation helps people of all ages and income groups. And it helps people who can’t get in to receive care.”
The movement to stop fluoridating water has gained traction, in large part, because the government has recently cautioned the public about excessive fluoride. A report released late last year by the Centers for Disease Control and Prevention linked fluoride to an increase among children in dental fluorosis, which causes white or yellow spots on teeth. About 40 percent of children ages 12 to 15 had dental fluorosis, mostly very mild or mild cases, from 1999 to 2004. That percentage was 22.6 in a 1986-87 study.
Fluorosis is mostly a cosmetic problem that can sometimes be bleached away. But critics argue that spotted teeth are a warning that other bones in the body may be absorbing too much fluoride. Excessive fluoride can lead to increases in bone fractures in adults as well as pain and tenderness.
“Teeth are the window to the bones,” said Paul Connett, a retired professor of environmental chemistry and the director of the Fluoride Action Network, which advocates an end to fluoridated water.
Experts say that one possible factor in this increase may be that fluoridated water is consumed in vegetables and fruit, and juice and other beverages as well as tap water. And the consumption of beverages continues to increase.
In January, the federal Department of Health and Human Services recommended reducing the fluoride put into the water supply to 0.7 milligrams per liter of water. The longtime standard had ranged from 0.7 to 1.2 milligrams per liter. At the lowest level, the risk of fluorosis is decreased, the government says.
The government also informed parents of infants who exclusively use infant formula reconstituted with fluoridated water that their children face an increased risk of fluorosis and suggested they use low-fluoride water, like distilled water, some of the time. “It was a trigger,” said Mr. Connett. “People who had heard there is nothing wrong with fluoridation all of the sudden are hearing that kids are getting too much fluoride.”
Money worries and a growing distrust of government have also helped invigorate the movement. With the recession squeezing budgets and the cost of fluoride increasing (some fluoride is imported), communities have been more willing to take a look at the issue.
For decades, the issue of fluoridated water remained on the fringes. The John Birch Society took up the cause, seeing fluoride as a communist plot to poison the nation. References to Nazis using fluoride to pacify prisoners in concentration camps — a claim that was never proved — circulate even today. At least one person at the Pinellas County meeting made reference to both the Soviets and the Nazis.
But as more places, like Fairbanks and parts of Canada, take up the issue in a more measured way, it is shifting away from conspiracy and toward the mainstream.
The conclusion among these communities is that with fluoride now so widely available in toothpaste and mouthwash, there is less need to add it to water, which already has naturally occurring fluoride. Putting it in tap water, they say, is an imprecise way of distributing fluoride; how much fluoride a person gets depends on body weight and water consumed.
Doctors, scientists and dentists, including Dr. Bailey of the Public Health Service, mostly agree that fluoride works best when applied topically, directly to the teeth, as happens with brushing.
“The fact that no one really knows what dosage a given person receives from fluoridated water makes the subject of benefits and harms very difficult to quantify,” said Rainer Newberry, a professor of geochemistry at University of Alaska, Fairbanks, who sat on the committee that studied the issue prior to the June vote in Fairbanks. “And this presumably explains the number of studies with diverging conclusions.”
But Kenneth T. Welch, a Pinellas County commissioner who voted to continue adding fluoride to the water, said he was stunned by the commission’s decision, saying it was pushed by Tea Party supporters. He called for another vote on Tuesday but the outcome was the same. Fluoridation will end in the affected areas of the county by Dec. 31. The county expects to save $205,000 annually from halting fluoride use.
“Political rhetoric won out over science and the best advice of our medical and dental community,” Mr. Welch said.
Where does your politician stand on silico-fluoridation?
It is important to ask him or her.
Ask every politician on your email list where they stand on silico-fluoridation.
Give them options, listed here in no particular order:
1. I have spent at least ten hours studying the articles on your www.Fluoride-Class-Action.com web site as well as CDC, EPA, FDA, NSF web sites, and I have concluded that I strongly support fluoridation.
2. I have spent at least ten hours studying the articles on your www.Fluoride-Class-Action.com web site as well as CDC, EPA, FDA, NSF web sites, and I have concluded that I strongly oppose silic0-fluoridation.
3. I have not read anything on this subject. I am willing to spend at least ten hours reading the articles on the www.Fluoride-Class-Action.com web sites and also the CDC, EPA, FDA, NSF web sites, and I am willing to say I will vote in favor of a six-month moratorium on fluroidation. There is evidence that harm is being done. We should not ignore that.
4.
(This page is not done yet, but I will share what I have thus far. JRD 10-13-11.)
By Mary Shomon, About.com Guide
Updated December 15, 2003
About.com Health’s Disease and Condition content is reviewed by our Medical Review Board
Wednesday January 24, 2001 –Cavity rates declined in several cities that stopped water fluoridation, new studies report, contradicting American Dental Association (ADA) predictions, according to Fluoride Action Network.
Fluoride added to over 62% of US water supplies is supposed to reduce tooth decay but these six studies from dental journals show it hasn’t and, in fact, may have increased the likelihood of rotten choppers.
A recently released government report out of Canada (7) shows similar negative results and offers a reason.
Fluoridation was launched in the 1940′s when dentists believed fluoride’s beneficial effects were achieved internally, through the bloodstream then absorbed inside the teeth. The Canadians report that “this effect is likely to be minor…The evidence for a post-eruptive (topical) effect,… is much stronger.”
Therefore, swallowing fluoride doesn’t reduce tooth decay but does cause dental fluorosis — white spotted, yellow or brown stained and sometimes pitted teeth.
According to the ADA’s website “Dental decay can be expected to increase if water fluoridation in a community is discontinued for one year or more, even if topical products such as fluoride toothpaste and fluoride rinses are widely used.”
“Well, science proves the ADA is wrong about the claimed benefits of water fluoridation and they are wrong about the safety of water fluoridation, too” says lawyer Paul Beeber, President, New York State Coalition Opposed to Fluoridation. “Studies have linked fluoridation chemicals to increased blood lead levels, neurological defects, brittle bones, thyroid cancer and more,” says Beeber. “It’s time for the media to challenge the science that supports water fluoridation and present the truth to the public. We’ve made it easy for the media to access the medline abstracts via the links below. No more excuses.”
Other US government studies and statistics support the findings of these six studies and the Canadian government report. For example, children in fluoridated-since-1945 Newburgh, New York, have no less tooth decay but significantly more dental fluorosis than children from never-fluoridated Kingston, New York, according to Community Dentistry and Oral Epidemiology June 1999.
CONTACT: Paul Beeber, President, NYS Coalition Opposed to Fluoridation, 516-433-8882, or nysocf@aol.com; or Paul Connett, Ph.D., Professor of Chemistry, St. Lawrence University in Canton, 315-379-9200, or ggvideo@northnet.org, Fluoride Action Network
PRESS RELEASE SOURCE: New York State Coalition Opposed to Fluoridation, Inc. / Fluoride Action Network
October 11, 2011
RENEWED NOTICE OF POTENTIAL LIABILITY
PROFITABLE FRAUD BY CHEMICAL COMPANIES
LEAD, ARSENIC, SILICOFLUORIDE ADDED TO DRINKING WATER
Notice of Liability Served on Seattle and Everett
Suit Filed in Federal Court in San Diego
Suit Filed in Federal Court in Maryland
http://fluoride-class-action.com/occupy-seattle-flier-10-10-11
DO NOT IGNORE THIS NOTICE
YOU MUST RESPOND IN WRITING
TO ALL THE ALLEGATIONS MADE HEREIN
Mayor Mike McGinn Seattle City Council Attorney Peter Holmes
Dear Friends,
On August 8 a dozen of us came to City Council to speak during public comment period. I am writing on behalf of the six groups which were represented. Fluoride Class Action, Washington Safe Water, Americans for Liberty, Fluoride Detective, Dentists Against Fluoridation, and Physicians Against Fluoridation.
We called ahead and talked with Nick Licata’s assistant. I was aware there is a rule that can require that new issues be taken up first with a committee. I asked the assistant if the rule would be waived. He said that the Council would hear us. Unfortunately, the Council refused to let us speak.
Nevertheless, we did deliver to the Council a Notice of Potential Liability. We delivered copies to the clerk, to Mr. Brian’s office, to Mayor McGinn’s office, and to City Attorney Peter Holmes’s office.
Two months have gone by. We received two short emails from Assistant Fogt which were full of inaccuracies and which did not address all the points we raised. However, there has been no response which even begins to address the evidence we presented.
We are demanding a written response to these documents:
Notice Of Liability To Seattle For Water Contamination
Notice To Consult With Insurance Carrier
http://fluoride-class-action.com/seattle/notice-of-liability-to-seattle-8-8-2011
Profitable Fraud By Chemical Companies – Lead, Arsenic, Silicofluoride Added To Drinking Water – Notice of Liability Served on Seattle and Everett – Suit Filed in Federal Court in San Diego – Suit Filed in Federal Court in Maryland,
http://fluoride-class-action.com/occupy-seattle-flier-10-10-11
Who or What is the NSF?
http://fluoride-class-action.com/sham
Fifty Reasons to Oppose Silico-Fluoridation
http://www.fluoridealert.org/50-reasons.htm
If even ten percent of the evidence we present is true, Seattle must impose an immediate moratorium on fluoridation.
You can no longer keep your head in the sand on this issue. We have made a prima facie case that there is serious evidence of harm.
The family of Martin Luther King Jr. and LULAC, the League of United Latin American Citizens, both say fluoridation is a civil rights issue. That is because the poor in general are disproportionately harmed. Babies are disproportionally harmed. Workers who sweat a lot a harmed. Kidney patients are harmed. Diabetics are harmed. Arthritics are harmed.
The crystal pure water of the Tolt and Cedar have been turned into highly dilute toxic waste. We demand that you give us “just water”.
People who want to consume fluoride can swallow some of their toothpaste. I advise against doing this. At least those who do so will be ingesting fluoride that is free of lead and arsenic.
Chlorine is acceptable providing you disclose to water users that they should install chlorine shower filters so they will not inhale chlorine. You should also disclose that if water is left out overnight most of the chlorine will evaporate. The eventual goal should be ozonation instead of chlorination.
Cleaning up the water will be an issue in the November election. We are demanding our human right to have “just water” coming out of the tap – with no added lead, arsenic, silico-fluoride, or other heavy metals. If we want to ingest a toxic drug, we should have the right to make that decision. We should be advised by a physician, and we should be able to control the quality, the dose, and the duration.
Some of the smaller water districts surrounding Seattle will be asking for silico-fluoride free water. In the alternative, they will be asking Seattle to indemnify them in case of suits from their customers.
Seattle is likely to be sued over this, so the sooner it quits, the better its defense will be.
Seattle has several pipes coming down from the Tolt and Cedar, and some accommodation should be made to the water districts which request “just water”. New pipes should be laid if necessary.
For a pro-fluoridation dentist to prove his case he has to convince you that the following points are all true:
That drinking fluoride does reduce tooth decay.
That drinking fluoride does not harm teeth in any serious way.
That the positive effect of fluoride can only be obtained by drinking and eating the fluoride, not by applying it directly to teeth.
That fluoride does not harm babies and children.
That fluoride does not harm or interfere with thyroid function.
That fluoride does not harm or interfere with pineal function.
That fluoride does not harm or interfere with kidney function.
That fluoride does not harm or interfere with bones.
That fluoride does not harm or interfere with the gastric system.
That fluoride does not harm or interfere with or penetrate the brain and has no adverse affect on the brain.
He must prove all of these to be true statements. If I prove he is wrong on even one point, he loses the debate.
And the fact is that the pro-fluoridation dentists have already admitted that certain of these debate points. The CDC admits that 3.6% of kids are getting severe fluorosis, and the NRC says that most fluoride comes from drinking water and food made with drinking water. The CDC has also admitted that any effect is topical and not from ingestion of fluoride. The CDC has admitted that babies should not drink fluoridated water or formula made up with fluoridated water on a consistent basis.
And if all that were not enough there is the lead issue. Silicofluoride contains lead. More so than any other type of fluoride, it leaches lead out of brass-lead pipes. In 2004 there was lead in drinking water in old Seattle schools at 1,600 ppb. That is 1.6 ppm! That’s a higher concentration than the silico-fluoride. The school district is spending vast sums of money ripping out old lead-brass pipe and fittings. All they need to do is just stop fluoridating, add chlorine to disinfect and add an alkaline additive to raise the pH. Even if Seattle replaces all the pipes in old schools, that will not solve the problem. There will still be lead-brass pipes in old homes, old apartments, old office buildings, old commercial buildings. The fluoride religion is so strong that none of the reports on the problem even once mention that the silico-fluoride could be causing the leaching. There should be an inquest on this particular issue.
So why are we still fluoridating? Because fluoridation doubles as a way to get rid of toxic waste, and at a profit to boot. Chemical companies donate to medical and dental colleges, so faithful medical and dental alumni evangelize far and wide, most of them believing the Big Lie. They have not been able to find their way out of the maze.
We demand that this matter be put on the regular agenda, that a temporary moratorium be implemented, and that the city hold hearings and hear from experts.
Sincerely,
James Robert Deal, Attorney WSBA Number 8103
Posted at: www.fluoride-class-action.com/notice-of-liability-to-seattle-10-11-11
http://fluoride-class-action.com/hempfest-2011
August 20, 2011
Seattle, Everett, Tacoma and other cities use silicofluoride as the fluoridation material they add to their drinking water. Silicofluoride and sodium fluoride are much more toxic than naturally occurring calcium fluoride. Calcium fluoride can be the most pure; sodium fluoride is industrial grade but relatively free of contaminants; silicofluoride is industrial grade toxic waste and highly contaminated with heavy metals.
Silicofluoride contains lead. http://www.nsf.org/business/water_distribution/pdf/NSF_Fact_Sheet.pdf. The EPA maximum contaminant level (MCL) for lead is 15 ppb, and the maximum contaminant level goal (MCLG) is zero. Lead permeates all cells in the body, reduces IQ, and causes kidney disease and high blood pressure.
In 2004, the Seattle papers reported that lead at up to 1,600 ppb was found in drinking water in old Seattle schools. Silicofluoride, unlike more expensive sodium fluoride, leaches lead out of brass pipes. http://www.fluoridealert.org/sf-masters.htm.
New brass pipes contain around 8% lead and older pipes contain as much as 30% lead. All old schools, old homes, old apartment buildings, old hospitals, old office buildings, and old factories can be expected to contain brass pipes with high lead content, which silicofluoride will leach out. http://fluoride-class-action.com/hhs/comments-re-lead.
If water districts stopped fluoridating with silicofluorides, lead levels in water in old buildings would drop dramatically and lead levels in blood would drop dramatically. http://www.fluoridealert.org/sf-masters.htm.
After commissioning some early reports on the subject, Seattle government on all levels has ignored this issue. The lead problem has not been resolved. Reports on the lead problem do not even mention the possibility of a connection between lead levels and fluoridation!
Fluoridation exists within a blindspot. It has become an article of faith. One is told not to try to understand the mystery but to believe in it fervently nevertheless. When it comes to politics, one is saved by faith in fluoride. A politician who opposes fluoridation will have to contend with the wrath and bottomless war chest of the pro-fluoride dental lobby, who probably get their money indirectly from the silicofluoride manufacturers.
Silicofluoride also contains arsenic, a confirmed Type 1, Class A human carcinogen. For arsenic the MCL is 10 ppb and the MCLG is zero. A zero MCLG for lead and arsenic means that there is no level of lead or arsenic which can safely be added to drinking water. http://www.fluoridealert.org/f-arsenic.htm
Silicofluoride has not yet been proven to be a carcinogen, but it is recognized as a poison. As little as seven grams of silicofluoride or sodium fluoride, the weight of seven paper clips, can kill a 70 kg adult. It would take a half pound of calcium fluoride to do the same. The one milligram of silicofluoride per liter which our cities add to drinking water is of course not immediately fatal, however, a healthy adult is only able to excrete half of all fluoride consumed, while the body retains the other half. Fluoride seeks out calcium, and is retained in calcium rich areas of the body. Once in our bones, fluoride can never be removed.
The effect is cumulative. After a decade or less of drinking fluoridated water, our bones can be around 5,000 ppm fluoride, and as a result we feel stiff and lethargic. In our 50s and 60s, bone and other tissues can be up to 12,000 ppm fluoride, depending on water hardness and one’s diet, making bones brittle. Fractured pelvises are twice as common in fluoridated areas. One who drinks fluoridated water all his life will be less healthy as he ages and may have a shorter life span.
Silicofluoride affects bones, joints, and tendons and exacerbates arthritic symptoms. Silicofluoride is an acetylcholinesterase inhibitor and a general enzyme inhibitor. It denatures proteins. It slowly but surely attacks the thyroid, pituitary, pineal, and other glands. Fluoride builds up in the kidneys and prevents them from functioning normally and hastens death by kidney failure. Those on kidney dialysis may find that their kidneys would heal if they would stop drinking fluoridated water. http://fluoridedetective.com/2011/02/07/kidney-patients-beware
Silicofluoride breaks down in such a way that the fluoride ion binds with aluminum. Aluminum fluoride passes the blood-brain barrier, delivering aluminum into the brain, which is believed to cause or worsen Alzheimer’s disease.
Blacks, Hispanics, and the poor in general are more sensitive to lead, arsenic, and silicofluoride than the general population. Alveda King, Bernice King, Andrew Young see fluoridation as a new civil rights issue. http://fluoride-class-action.com/alveda-king-andrew-young-against-fluoride.
Babies are most sensitive because their cells are still dividing, because they are growing fast, and because they drink so much fluids relative to their body weight. CDC, ADA, AMA, the surgeon general, and others have advised that formula not be mixed using fluoridated water. But the poor are unable to buy and haul fluoride-free water home or filter it out. Only an expensive filter or distiller can remove the tiny fluoride ion. This is an admission that the poor a definitely being harmed, poor babies in particular.
Athletes, hard laborers, and those with diabetes and kidney disease are highly vulnerable because they drink up to ten times as much water as typical people. The dose cannot be controlled.
In all of Western Washington, we are especially susceptible to the slow but certain ravages of fluoride because our snow melt water is exceptionally soft and contains little calcium, which would bind with and tie up fluoride.
The silicofluoride used is the unfiltered and unprocessed scrubber liquor from the smoke stacks of phosphate fertilizer plants in Florida, Louisiana, Mexico, and China. It contains trace amounts of nearly every element on the periodic table. http://www.purewatergazette.net/fluorideandphosphate.htm. It is not pharmaceutical grade. Silicofluoride has never been approved by the FDA, EPA, or any other federal or state agency for consumption in public drinking water. Fluorides have been approved for topical use, as in toothpaste, but the fluoride is to be spat out. If it is swallowed, one is to call poison control.
Silicofluoride is only approved by NSF, the National Sanitation Foundation, a chemical company trade organization which operates as a sham FDA. http://fluoride-class-action.com/sham.
One small Office of Drinking Water within the CDC pushes fluoridation, but the CDC has no authority whatsoever to approve or disapprove fluoridation. The CDC, EPA, and the surgeon general all endorse fluoridation. The CDC claims it is one of the ten greatest health achievements of the 20th Century. However, endorsements do not prove anything. One must look at the science. Following release of the 2006 National Research Council Report on Fluoridation, it is clear that fluoridation is instead one of the ten greatest frauds of the 20th Century. http://www.nap.edu/catalog.php?record_id=11571
Cities buy silicofluoride scrubber liquor by the tanker truck load and dribble it into our water. Fluoridation is an expensive. Silicofluoride corrodes equipment and shortens its useful life. Hazmat suits must be worn to handle silicofluoride. When the liquid is spilled on concrete, it burns a hole through it, as it will do to steel and glass. In this era of declining tax revenues and budget cuts it is hard to justify adding dilute toxic waste to drinking water. For every ton of silicofluoride added to water, one must add a half ton of sodium hydroxide. That’s right, we are adding Draino® to our drinking water.
Silicofluoride is not a mere additive such as chlorine, which is added to kill bacteria. Chlorine evaporates out of water overnight if left in an open pitcher. Silicofluoride is intended as medication and delivered without prescription, without inquiry into preexisting conditions and contraindications or conflicts with other drugs being taken, without informed consent, and with no control over dose or duration of use.
Silicofluoride is added allegedly to reduce tooth decay, however, documents posted on the CDC website claim only a 17-25% reduction in tooth decay. Other credible studies show no reduction. Tooth decay has dropped just as much in non-fluoridated Europe as in fluoridated United States, so fluoridation cannot be the causal factor.
Documents posted on the CDC website admit that the effect of fluoride on teeth is topical and not systemic, but strangely, CDC still endorses drinking fluoride. Documents on the CDC website admit that 41% of children 12 – 15 years old have at least mild fluorosis (white spots), while 8.6% suffer from moderate fluorosis (brown spots), and 3.6% suffer from severe fluorosis (brown spots and pitting). Fluorosis can be ugly. Fluorosis should not be forced on people just so tooth decay can allegedly be reduced and only slightly. The way to cut tooth decay is to quit eating junk food and drinking pop.
Seattle and Everett have been served Notice of Potential Liability in connection with the lead, arsenic, and silicofluoride which they add to drinking water. Cities should consult with their insurance carriers to confirm they will be covered when the class action and mass toxic tort actions come. Cities can reduce their liability by instituting an immediate one-year moratorium on fluoridation, thus showing good faith after all these years of fluoridating unquestioningly and without understanding the science. Failure on the part of these cities to look at the science regarding fluoridation will constitute reckless indifference to the harms caused and expose them to liability.
About Fluoride Class Action: Our method is first, to warn cities that the fluoridation suits are coming. We explain how fluoridation does not reduce tooth decay and is therefore a waste of money, and that fluoridation causes harm in many ways and thus that cities can be held liable for large damage awards. Second, we equip citizens with the tools they need to carry on this process, each in their own community – notices of liability, freedom of information FOIA requests, short speeches, and sample lawsuit documents. Third, we encourage groups to recruit attorneys to work on this project. Attorneys have a non-binding duty to do pro bono work, and so attorneys are always looking for interesting and fulfilling pro bono work to do. Attorneys can quickly put the Fluoride Class Action documents on their own letterhead and make a big impact right away. We want local attorneys to warn their cities of potential liability and as well to prepare for suit.
More reading:
Letters to HHS and EPA:
http://fluoride-class-action.com/hhs/report-card-for-hhs.
http://fluoride-class-action.com/hhs/comments-re-lead.
Suit filed in federal court in San Diego: http://fluoride-class-action.com/san-diego-suit
Tetraethyl lead, foisted on America by the same Kettering Institute which conned America into fluoridating. http://fluoride-class-action.com/speeches/tetraethyl-lead
NSF – National Sanitation Foundation – a chemical company trade association, funded by EPA to certify silicofluoride to be safe and approved for use, thus operating as a sham FDA. http://fluoride-class-action.com/sham
50 Reasons to Oppose Fluoridation
What you can do:
Make speeches – Visit your city and county council, water district, school district. Make 3-minute speeches during public comment period. Start with our sample speeches. More will be posted soon. http://fluoride-class-action.com/speeches. Or just read paragraphs off this flier for three minutes.
Send a fluoride questionnaire to all elected officials. http://fluoride-class-action.com/action-plan/questionaire-to-pols
Warn of Liability – Send Notice of Potential Liability to elected councils.
http://fluoride-class-action.com/seattle/notice-of-liability-to-seattle-8-8-2011
Print more of these fliers. The Word version is at :
http://fluoride-class-action.com/wp-content/uploads/hempfest-flier.
James Robert Deal, Attorney, WSBA Number 8103 President, www.Fluoride-Class-Action.com Vice-President, www.WashingtonSafeWater.com Member, www.FluorideDetective.com
News Report: http://newsminer.com/bookmark/13889457-Fairbanks-City-Council-halts-additional-fluoride-in-city-water
Dr. Heard, a dentist in Hereford, Texas, back in the 1940s, is possibly responsible for the beginning of the myth that fluoride prevents tooth decay. Later he rejected that notion, arguing that it was not just the fluoride but all the other nutrients and minerals in the diet in Deaf Smith County, Texas. Dr. Hurd did not say so, but other sources say that the calcium levels in Hereford water were around 328 ppm, and that it was the calcium and not the calcium fluoride which caused the beautiful milky white teeth and the low rate of cavities.
On January 29, 1942, the popularly syndicated newspaper feature “Ripley’s Believe It Or Not” called Hereford, Texas “The Town Without a Toothache.” Dr. George W. Heard practiced dentistry in Hereford, and in 1939, Dr. Edward Taylor of the Texas Department of Health conducted a two-year study that showed that Hereford had the lowest rate of tooth decay of any city in the United States. The results were presented to the American Dental Association. Collier’s magazine also called Hereford “The Town Without a Toothache” in 1942.
Texas Escapes
Hereford Historical Marker
Title: Town Without a Toothache
Year Marker Erected: 1967
Marker Location: Located at little park on US 385 at 4th and Bennett Streets.
Marker Text: Hereford’s “miracle water” was brought to national fame in 1941 when Dr. Edward Taylor, State Dental Officer, told the American Dental Association that tooth decay was almost unknown here. This ideal situation had been discovered by a local dentist, Dr. George Heard, originally from Alabama. In a cross-section survey, dentists found that few local people had dental cavities. Hereford’s mineral-rich water and soil are thought to prevent tooth decay. Demand arose for Hereford water to be shipped all over the U.S. and to foreign nations.
Handbook of Texas Online
HEREFORD, TEXAS. Hereford, the county seat and principal town of Deaf Smith County, is on U.S. Highway 60 near the southeast corner of the county. When the Pecos and Northern Texas Railway was completed in 1899 from Amarillo to Farwell, it occasioned the growth and development of a new town, initially called Blue Water for the waters of Tierra Blanca Creek, one mile to the south. When federal postal authorities found that there was already a town in Texas with the name Blue Water, the residents renamed the settlement Hereford, after the cattle brought to the area by ranchers L. R. Bradley and G. R. (Rat) Jowell. By September 1898 W. H. Clair, Troy Womble, and C. G. Witherspoon (later a holder of various city and county offices) had established the new town’s first homes and businesses. Because of the approaching railroad, in November residents of Deaf Smith County chose Hereford to replace La Plata as the county seat. The original wooden frame courthouse, transported by wagon to the new site, was used until the completion of a marble-faced structure in 1910.
(…)
The city’s reputation as the “town without a toothache” evidently began in 1948, when Dr. F. M. Butler attributed local dental health to natural fluoride in the area’s water. Butler’s discoveries were later verified by the Texas Department of Health.qv Over the years Hereford water came to be in worldwide demand, as did its grain products, which are widely sold in for health-food stores.
Amarillo Globe News
Web posted Friday, May 19, 2000
Dr. G. W. Heard
By Jessica Raynor, Globe-News regional writer
Dr. George W. Heard was responsible for Hereford’s national fame as “the town without a toothache.” He shared findings that food had much to do with maintaining good teeth and was the only Hereford dentist involved in the discovery of fluoride in water.
Heard was born in 1867 in Alabama, seventh of 13 children. He left home at 19. He eventually made his way to Nashville, where he went to dentistry school, graduating fifth in his class.
He came to Hereford with his wife, Mattie, and opened a dental practice in either 1913 or 1916 – historical accounts differ.
Their only child, George, was born in 1911. Mattie died in 1947.
By 1910, he had begun sharing his “unorthodox” ideas that diet was connected to dental health. One doctor said, “If all our patients adhered to Dr. Heard’s ideas, we would be minus patients.”
He said “food in the rough” and raw milk helped people in Deaf Smith County keep good teeth. He would reiterate that finding when he attended sessions of the Panhandle District Convention of the Texas Dental Association at Amarillo.
Dr. Edward Taylor, director of dental health for the Texas Department of Health, came to Hereford in 1939 to check out Heard’s findings. A two-year study conducted by Taylor showed Hereford to have the lowest tooth decay rate among schoolchildren of any city in the United States.
Surveys also showed that the fluoride level in Deaf Smith drinking water was about one part per million, which became standard in artificial fluoridation. The fluoride apparently was responsible for quicker healing of broken bones.
Taylor told the research section of the American Dental Association that this might prove to be “one of the most important discoveries in dental history.” Collier’s magazine in 1942 printed an article about it, titled “The Town Without a Toothache,” a slogan that stuck in Hereford.
(…)
Heard’s autobiography, “Man Vs. Toothache,” was published in 1953. He died in 1965.
George Heard Correspondence
George W. Heard, D.D.S.
Box 346
Hereford, Texas
March 15, 1954
Mr. Roby C. Day
112 Lewis St.
San Diego, Calif.
Dear Mr. Day:
Hereford, Texas has been called the town without a toothache. This is not true. But the phrase has been used effecively by the people interested in marketing “sodium fluoride” all over the country.
I have practiced dentistry here for years. The native population of Hereford and Deaf Smith County have remarkably good teeth. The incidence of caries or tooth decay was very low. I finally succeeded in getting some members of the dental profession to come to Hereford to find the cause of the exellent dental health of our people.
After considerable research, it was suggested that the relatively high content of natural fluorine in our water supply was responsible. I accepted this conclusion for a time. The people who had great quantities of sodium fluoride and sodium silico fluoride as by-products of the aluminum and fertilizer industries decided that when these by-products were added to city water supplies, they would produce the same type of dental health which existed here with the natural fluorine. They widely publicized “the town without a toothache.” They are, I believe, still doing it.
As the years went by I continued to study the local situation. I observed that, as the town grew and more people began to live on processed foods, such as canned goods, white fluor products, soft drinks, etc., tooth decay increased. This increase of decay occurred, even though they were drinking the same fluorinated water we had always been drinking. I am now fully convinced that good natural food is the preventive of dental caries as well as other diseases.
I believe that fluorine does in a mild way retard caries, but I also believe that the damage it does if far greater than any good it may appear to accomplish. It even makes the teeth so brittle and crumbly they can be treated only with difficulty, if at all.
The dental investigators who came to our County some fifteen years ago did, in my opinion, make a serious misstake when they gave to fluorine the credit for our good teeth, and overlooked the quality of food grown in our rich, well mineralized soil. Every person I found who had no dental caries, consumed much milk.
Why use a poison, when correct food will maintain our bodies free from diseaases and tooth decay. It is hellish and un-American to put poison in city water supplies and force citizens to drink it.
I sincerely hope that at least some of your dentists are co-operating with you in getting the real truth about tooth decay over to your citizens.
If I can further assist you, please call on me.
Cordially yours,
George W. Heard
Note: This is an electronic reproduction of a photocopy of the Heard letter which was sent to me by Evangeline Winkler.
29 January 1942, Charleston (WV) Gazette, pg. 11:
BELIEVE IT OR NOT…BY RIPLEY
THE TOWN WITHOUT A TOOTHACHE!
HEREFORD, Deaf Smith County, Texas.
DUE TO CERTAIN ELEMENTS OF CLIMATE, WATER AND FOOD PRODUCTS IN THIS AREA, THE INHABITANTS ARE IMMUNE TO TOOTH DECAY.
30 January 1942, Lima (OH) News, pg. 8:
BELIEVE IT OR NOT…BY RIPLEY
EXPLANATION OF YESTERDAY’S CARTOON
THE TOWN WITHOUT A TOOTHACHE
At the 83rd annual convention of the American Dental-assn evidence was presented that Hereford, in Deaf Smith-co, Texas, has certain elements of climate, water, milk and food products of the soil that gives its inhabitants immunity from cavities and grant newcomers improved dental health.
This most wonderful discovery is expected to lead to duplication of the Hereford elements in soil and water elsewhere. The boon to humanity would be incalculable.
Posted by Barry Popik
Texas (Lone Star State Dictionary) • (5) Comments • Wednesday, November 22, 2006 • Permalink
See the 1997 National Science Council report on recommended intakes of vitamins and minerals
Starting at page 288, the report discusses various minerals, including fluoride, and presents fluoride as a needed nutrient, just like calcium and magnesium.
This is the same NSC which issued the 2006 NRC Report on Fluoride, the one which is so revealing about the harms which fluorides cause. Like the EPA and FDA, the NSC is a house divided against itself on various issues.
Ellijay, GA – Swirling questions about conflicts of interest and improper influence grew rapidly today as Freedom of Information Act documents showed that since the 1970s, dental health professionals alone in the Centers for Disease Control (CDC) have controlled the agency’s stance supporting water fluoridation.
A response to a request for the names and job descriptions of all persons in CDC that have had input into CDC’s decision to support fluoridation listed no CDC toxicologists, minority health professionals, experts in diabetes, or others outside the Oral Health Division.
CDC says its administrative structure is set up to address what the agency calls “cross cutting issues.” Yet only CDC’s directors of oral health were listed over several decades as being responsible for the agency’s fluoridation stance, a disquieting disclosure for water, health, and political leaders that believed CDC utilized its broad array of internal expertise in assessing research on whole-body, outside-the-mouth harm from fluoridation.
The documentation intensifies focus on the motivations behind CDC’s and EPA’s fluoride safety statements that appear at odds with current scientific knowledge.
After a 2006 report from the National Research Council documented extensive amounts of basic research never conducted on whole-body fluoride impacts, CDC continued promoting fluoridation while stating on its website, “Extensive research conducted over the past 60 years has shown that fluoridation of public water supplies is safe and effective for all community residents.”
The disclosures come as yet another prominent member of the Atlanta black community is calling for a halt to water fluoridation and highlighting concerns about the CDC’s role in promoting it.
Alveda King, nationally known minister and niece of civil rights leader Martin Luther King Jr., joins the civil rights leader’s daughter, Bernice King, former Atlanta mayor and U.N. ambassador Andrew Young, and civil rights leader and minister Dr. Gerald Durley in drawing attention to risks from fluoridation.
Alveda King posted information on her blog today. “The Centers for Disease Control has clearly been trying to preserve fluoridation at all costs, but the facts about fluoride harm are coming out anyway,” she says.
”This is a civil rights issue,” she continues. “No one should be subjected to drinking fluoride in their water, especially sensitive groups like kidney patients and diabetics, babies in their milk formula, or poor families that cannot afford to purchase unfluoridated water. Black and Latino families are being disproportionately harmed.”
A growing body of published research shows that minorities, kidney patients, diabetics, babies and seniors are particularly at risk for harm from ingested fluorides.
Law firms are now reviewing old and new documents believed to highlight a pattern of attempts to curtail discussions on fluoride toxicity and downplay the importance of professionals personally reviewing scientific reports about fluorides.
One such document is an explosive transcript of a 1951 meeting of state dental directors on file at the Library of Congress.
State dental leaders at the meeting were encouraged to promote fluoridation were told, “The question of toxicity is on the same order. Lay off it altogether. Just pass it over. ‘We know there is absolutely no effect other than reducing tooth decay,’ you say, and go on. If it becomes an issue, then you will have to take it over, but don’t bring it up yourself.”
A white paper issued by the American Dental Association in 1979 stated that, “Individual dentists must be convinced that they need not be familiar with scientific reports of laboratory and field investigations on fluoridation to be effective participants in the promotion program and that nonparticipation is an overt neglect of professional responsibility.”
“I think it’s pretty clear that the public, the media, and health providers were given soothing talking points about fluoridation, and in many cases dissuaded from personally looking at toxicity data,” says Daniel G. Stockin, a career public health professional who is opposed to fluoridation.
“How can CDC oral health professionals in a department that has promoted fluoridation for decades be objective, let alone competent to assess research and draw conclusions about the toxicity of fluorides on thyroid glands, kidneys, and the pineal gland?” he asks.
“There is a reason we’re seeing calls for Fluoridegate investigations,” Stockin continues. “The legal community and the media are waking up to this. I believe jurors will see a clear pattern of disinformation, half-truths, misdirection, and omission of critical material facts concerning harm from fluoridated drinking water.”
###
Reference Links / Sources:
* Freedom of Info. Act Request & Response: http://spotsonmyteeth.com/wp-content/uploads/2010/02/FOIA-use-send-ylw.pdf
* CDC statement on structure set up to address cross cutting issues: http://cdc.gov/about/organization/cio.htm
* CDC’s “60 years of extensive research” statement (see “Safety and Fluoridation”) : http://www.sboh.wa.gov/Meetings/2010/06-09/docs/Tab16h-Fluoridation_CDC_FAQs.pdf
* Alveda King blog: see June 22, 2011 post at: http://www.priestsforlife.org/africanamerican/blog/ Direct link: http://www.priestsforlife.org/africanamerican/blog/index.php/spotsonmyteeth-com-reveals-controversial-fluoride-issue
* National Research Council report on fluorides: see “Susceptible Subpopulations” pp. 350-51: http://books.nap.edu/openbook.php?record_id=11571&page=350 Harm to minorities – see Table 23 from CDC MMWR publication and other research references at: http://articles.mercola.com/sites/articles/archive/2011/06/05/poor-and-minority-americans-disproportionately-harmed-by-fluoride.aspx
* Transcript of 1951 meeting of state dental directors (see p. 23): www.nofluoride.com/PDF/State%20Dental%20Directors.pdf Original document on file at Library of Congress: call number RK21.C55 LC, control no.: 59062243, LCCN permalink: http://lccn.loc.gov/59062243 Meeting name: Conference of the State and Territorial Dental Directors with the Public Health Service and the Children’s Bureau. Main title: Proceedings. Published/Created: [Washington] U. S. Dept. of Health, Education, and Welfare.
* ADA White Paper on Fluoridation: see bottom p. 10: http://fluoridealert.org/ada.white.paper.1979.html
* Atlanta leaders on fluoridation: Bernice King Facebook page, see May 10, 2011 post: https://www.facebook.com/pages/Be-A-King/222731605570; Rev. Durley and Ambassador Young:
http://spotsonmyteeth.com/wp-content/uploads/2010/02/durley-ltr-bw-PDF2.pdf
* Fluoridation Litigation Article in American Association for Justice newsletter: http://www.justice.org/cps/rde/xchg/justice/hs.xsl/14815_14817.htm
NEWS RELEASE CONTACT:
Daniel G. Stockin, MPH The Lillie Center, Inc. P.O. Box 839 Ellijay GA 30540
Ph: 706-669-0786 email: stockin2@yahoo.com web: http://www.SpotsOnMyTeeth.com
(NaturalNews) Sometimes organizing like-minded individuals, petitioning, and showing up to city council meetings to express your thoughts actually does make all the difference in instigating positive change. Health-conscious individuals from Fairbanks, Ak., recently achieved a huge health freedom victory when their city council voted almost unanimously to end water fluoridation. The decision followed concerted public outcry and presentation of the facts surrounding the health damage caused by consuming fluoride.
Several years ago, the Fairbanks City Council created a “Fluoride Task Force” to investigate the issues surrounding fluoridation, and devise recommendations for whether or not to continue fluoridating the water supply. Composed of experts in chemistry, geochemistry, microbiology, medicine, and dentistry, the group eventually came to the conclusion that artificial water fluoridation puts the health of the population at risk, and should be stopped.
You can read the full Fluoride Task Force report, which is full of credible, scientific evidence against the use of fluoride in water supplies, here:
(http://www.ci.fairbanks.ak.us/docum…).
Based on the recommendations of the group, Fairbanks Mayor Jerry Cleworth introduced Ordinance 5849, which outlaws the addition of fluoride to the city’s water supply system. After more than an hour of public testimony and deliberation at a recent hearing, which was mostly against the use of fluoride, the Fairbanks City Council voted 5-1 to end water fluoridation beginning on July 1, 2011.
“There is no way to control how much (fluoride) a person drinks,” said Fairbanks resident Coert Olmsted at the meeting. He also cited credible information about how consuming fluoride internally, rather than having it applied topically, is highly toxic to the body.
This incredible health freedom victory in Fairbanks represents a model by which residents of other cities and towns that fluoridate their water can help end it as well. You can do your part by forwarding the Fairbanks Fluoride Task Force report to your own city councils, and urging them to read and consider it. You can also propose that they set up independent task forces of their own to investigate fluoride, which if done honestly will come to the same or similar conclusions about the dangers of fluoride.
Sources for this story include:
http://newsminer.com/bookmark/13889…
http://www.naturalnews.com/032741_water_fluoridation_Alaska.html
From the California Dental Association Executive Bulletin, January 12, 2010:
Specifically, ADA granted CDA $200,000 to assist in our effort to prevent the placement of fluoride and its salts on the List of Chemicals Known to the State to Cause Cancer or Reproductive Toxicity that is produced by the State of California, Environmental Protection Agency, Office of Environmental Health Hazard Assessment (OEHHA). The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) requires the governor to publish this list of toxic chemicals each year. OEHHA is currently considering fluoride and its salts for inclusion in the Proposition 65 listing. A determination is expected within the next 13 months.
Sodium and Total Dissolved Solids Increase in Water
After Fluoridation
Metropolitan Water District of San Diego
by Richard Sauerheber, Ph.D.
University of CA, San Diego
Currently Palomar College, San Marcos
In 2007 the Metropolitan Water District of San Diego began injecting industrial grade sodium fluorosilicate into drinking water, allegedly to treat tooth decay. Both sodium and total dissolved solids have steadily increased since that time. The lines in the charts above are computed moving averages.
For every ton of industrial waste fluosilicic acid added to drinking water, another half ton of sodium hydroxide (Drano) must be added to maintain pH at 8.1. Two sodium ions are required to neutralize two H+ ions from H2SiF6.
San Diego gets its water from the Colorado River. Pristine drinking water is low in sodium with levels typically under 10 ppm. The Colorado has natural levels higher than that, but salt levels spiked when The EPA initiated its salt abatement program, which is wrongly named because what it does is allow more salt to be dumped into the Colorado. The EPA allows scores of industries along the Colorado to release one ton of salt a day into the river. Shell Oil is allowed to release 2,000 tons per day from just one of its facilities on the Colorado. This is a particularly stupid policy: Salty water could be released into holding ponds and allowed to evaporate. No significant amount of salt should be allowed deposited into the Colorado.
Fluoridation brings with it even more sodium. Sodium content has risen from below 80 ppm to above 90 ppm since fluoridation began. This additional salt is affecting crop yields and vegetable and fruit quality. For example, avocado production in Southern California is down due to rising sodium levels (North County Times, 2010). When salt reaches around 116 ppm, water is no longer usable to irrigate crops or even grass. Compare ocean water in which the salt level is around 35,000 ppm. Crops need fresh water containing low levels of salt.
Now we are foolishly adding sodium in the form of sodium hydroxide, in order to counter the acidity of the silicofluorides we foolishly add to fight tooth decay. The best research shows fluoride does not protect teeth and instead causes fluorosis of teeth and bones and a host of other problems with organs and systems throughout the body.
The Metropolitan Water District Los Angeles encountered the industrial salt injection problem in 2007, when it started adding 0.1 tons of sodium daily at Lake Skinner alone in the form of sodium hydroxide.
Total dissolved solids (TDS) has also increased since San Diego began fluoridation. The EPA secondary standard for TDS is 500 ppm, and San Diego is exceeding that.
Salinity is a huge problem for agriculture and for human health. Ironically, the EPA has not developed standards for sodium since fresh water has historically been low in sodium. Until recently it has not been a problem. The sodium level in blood is 3,000 ppm but is typically 0-10 ppm in pristine fresh drinking water.
The Vallecitos Water District has raised no objections or questions to MWD on the injections and has ignored public testimony since 2006 opposing the ingestion of the non-FDA-approved fluoride water drug.
Corporate propaganda has turned “fluoride” into a good word. However, the silicofluoride form of fluoride used brings with it lead, arsenic, other heavy metals, and now salt. This is just one of many reasons why fluoridation of drinking water is an unwise policy. If people want to ingest fluoride, they need only swallow some of their toothpaste or mouthwash.
Scientifically yours,
Dr. Richard Sauerheber richsauerheb@hotmail.com Phone: 760-744-2547 Click here to see charts and PFD version.http://fluoride-class-action.com/wp-content/uploads/Sauerheber-on-Sodium-6-4-11.pdf
6-3-11
To Kirk at http://ouramericangeneration.org/:
Fluoride trooper Phil Bradshaw send me this message:
Today I met some college students connecting for social and ecological justice. They are interested in setting up the speaking engagements for Dr. Osmunson, and have the means to connect with all the student groups to set the stage and promote the event. Please send Kirk an invitation to Washington Action for Safe Water at kirk@ouramericangeneration.org. He describes his group as a youth led think tank.
Washington Wafe Water and Fluoride Class Action are interested in involving more people in the effort to get fluoride out of our drinking water. We believe that we would do well to target students because they are filled with idealism and energy and because they are able to comprehend the scientific, environmental, and legal issues involved.
Dr. Bill Osmunson and I are interested in making presentations on campuses. Feel free to call me. Or send me your number and I will call you.
Fluoride has been given a good name through chemical company propaganda, but it is a poison and a toxic waste. Your health will slowly be compromised by the fluoride you take in. Fluoridation is a fraud.
Bill and I recently submitted our work to EPA and HHS – in response to their request for comment regarding reducing fluoride added to drinking water. We believe no fluoride should be added.
See our submissions to EPA and HHS at:
http://fluoridealert.org/re/osmunson.4-19-11.pdf
http://fluoride-class-action.com/hhs/report-card-for-hhs
http://fluoride-class-action.com/hhs/comments-re-lead
The best way to keep up with the fluoridation fight is by subscribing to these Yahoo groups:
FluoridePoisoning-subscribe@yahoogroups.com
Fluoride-Class-Action-subscribe@yahoogroups.com
wa_action_for_safe_water-subscribe@yahoogroups.com
I look forward to talking with you about this effort.
Feel free to forward widely.
Sincerely,
James Robert Deal , Attorney
April 10, 2011
Food and Drug Administration Petition for Reconsideration Docket # FDA 2007-P-0346
To the FDA:
The U.S. Food and Drug Administration is thanked for its long history of not approving fluoride compounds for oral
ingestion for any therapeutic value, defined early-on as use of a drug, not a mineral nutrient.
Recent data confirm that ingested, as opposed to topically applied, calcium-chelating inorganic fluoride ion produces no decrease in teeth cavities (yielding 0.02 parts per million fluoride ion in saliva) but accumulates into bone to thousands of ppm with side effects on calcium homeostasis having no biologic purpose.
All drugs, not just fluorides, ingested in the U.S. require FDA approval, even those in use prior to 1962 (under the FDA Drug Efficacy Study implementation process). Moreover, the Food Drug and Cosmetic Act requires regulation of drugs regardless of their method of dissemination, whether as aerosol sprays in air, as packaged solids, as water-based ingestibles, or any other method. The EPA relinquished any advisory role for water-injected substances used as drugs, and its memorandum of understanding made with the FDA never applied to drugs. FDA action is here requested, either: to ban fluoride compounds from being sold, labeled, or used as anti-caries ingestibles, or to halt such activities during the regulation process, as required by the Food Drug and Cosmetic Act.
The petition request is not known to necessarily reflect the views of the employer of the petitioner.
*****
November 17, 2010
Richard Sauerheber, Ph.D.
Division of Dockets Management
U.S. Food and Drug Administration
Department of Health and Human Services rm 1-23
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Petition for Reconsideration
The undersigned submits this petition, for reconsideration of the decision of the Commissioner of Food and Drugs in Docket FDA-2007-P-0346.
A. Decision Involved. The decision in brief to deny the petition is based on the claim that “the FDA has no authority to ban artificial fluoride compounds used to fluoridate public drinking water”; and that “fluoride in public water supplies is regulated by the U.S. EPA under the Safe Dinking Water Act of 1974 that establishes the current Federal-State arrangement in which states may be delegated primary authority for the drinking water program.”
B. Action Requested. Thank you for the FDA response communicated. Here please examine the corrections rebuttal, necessary because the intent of the petition has been misinterpreted (partly from lack of clarity by the petitioner) and also because incorrect statements were made in the FDA decision response. After reading the entire petition rebuttal here, it should be abundantly clear that all synthetic water-based fluoride compounds, sold and distributed as anti-caries ingestibles, are poisonous substances without any possible caries benefit at the 0.02 ppm fluoride level present in saliva, in contrast to the extremely concentrated artificial fluorides found in toothpastes (1,500 ppm). Inorganic ionic fluoride now plagues the bloodstream of U.S. consumers, to varying degrees, from many commercial bottled waters regulated by the FDA, other beverages, fluoride dental products (responsible for half the blood fluoride in fluoridated cities though the FDA instructs that these not be swallowed), and most U.S. tap water supplies treated with fluoride compounds to elicit claimed effects on human tissue. The indestructible, non-oxidizable, extremely tiny inorganic fluoride ion enters into blood from these materials that are, taken together, responsible for the direct, lifetime permanent accumulation of this agent in the bony tissues of American consumers. The ion is ruled a drug by the FDA when intentionally inserted into water for ingestion (and when in dental topicals) because fluoride is not a mineral nutrient. The fluoride ion has no caloric content and is not a supplement or food, is not a water additive to sanitize water, and pristine fresh drinking waters are devoid of it. Its presence in some water supplies, from natural calcium fluoride, not a registered acute toxic compound as all artificial fluorides are, even then is an undesired aberration which can produce bone abnormality.
This petition requests that the FDA ban fluosilicic acid manufacturers from selling toxic fluosilicic acid H2SiF6 contaminated hazardous waste (as classified by the U.S. EPA) for human ingestion of its fluoride ion, and to ban the re-labeling of the material as ‘fluoride’, and to ban its improper packaging and interstate transport for use as an anti-caries ingestible.
The fact that public tap water is the final vehicle for the dissemination of the agent to fluoridate people, and is responsible for half the fluoride ion present in the bloodstream of consumers in a treated city, has nothing to do with the need for the ban. The ban would apply for the drugs even if disseminated by any other mechanism besides water. Further, it is not simply fluoride marketed as ingestibles for which this petition therefore applies. ALL DRUGS, not just fluoride compounds, are forbidden from public dissemination to treat humans without FDA oversight. This is the law. By coincidence it happens to be fluoride compounds and it happens to be public water supplies that represent the first known violation of Federal drug law with this new loophole. The loophole in Federal drug law must be closed immediately. Failure to do so allows any substance used to treat human tissue to be manufactured to treat U.S. consumers for virtually any condition, as long as it is sold for use via non-traditional media as the end-use vehicle for dissemination. Every proposed medicament in the U.S. must be regulated by the FDA, whether its mass use is by spreading through the air as a spray, or air-dropped as a solid, or by delivering mass packages door-to-door, or any other end-use medium. It is the manufacture, sale, packaging, labeling, false claims promotion, and distribution of drugs, including mostly now these fluoride compounds requiring FDA oversight. Public water is only the first of said non-traditional mechanisms used to treat human beings with unwanted substances that are not FDA approved. The FDA has been tricked for far too long with this first incident, unapproved fluoride ingestibles delivered by enforcement lifetime through public water supplies without informed consent, instead of by directed, consumer-specific, desired and optional consumer purchase and use.
Authority for this request is present in:
1. the U.S. Food Drug & Cosmetic Act which prohibits the sale, interstate transport, manufacture, formulation, packaging, labeling, or use of any synthetic substance for human ingestion without FDA approval (such approval requires controlled clinical trials data and registration submitted to the FDA, as required by FD&CA regulations), regardless of the mechanisms by which the substance is disseminated to the public; and in:
2. the authoritative U.S. Safe Drinking Water Act, which all American citizens, including the FDA, are bound to honor and enforce, which prohibits adding into U.S. drinking water any substance classed as a contaminant by the EPA or that is used as a drug to treat human tissue, particularly if that drug has not been approved for human consumption by the FDA.
Please understand, this petition requests immediate action from the FDA, but not for the protection of public water supplies, as the original petition may have been interpreted, but for the explicit protection of the American consumer.
This petition requests the FDA to protect the public consumer from manufacturers of artificial synthetic fluorides that are misbranded as ‘fluoride’, that are packaged without protection from adulteration, and are transported and sold to other establishments and individuals (some being water districts) without FDA approval, and that are misbranded as having anti-caries benefit (where saliva fluoride levels achieved from fluoride products sold for ingestion are a miniscule 0.02 ppm fluoride) regardless of whether the agents are injected into water or are dispensed as consumables by any other method. These activities must be halted by the FDA until controlled human clinical trials are completed that establish safety and effectiveness of synthetic fluorides for oral ingestion, as required by the Food Drug and Cosmetic Act and stipulated in the Code of Federal Regulations, for any new drug substance proposed to be used to treat human tissue in the United States.
All Food Drug and Cosmetic Act CFR 21 regulations for new drug application, registration, labeling and packaging requirements must be met by any manufacturer and by any synthetic product, including hazardous waste fluosilicic acid, before approval by the FDA for human consumption. These conditions must be completed prior to sale of said material in either concentrated or diluted form for human ingestion in any oral consumable. FDA has full rights also to ban all substances used as drugs to treat human tissue fluoride compound additions into public tap and bottled water, not because FDA regulation of tap water is necessarily its specific authority per se, but because regulation and monitoring of safety and effectiveness of ALL drugs, and the use of any non-FDA-approved substance for human ingestion as though a drug, experimental or otherwise, are the SOLE authority of the U.S. FDA.
Finally, the current conflicting CFR 21 regulations on fluoride use (in bottled water verses fluoride topical products that are requested not to be used in cities having their water treated with fluorides) must be corrected. If fluoridated tap water is not banned or temporarily halted, the best method would be to delete the CFR regulation allowing ‘fluoride’ from unspecified sources to be directly added into bottled water, since consumption of bottled water fluoride compares to that from fluoride tap water, both producing miniscule fluoride levels in saliva having no anti-caries benefit (for which fluorides are added), while at the same time leading to permanent, irreversible pathological abnormal accumulation of the fluoride ion into bone, forming precipitates that force abnormal bone matrix formation to help minimize the altered calcium homeostasis. The request for an outright ban is driven by the facts gleaned from massive data sets proving that there is no dose of ingested fluoride at which dental caries effects can occur, where all doses are accompanied with the adverse permanent pathologic accumulation into bone. Toothpaste use and fluoride bottled water use is simple for any fluoride-sensitive person, or rational person adept at good dental hygiene, to avoid. Tap water fluoride however is not avoidable since the tiny ion cannot be filtered and requires special expensive procedures to remove.
The intentional treatment of U.S. consumers with artificial synthetic fluoride compounds, falsely represented by manufacturers, packagers and distributors as anti-caries ingestibles without FDA approval, is in strict violation of the Food Drug and Cosmetic Act. Manufacturers of synthetic fluoride compounds, whether sold for ingestion in bottled water, public tap water or instead to other establishments to formulate the agent for human consumption, requires FDA approval from controlled clinical trials data for new drugs, registration of facilities, and the materials must meet standards for purity, quality, and labeling, as clearly stipulated in the Code of Federal Regulations for any new drug, independent of dissemination method.
Although artificial inorganic synthetic fluoride compounds are now the most consumed substance used as a drug to treat human tissues in the country, no Federal agency regulates the manufacture, labeling, packaging, transport, distribution, or dosage instructions, or monitors the substances for purity, safety, effectiveness, side effects, or chronic long-term adverse health effects that have now been documented to widely occur. The Environmental Protection Agency, recognizing that water-injected fluorides are not accidental “contaminants” the EPA is authorized to regulate, long ago relinquished regulatory authority and liability and certification for intentionally injected fluorides to the National Sanitation Foundation as a possible “water additive.” The NSF in turn recognized fluorides are not additives that sanitize water, as chlorine and other additives do, and defers authority for safety, purity and effectiveness of fluoride compounds to the U.S. Centers for Disease Control. The CDC promotes fluoride consumption for teeth caries reduction without labeling them drugs, contaminants, additives or water ingredients (since most pristine fresh drinking waters are devoid of fluoride), as though fluorides are ‘supplements’ that affect teeth tissue. The CDC however admits no authority to enforce its use nor does it certify safety for continuous long-term fluoride consumption, nor accepts liability, nor has regulatory authority over supplements, which is the sole purview of the U.S. FDA. The FDA assigns a maximum level for fluoride in bottled water but claims no regulatory authority over substances in tap water, and defers authority to the EPA that regulates contaminants. The EPA notes however that contaminants are accidental, unwanted materials such as pesticides and refuses to accept regulatory authority for intentionally injected fluoride compounds, and the completed circle has no end.
Specifically confirming this un-regulated circle (see three accompanying letters), look no further than the greater Los Angeles, California region serving over 12 million souls with fluoride drugs that are not FDA approved that are purchased from manufacturers that are not FDA registered/permitted. The President of the massive Metropolitan Water District answered my query on fluoride safety, writing that “We rely on the Department of Public Health [under the CDC] as the primary regulatory agency on drinking water safety.” In dramatic contrast to this however, notice the response for that query from the said Department of Public Health, who wrote that the “Department of Public Health does not have authority to intercede with the Metropolitan Water District of Southern California decisions to utilize fluosilicic acid for the implementation of community water fluoridation at its five treatment plants.” This statement also compares to sentiments written to me from the U.S. EPA, that water fluoridation is a ”States’ rights” and local water district issue that the EPA has no authority to regulate for either safety or effectiveness. This is because it is an intentional drug substance that only FDA can regulate.
No Federal agency maintains or even accepts regulatory authority or any liability or responsibility for the most widely consumed ingestible substance in the United States for its claimed anti-caries use. No manufacturer, labeler, packager, transporter or distributor is being fined or reprimanded in any way for the intentional use of fluorides as oral ingestibles, usually through public waters, including tap water and FDA-regulated bottled water, even though: 1) such oral use for synthetic fluorides violates the Food Drug & Cosmetic Act having no FDA approval for ingestion, and even though: 2) any injections into public drinking water of either drugs or contaminants are strictly prohibited by the Safe Drinking Water Act.
Sadly, several false statements have been provided to the U.S. EPA and to the U.S. FDA that have had illegal undue influence for un-natural synthetic fluoride compounds, as though they are desired ingestibles when instead all have no nutritive value and are toxic compounds. These statements (listed in the attachments) have misled both agencies to avoid, by special consideration, the Safe Drinking Water Act and the Food Drug and Cosmetic Act, thereby allowing such treatment of the U.S. population to fluoridate blood in a mass program with a diluted bone-accumulating compound. Mass ingestion of synthetic fluoride compounds, claimed to be a water-based anti-caries oral treatment, has been promoted with these anecdotal and misleading statements that are in strict violation of drug labeling and clinical trials data requirements outlined in FDA CFR 21. Such materials also require manufacturer facilities registration and require prescriptions for use by individuals, rather than a permanent dose in perpetuity for every person in the country, even those sick, even those without cavities or any such need.
Synthetic fluorides lack calcium, and thus all have acute lethal doses comparable to that of arsenic compounds in tested animals, and all are assimilated substantially more readily after ingestion than natural calcium fluoride. Synthetic fluorides are cumulative, permanent toxics lifetime (even natural calcium fluoride also is known to debilitate lifetime but at higher doses). The synthetic materials are now ingested in uncontrolled total dosages, in the complete absence of any important health concern, without cause, by vast millions of Americans. The influential statements mentioned above were not statements of fact, had no supporting scientific data as basis, and are instead mere verbal endorsements (see attachments from FDA CFR records).
It must be noted and acknowledged that, Nobly, the U.S. Food and Drug Administration officially and properly ruled in 1963 that such a synthetic fluoride water-based program of treatment of people constitutes “an uncontrolled use of a drug” (see enclosed FDA letter), where total dosage would be impossible to regulate, and the infirmed and susceptible, unable to process the ingested material, are not identified. Such a declaration would also be made for any drug, not simply fluorides, administered this way, and also for any drug administered without FDA approval through the air, or other mechanism of dissemination, regardless of the fact that EPA is in charge of regulating accidental contaminants in the environment.
Further, artificial fluoride has not been given FDA approval for oral ingestion in spite of a CFR 21 statement allowing ‘fluoride’ be added to bottled water. “Fluoride” is not a legal or chemical definition of any known specific tangible substance, because the ion only exists in combination with other ions. The statement that “fluoride can be added” to bottled water in FDA CFR regulations thus has no meaning and was made by individual(s) with junior understanding of the chemistry of the fluoride ion. Sadly, this statement has undoubtedly been extended to imply tacit approval for synthetic fluoride compounds including fluosilicic acid to be injected into tap water and thus into bottled water. Fluosilicic acid H2SiF6 is source material for some bottled fluoride water and is not sodium fluoride NaF and requires its own clinical trials data demonstrating safety and effectiveness for FDA approval for oral ingestion according to CFR regulations. Moreover, the statements by endorsement rather than with scientific data attempt to reverse FDA long-held policy that fluoride not be mentioned as a water ingredient, or be labeled by content or amount in bottled water, so as to prevent any mistaken suggestion that fluoride might be a normal or allowed ingredient. Intentional lack of fluoride labeling in bottled water was suggested to discourage fluoride compounds of any kind from being added intentionally into water as though it is either a desired or a normal water ingredient (see attached letter from National Soft Drink Asso.), when in fact its presence is an aberration that is regulated as a contaminant.
The meaningless statement to ‘add fluoride’ into bottled water for human ingestion, recorded in the Federal Register, must be clarified or deleted because:
1) “fluoride” as a single entity cannot be exclusively added to water. The statement has no actionable meaning or use, other than to be misinterpreted by the unethical that has led to the intentional addition of artificial fluosilicic acid, for its fluoride, into public tap and bottled waters, as though this were an FDA approved acceptable anti-caries practice, when it is permanent dosing in perpetuity of the American public with the toxic, cumulative inorganic fluoride ion without ensuring that adequate calcium is present to check its assimilation; and
2) the ruling contradicts CFR 21 section 355 regulations for fluoride-containing dental caries products that are to be avoided by consumers living in fluoridated water regions. There is no statements made for using such products while regularly consuming 1 ppm bottled fluoride water.
FDA regulations for fluoride drugs are therefore currently self-contradictory and require correction. FDA CFR regulations for ingestible bottled “fluoride water” are incompatible with FDA regulations stipulating use of fluoride oral topicals in non-fluoridated water regions. That is, no recommendation is made on bottled fluoride water to avoid oral fluoride topical drugs while consuming the bottled water. And no labeling is required on oral fluoride topical drug products to avoid consumption of bottled fluoride water.
Most important to understand is that, unlike toothpaste fluoride-enriched drug products, any claim of effectiveness for fluoride as an anti-caries ingestible from a water-based product constitutes misbranding of a drug. This is so, whether such claim is made by bottled fluoride water manufacturers (fluoride is only added for presumed anti-caries benefit) that the FDA regulates, or for fluoride-ingested tap water:
1) Biochemical measurements (NRC, 2006) prove that fluoride levels in saliva are a miniscule 0.02 ppm during continuous consumption of 1 ppm fluoride water, a level so low as to be unable to induce anti-caries benefit of any kind, in spite of sweeping, zealous claims from dental officials that still presume fluoride from orally ingested fluoride water (whether bottled or tap) exert caries benefit systemically from blood into enamel during growth and from saliva topically (see Pollick comments attached), even though the CDC has changed its position and admits that fluoride only acts topically (e.g. from toothpaste at 1,500 ppm) (Thiessen; Connett, see attachments).
2) Any allowance by the FDA of intentional ingestion of artificial synthetic fluoride compounds for any biologic purpose is without merit, since neither NaF nor H2SiF6 are FDA approved for human ingestion and lack controlled clinical trials (Connett attached).
3) Any fluoride dose sufficient to alter teeth tissue from blood (i.e. incorporation into teeth dentyne interiors or developing enamel) also causes pathologic accumulation of fluoride into bone (Thiessen attached)—there is no way to separate adverse effects from effects on dental tissue (Thiessen, see attachment).
Artificial water fluoridation is a mass treatment program with an ingredient that is not present in pristine natural drinking water and that is purchased from manufacturers that have no FDA approval or FDA registration of facilities. Moreover, every U.S. citizen, including the FDA, is expected to follow and honor the Safe Drinking Water Act and to enforce it. Any citizen witnessing an individual or agency dumping substances into public waters that do not belong there must report such violations and do their part for enforcement. Such is the rationale for this petition, explaining how artificial fluorides are manufactured, improperly packaged and improperly labeled and sold for ingestion without approval and are routinely even injected into public water. The SDWA prohibits such injections whether contaminants or drugs, regardless of whether the EPA MCL is exceeded or not. And the FD&C Act prohibits treating any human with a synthetic drug that is not FDA approved, where the method of dissemination is irrelevant.
The EPA is a house divided on water-injected fluoride. Injection of any drug or any contaminant into public drinking water, including un-natural synthetic toxic fluoride compounds, is strictly forbidden by the SDWA, whether or not the final levels of fluoride and its associated contaminants from fluosilicic acid hazardous waste are present in the water below their EPA MCL. Although fluoride is recognized by the EPA as a contaminant, water injections are allowed by the EPA because the intended use is not to poison but to treat human tissue, which has confused the EPA and resulted in an internal self-injunction (Connett, P., Beck, J., and Micklem, H., ”The Case Against Fluoride”, Chelsea Green Publishing, White River Junction, Vermont, 2010). Fluoride ingestibles added intentionally to fight cavities are indeed drugs, and the EPA currently gives such regulatory authority to individual States, since the EPA has no authority to monitor side effects or safety or effectiveness of drugs. The EPA could ban all injections under the SDWA, but thus far has been unable to do so. The previously submitted list of professionals who demand an end to the fluoridation of the American consumer includes these EPA scientists.
The FDA must also honor, as does any U.S. citizen, the SDWA to help protect water supplies from corruption with fluoride compounds, in particular artificial synthetic toxic fluorides, or any drug or contaminant. Synthetic chemicals to treat humans by ingestion used in public waters are now mostly manufactured without FDA approval from facilities that are not registered with the FDA. In gross violation of the Food Drug and Cosmetic Act, fluosilicic acid mixtures are re-labeled as ’fluoride’ and sold for human ingestion as anti-caries water-based ingestibles. FDA already recommends avoiding use of various concentrated fluorides in toothpastes, dental gels, and rinses by those residing in cities that have fluoride-drugged water, as listed in CFR 21, Chapter 1 Subchapter D Part 355:
“Adults and children over 6 may wish to use this extra-strength fluoride dentifrice IF they reside in a NON-FLUORIDATED area [or if they have a greater tendency to develop cavities].”
Fluorides in tap water could be banned to prevent this FDA adjustment because they are being used as drugs. But even more importantly, manufacturers of fluosilicic acid sold for anti-caries benefit to either water districts or other establishments require full FDA regulation before such sale even occurs. Sodium fluoride purity and concentration are strictly regulated by the FDA for oral dental products in CFR 21, and sodium fluoride is wisely not FDA approved for human ingestion, where it is stated that children are to be instructed not to swallow these oral drug products (Part 355). This is most fortunate, since we now know that half of the fluoride ion in the bloodstream of consumers in fluoridated cities comes from toothpaste, and the other half comes from the fluoride-drugged water (National Research Council Report on Fluoride in Drinking Water, Chapter 2, 2006, National Academy of Science, Washington, D.C.). Only the toothpaste half is thus far chosen for FDA regulation of the fluoride drug, but all ingested fluorides are under the purview of the FDA because fluoride is a drug, independent of the method by which manufacturers incorporate the synthetic material into the consumer.
No ban from consumption is here requested against the presence of calcium fluoride in any water supply below the 2 ppm EPA SMCL that may occur naturally, where natural calcium fluoride is not a listed acute toxic, having a lethal acute experimental dose of 5,000 ppm—even though long-term toxicity is also known even for natural calcium fluoride. When present naturally, rather than intentionally as a drug, the FDA would not be regarded as in charge of such regulation. The FDA petition addresses the intentional injection of fluoride compounds to treat people, where all synthetics have acute lethal toxicity comparable to arsenic compounds at 125 ppm, for which 1 ppm in water base only provides margin of safety against an absurd lethal endpoint. Chronic pathology induced by artificial fluorides during continuous long-term consumption is not currently addressed by either the FDA or the EPA. The current use of artificial fluoride compounds at 1 ppm produces continuous blood levels of 0.21 ppm fluoride ion, that is not in keeping with protection of the health of the American consumer, the essential mission of the U.S. FDA, all of which could be remedied by halting manufacturers of fluosilicic acid and any synthetic fluorides intended for ingestion, and/or insisting clinical trials data for safety and effectiveness, and registration of facilities, be submitted to the FDA.
No public health interest is at risk if this petition is honored, because all cities that have voluntarily stopped artificial fluoride water injections report no increase in caries rates, and no evidence of caries reduction benefit has ever been found in carefully controlled studies in either man or animals in the first place, and the fluoride toxicology expert panel of the National Research Council published in 2006 that the current allowed level of fluoride in drinking water IS NOT PROTECTIVE OF HUMAN HEALTH (Connett,et.al., ibid; the taxpayer-funded massive study by the National Institute of Dental Research, reviewed in: Chemical & Engineering News, May 8, 1989; National Research Council,2006; Yiamouyiannis, Fluoride the Aging Factor, Health Action Press, 1978).
Full grounds for the petition request are enclosed. It is asked that the truth on this issue be sought and found so that a proper determination can be made for the long-term welfare of the people we serve.
Sincerely,
Richard Sauerheber, Ph.D., University of California, San Diego
currently Palomar College, San Marcos, California
(printed and signed November 17, 2010)
Points Established in this Rebuttal. After examining the data presented here in its entirety, the following key facts will be made known to the U.S. FDA that will require FDA action:
1. Artificial fluoride compounds, mostly sodium fluoride and crude hazardous waste with fluosilicic acid as chief ingredient, are manufactured without registration of facilities or submitting clinical trials data. The agents are sold as key ingredients to be ingested, usually as water-based agents, that are professed to have anti-caries benefit (see point #6). All synthetic un-natural fluoride compounds are poisonous calcium chelators, while natural calcium fluoride is a less toxic compound. The impure fluosilicic acid, classed by the EPA as a toxic hazardous waste, is packaged, re-labeled as ‘fluoride’, transported in containers that are not tamper-proof to prevent adulteration prior to delivery as required by the Food Drug and Cosmetic Act, and are sold for wide public consumption in violation of strict regulations in the Safe Drinking Water Act and the Food Drug and Cosmetic Act. Both ingredients are intentionally injected into most U.S. tap water supplies, and thus both supply fluoride ion in bottled fluoride waters marketed in the U.S. that FDA regulates.
2. Artificial fluoride compounds that are manufactured for the purpose of human ingestion, including those injected into public bottled or tap water supplies, are drugs, as defined scientifically, medically and legally. Fluoride compounds have zero calories and are not foods; are not mineral nutrients (see attached FDA letter) and thus are not supplements; are not additives that sanitize water; and are not normal water ingredients, but are intentionally added for use as anti-caries drugs. Pristine fresh U.S. drinking waters are devoid of fluoride, and the historical and current use of synthetic fluoride injectables is not to treat water supplies with an ingredient, but instead to elevate the blood of the consumer to 0.21 ppm fluoride ion for the specific, express, exclusive purpose of the purported effects of the blood-borne ion on human tissue.
3. All synthetic fluoride compounds, including fluosilicic acid and sodium fluoride, whether placed into bottled water, toothpaste, tap water or other materials used as anti-caries drugs are under the legal purview of the U.S. FDA for the manufacture, labeling, packaging, transport, composition, purity, strength, establishment of safety and effectiveness, and regulation of dosage and methods of use. Federal drug laws that are now violated, for artificial fluoride compounds marketed as anti-caries agents for internal human ingestion, are egregious. A partial list of violations is in the appendix for the agents during manufacture, labeling and transport, long before endpoint of use, all which require FDA regulation.
4. The Safe Drinking Water Act forbids injecting into public waters any drugs or contaminants, including fluosilicic acid or sodium fluoride, either as anti-caries intentional drugs OR as accidental contaminants, regardless of whether the final diluted level may be below an EPA MCL. This prohibition exists independent of pre-existing levels for such materials already in the treated water. The Food Drug and Cosmetic act prohibits manufacture or sale of drugs, or use of any synthetics such as these artificial fluoride compounds, for human ingestion, either directly by prescription or indirectly through addition into water, without human clinical trials data, and without FDA approval.
5. The FDA has no Congressional or other authority to transfer regulatory roles for drugs in the U.S. to the EPA. Thus, the FDA is currently not in compliance with the FD&C Act or the SDWA for artificial fluoride compounds, either sodium fluoride or diluted crude hazardous waste fluosilicic acid, which are intentionally injected as drugs into public waters, both in tap water and accidentally (or perhaps by intent) into FDA-regulated bottled fluoride water. Fluoride ion from synthetic compounds, which is indestructible and smaller than the water molecule and cannot be simply filtered, is found in bottled water made from municipal tap water. Because synthetic fluorides reside in tap water before bottling, and because CFR 21 contains an easily misinterpreted statement that “fluoride [unidentified form] may be added to bottled water”, tacit approval has been, either by accident or intent, conferred for synthetic fluorides in drinking water, as though water is, and may be used as though it were, an anti-caries beverage. The FDA has Nobly never approved artificial fluoride compounds for intentional human ingestion, because controlled clinical trials data do not exist. EPA regulates artificial and natural fluorides as contaminants when accidentally present in public tap water, but the EPA does not regulate any fluorides when intentionally injected into water as anti-caries drugs which this petition addresses, nor does Congress authorize the EPA to conduct such monitoring or regulation of drugs.
6. No fluoride ion, from either synthetic or natural sources, in either tap or bottled water, exerts useful topical effects on teeth structure or decreases teeth caries, where ingested fluoride levels are miniscule in saliva (0.02 ppm) and blood compared to levels of artificial fluorides in toothpaste (1,500 ppm) and mouthwashes (150 ppm) that are now regulated by the FDA for anti-caries purposes. Instead, the average 0.21 ppm fluoride ion in consumer blood from fluoridated water accumulates the ion in an abnormal process permanently into bone and also into brain tissue with associated documented adverse pathology.
7. The U.S. FDA is currently non-compliant with requirements of the Food Drug & Cosmetic Act for fluoride compounds marketed as anti-caries ingestibles. Fluosilicic acid manufacturers have not registered with, nor provided clinical trials data for, either safety or effectiveness for use of crude hazardous waste H2SiF6 in diluted form as a water-based anti-caries agent. This material is transported illegally, for purposes of human ingestion as the chief ingredient of a purported anti caries water-based ingestible, by railcar or truck to various states that is now injected into 65% of U.S. tap water supplies, and thus also into some bottled fluoride water and other ingested U.S. products. Because no Federal agency monitors such fluoride injections into public tap water, this hazardous waste material is poised for use in the future, if not already, as an intentional direct additive into bottled water or into toothpastes, mouthwashes, dental gels or powders, or other possible products for the fluoride ion it contains, all without FDA approval and without approval for ingestion.
8. It is not possible for the U.S. E.P.A. to monitor fluorides when used as drugs, for purity, side effects, effectiveness or chronic adverse health effects–the EPA regulates accidental water contaminants. The 1979 FDA-EPA Memorandum Of Understanding did not apply to drugs, and the FDA never intended to relinquish in any such agreement any oversight for drugs, regardless if injected into tap water or other environmental source. The agreement has been invalidated for many years for fluoride, with the rejection by the EPA of any responsibility for fluoride tap water injectables, now recognized as being not accidental contaminants or water treatment additives, but agents injected for putative anti- caries benefit. The EPA is a house divided, and has not resolved its own injunction against itself regarding fluoride injections, that violate the SDWA and are ineffective and exert adverse health effects. The EPA asked the NRC to review water fluorides but has refused to follow NRC requests to lower the MCL for fluoride, as it is not protective of human health at 2 ppm and is nevertheless being allowed in tap water at far higher levels than the normal factor of 100 margin of safety to prevent such adverse effects. Toothpaste fluorides (1,500 ppm not permitted to be ingested) and bottled fluoride water (less than 1 ppm which are proven ineffective as anti-caries medicaments, both in large population studies and by direct biochemical measurement) have been ruled by the FDA to be FDA-regulated. Manufacturers of drugs are also FDA, not EPA, regulated, regardless of method of dissemination into consumers. Regulation of drugs is simply the sole purview of the U.S. FDA, whether consumers are treated through topical pastes and rinses, by inhalation of drugs through the air, or by ingestion in water, etc.
9. It is necessary for the FDA to ban all artificial fluoride manufacturers that sell products for human ingestion without FDA approval. FDA must regulate establishments that manufacture, package and re-label fluosilicic acid as ‘fluoride’ that is sold for anti-caries use as ingestibles. FDA must regulate establishments that formulate final mixtures used for human consumption of artificial synthetic fluorides. These actions are required to defend regulations for drug products in the Food Drug and Cosmetic Act, in addition to those in the Safe Drinking Water Act. Absence of a ban has led, unintentionally on the part of the FDA, to use of toxic hazardous waste fluosilicic acid in tap and bottled water, and can lead to its widespread direct addition of this or sodium fluoride into water-based beverages, where long-term consumption accumulates fluoride ion into bone, brain, and other tissues permanently lifetime. These materials may also be thus used in future unknown products sold for either topical application or by direct ingestion as sprays, etc. Relevant comments on bottled fluoride water are provided.
10. While statements are made of safety and effectiveness of synthetic inorganic fluoride compounds lacking calcium (which are mere, unscientific endorsements without controlled clinical trials data), children have been killed by heart attack from swallowed fluoride gels in dental chairs, 300 people were poisoned from 1 ppm fluoride water during an overfeed with one fatality with heart attack, broad adverse health effects accumulate in the U.S. widely as documented by the panel of experts in the National Research Council Report on Fluoride in Drinking Water, 2006 with vast data relevant to both bottled fluoride water and fluoride tap water, and tooth fluorosis is now endemic in the U.S. in cities that both fluoride-drug water supplies while also using fluoride toothpaste, gels, mouth rinses and other fluoride products (see statements from Colgate Palmolive and CFR statements not to use fluoride topicals in fluoridated water regions). While synthetic fluoride in toothpaste and other products is argued as “an effective decay preventative dentifrice”, it is important to note that even a hammer can also similarly be labeled. Hammering out a tooth prevents it from developing cavities, and fluoride tap water in the test city of Newburgh, New York caused delayed teeth eruption, where missing teeth were considered ‘absence of cavities’. “Water fluoridation” is not a great health achievement of the 20th century, when people are allergic to synthetic fluoride, and which has widely sickened and has killed. Ascribing to fluoride the teeth benefit that actually comes from calcium, in natural calcium hard water which can contain some calcium fluoride, is responsible for current misconceptions of dental officials in the Oral Health Division inside the Centers for Disease Control. This perception has deceived the U.S. Congress, most U.S. water districts, the EPA, and the general public. Ironically, a hammer would be preferred over artificial fluoride injections for caries reduction in children, because the patient at least would not be harmed from any blood-borne fluoride insecticide/rodenticide which produces its cumulative toxic effects during lifetime consumption that have been known, understood and published by toxicologists since 1939.
Salient Points Summarizing Original Petition
Unnatural, synthetic fluosilicic acid, collected from pollution scrubbers of phosphate fertilizer industrial plants, is now re-labeled as ‘fluoride’, transported and sold in order to electronically infuse into 65% of all U.S. public water supplies to treat dental caries through ingestion. The toxic hazardous waste is packaged and shipped by truck and railcar in rubber-lined tanks (since fluosilicic acid readily dissolves stainless steel, glass, concrete and other metals) and sold as ‘fluoride’ to water districts for the injections. Although the CDC originally described for this purpose use of natural calcium fluoride, which is not a listed toxic on any poisons registry because calcium is the antidote to fluoride poisoning, fluosilicic acid, and sodium fluoride before that, as calcium chelating metabolic poisons, are listed as toxics in all poisons registries with a lethal dose comparable to arsenic and lead in acute animal testing.
Claims are made that these artificial fluorides are as “safe and natural” as natural calcium fluoride, which convinces manufacturers, distributors, and end-users to use this ingredient to treat human tissues through oral ingestion. The ratio of calcium to fluoride, the key factor determining fluoride ion toxicity, is massively decreased by the artificial fluoride injections, causing the fluoride ion after ingestion to be more readily assimilated into the bloodstream. The CDC and ADA now admit that blood fluoride cannot improve teeth health systemically, and that any such effect by fluoride is by topical application only (Connett, ibid). This is why toothpaste and mouth rinses contain synthetic fluoride, but at 1,500 ppm as regulated by the FDA, that inhibits bacterial growth and can exert teeth effect. Water-based fluoride at only 1 ppm, with the associated blood and saliva (0.02 ppm) levels being miniscule, is unable to elicit any such purported, untested and unproved effect on teeth. Teeth enamel in fact is a perfectly crystalline hard structure that forms in the original enamelization process in children only in the absence of significant fluoride. Fluoride from blood during enamel growth, depending on water hardness, only causes varying degrees of enamel fluorosis, abnormal enamel that is the first visible sign of fluoride poisoning from fluoride overdose. All artificial injected cities have substantial increased incidence of tooth fluorosis without exception, proving that the act of fluoride treatment of water supplies, as an anti-caries rinse or anti-caries ingestible, itself represents overdose of a drug.
After long-term continuous consumption at 4 ppm fluoride water, plus toothpaste use of course, bone fluoride reaches massive levels in elderly people up to 12,000 ppm in some cases. This causes bone pain and actual immobility. Lower levels in bone from 2 ppm water fluoride typically cause arthritis-like bone and joint pain and weakening of bone, more subject to fracture.
At 1 ppm water fluoride, as currently allowed by the FDA for bottled water, after only 2 years, bone accumulates an average 2,000 ppm fluoride, with variability depending on water hardness of course. Bone fluoride accumulation cannot be reversed, even after transfer to fresh water cities for 25 years (NRC, 2006). In the original test city of Newburgh, N.Y. there were substantial increases in incidence of bone cortical defects that were detected by X-ray. Lifetime drinking 1 ppm approaches 4,000 ppm in bone with significant weakening of bone. This is a pathologic, not a physiologic, effect, where dose response curves are actually linear and non-saturable and irreversible, permanent! Incredibly, on interview these victims of fluoride poisoning often claim that it must not be the ingested fluoride that is responsible, because “I’ve been drinking fluoride water all my life, so it can’t be that” (Bryson, ibid). This phenomenon is also in current operation when it comes to toxic fluorides used in toothpastes and dental gels. Used now for many decades, the presumption is that it must be of benefit and must be harmless, all while the fluoride ion as an insidious toxic inorganic ion accumulates from assimilation over lifetime use.
Continuous long-term consumption of approximately 1 ppm fluoride in water also can cause significant anemia and incorporates into calcium rich regions of brain tissue and is now known beyond reasonable doubt to be able to lower IQ in children raised on such water. 23 studies have now been published from reliable medical institutions, many of which are available for examination at www.fluoridealert.org. The American Dental Association now recommends regular water without added fluoride be used for infant formula and the FDA recently followed suit, forbidding fluoride exposure in infants from any FDA regulated material, and particularly in a fluoride water city. This is because fluoride assimilation rates are so excessive in infants at this age. Finally, fluoride interacts with aluminum ion, forming complexes that are more readily assimilated after ingestion. This causes enhanced uptake of aluminum, when also present in either water or the diet together with fluoride, into brain protein tangles of Alzheimer’s disease victims, complicating this widespread condition.
It is astounding that laws are being overlooked intentionally to accommodate this useless, harmful and expensive procedure. It is a violation of the Food Drug and Cosmetic Act to produce, formulate, sell, repackage or re-label any synthetic artificial chemical for human ingestion without FDA approval after submission of human controlled prospective clinical trials data for safety and effectiveness. These have not been submitted, for either sodium fluoride first used in 1945 or for fluosilicic acid which came to be used, also without FDA approval, many decades later. It is unlawful to manufacture, to re-label or to transport across state lines any chemical agent formulated with intent for human ingestion that is not FDA approved, and from any establishment that has not obtained permits from the FDA as required by the Food Drug and Cosmetic Act. Most important, it is a violation of Federal drug law to treat any person with any proposed medicament without their informed consent, and far more often than not when informed on this issue, people vote against these injections, and yet artificial fluorides are the most widely abused ingested chemicals in the United States. The states of Oregon and Nebraska by legislation and by vote, respectively have banned fluoride treated water supplies.
In short, all fluoride compounds used as anti-caries treatments as ingestibles (whether water-based or by direct ingestion of any other fluoride product) are ineffective and harmful. Establishments that manufacture and distribute such materials for human ingestion are subject to Federal law which each violates. In defense of the Food Drug and Cosmetic Act and the Safe Drinking Water Act, it is necessary for the FDA to take action on such establishments to prevent oral ingestion of toxic artificial synthetic fluoride compounds which are not FDA approved for human ingestion, and which lack human clinical trials data. Various options for FDA action are requested in this rebuttal, listed in decreasing order of importance desired by citizens of these United States whom the petition defends. These points from the original petition and more are now very readably described in the new textbook by Connett, P., Beck, J., and Micklen, H., ”The Case Against Fluoride”(ibid).
Following guidelines carefully, stipulated in 21CFR 10.33, petitioner here submits a request to the Commissioner for review of the above petition. Several concepts were not fully understood and adequately considered in proper context, and are here clarified. In defense of the long-term health of U.S. citizens, it is essential to understand the significance of artificial fluoride compounds used as anti-caries treatment products, which are now marketed as ingestibles, and which as a result are being injected into public tap and bottled water supplies to treat caries in humans, while having no controlled human clinical trials data submitted to either the U.S. FDA (or the U.S. EPA) as required in FDA CFR 21 (see attachments). FDA CFR 21 regulations specifically mandate requirements for strength, purity, testing for effectiveness, labeling, and dosage descriptions for fluoride anti-caries products manufactured, sold OR used in the United States.
As of now, fluosilicic acid for anti-caries use is manufactured and distributed by establishments without application for registration with any Federal agency. Some of these establishments are foreign and some domestic, all in violation of long-standing regulations stipulated in the Food Drug and Cosmetic Act (Connett, ibid, see attachment). All fluoride anti-caries drugs are regulated by the U.S. FDA and all are not approved for injection into public water supplies for human consumption, regardless of dilution employed. Whether used as drugs to treat tissue, or whether considered as contaminants, using water as the mechanism of disbursement of either are also prohibited by the Safe Drinking Water Act. The EPA is subject to the SDWA for contaminants, and the FDA is subject to those provisions in the SDWA for drugs (legal brief excerpts attached from Osmunson and Deal). In the case of synthetic fluorides, which can be accidentally spilled during transport, mixing with caustic soda and distribution into public water supplies, as a contaminant, or when titrated at a pre-set concentration to elicit effects on humans as a medicament in water, or as additives in toothpaste or in bottled water, or other method of dissemination of this (or any) drug, there is no duplication of services by EPA and FDA since neither are in charge of each others’ responsibilities. EPA currently is unable to police its own compliance with the SDWA regarding fluoride as a contaminant (now defined as such in EPA records currently available for public review) and has not resolved its own internal injunction against fluoride allowances (Connett, p. 208), in spite of the conclusion that EPA-allowed levels of fluoride in water are not protecting human health that was forwarded to the EPA from the National Research Council in 2006. The NRC detailed, taxpayer-funded study was conducted by a large panel of experts on fluoride toxicology of published data from cities with water fluoride ranging from control levels, to 1-4 ppm fluoride that fully applies to water fluoridation programs and fluoride in bottled water, where consumers in fluoride drugged cities, as for most cities in America, typically also use fluoride toothpastes, fluoride bottled water and may consume other fluoride sources.
The great gamble of the original Public Health Service in 1950 has been proven with zero doubt to be a failure on both counts. Artificial fluorides that have no FDA approval for human ingestion, used as a mass medicament (Buck, “The Grim Truth About Fluoridation”, 1963, see original petition) in water that enters blood and saliva, is unable to improve teeth health, ranging from only 0.02 ppm in saliva to 1 ppm in the ingested treated water (National Research Council, 2006) and instead have produced a plethora of adverse health effects, now widespread and fully documented, with mass accumulation of fluoride ion into bone in a pathologic, linear, non-saturable, irreversible permanent process that contributes to the U.S. current epidemic of hip fractures in the elderly (see petition). The view of many experts remains correct, that injections of this contaminant must be held at zero and have of course always been in strict violation of the U.S. Safe Drinking Water Act, which absolutely forbids the INTENTIONAL injection into water of any contaminant AND forbids the use of public water supplies as a vehicle for the injection of any chemical used as a medicament drug to treat human tissue. The EPA is not compliant with these requirements of the SDWA for fluoride compounds, allowing exception to the traditional margin of safety of 10 to 100 times below the lowest level known to cause adverse health effects for contaminants, for the sole purpose of protecting the fluoridation program, as written in EPA’s own words (Connett, ibid, p. 206).
As well, the FDA currently remains in noncompliance with the SDWA drug restriction provisions for chemicals added to public water supplies for purposes of treating tissue, which defines such chemicals as drugs that are under FDA purview. The SDWA applies both to the EPA and to the FDA and in fact must be followed by every citizen of the United States. Currently regulated fluoride anti-caries dental products, such as sodium fluoride, stannous fluoride and other fluoride compounds regulated by the FDA, are not permitted to be intentionally ingested. The FDA is currently not in compliance with either the SDWA or the FD&CA and its CFR regarding sodium fluoride or other anti-caries fluorides manufactured and marketed for human ingestion, particularly those used in public tap water injections.
Bottled water that may contain fluorides are regulated by the FDA, as stated in the response. Any such water that is filtered from fluoridated public water supplies would be marketed in violation of the goals of the Safe Drinking Water Act if it contains injected toxics from fluosilicic acid preparations now commonly used for public water supplies. Any re-labeling of such water as ‘fluoride water’ or water with fluoride would constitute false labeling of chemicals, since fluosilicic acid H2SiF6 always contains variable amounts of arsenic and unidentified radioactive contaminants that are illegal to inject into public water supplies under the SDWA and illegal to sell as ingestibles according to the FD&CA. Unless these contaminants are identified and removed, then no re-saler of such water has intrinsic rights to re-label the product as water with fluoride, while lacking such tests or other listing of contaminants present and in what amounts as dictated by the Food Drug and Cosmetic Act. Intentionally injecting sodium fluoride, a pure synthetic compound, into non-fluoridated water and labeling the bottled water as fluoride water violates the goal of the SDWA. But far more serious is injecting fluosilicic acid complex materials into non-fluoridated water to elevate fluoride to a desired level and then applying the same bottled “fluoride water” label. Fluosilicic acid is a crude hazardous waste according to the EPA and cannot be legally placed into any product designed for human ingestion according to the Food Drug and Cosmetic Act and cannot be given FDA approval without controlled prospective human clinical trials of long duration. Fluosilicic acid contains arsenic, a type/class IA human certain carcinogen, and its injection into drinking water is strictly forbidden by the SDWA. This legal prohibition exists even if the arsenic level in the water is not detectably elevated above the EPA MCL for arsenic. Further, artificial fluorides are known chromosome mutagens when present at levels found in consumer blood in fluoride treated cities, and is a probable cancer promoter and possible carcinogen (NRC, 2006; Connett, ibid). This alone is sufficient to ban either sodium fluoride or fluosilicic acid injections into drinking water, both bottled fluoride water and tap water, even if the artificial fluoride source were entirely free of arsenic and other contaminants mentioned above. If bottled fluoride waters have already received FDA “approval” while containing fluosilicic acid as fluoride source, then such approval should be revoked, in spite of a CFR 21 vaguely worded statement that ‘fluoride [unidentified source] may be added to bottled water to 1 ppm’. Fluoride ion is neither a normal ingredient nor a required ingredient in fresh water—salmon brain is narcotized in otherwise pristine fresh waters at only 0.21 ppm.
The failed gamble must now be addressed, and the FDA is fully equipped to address it, by either 1) instituting a ban on the sale of fluosilicic acid preparations or sodium fluoride offered for intentional human ingestion to treat tissue, and/or 2) declaring requirements, for the manufacturing and distributing establishments of artificial synthetic fluoride compounds sold for human ingestion, to submit animal and human controlled clinical trials data for safety and effectiveness and to request applications for registration and approval of facilities to the FDA for formulating artificial fluoride compounds to be ingested to treat humans. Any use of already-approved-for-use sodium fluoride as an ingestible, rather than a toothpaste ingredient, is not FDA approved, even though FDA states that it regulates bottled fluoride water fluoride. Any use of toxic hazardous waste fluosilicic acid liquor, currently sold for human ingestion in public water supplies, from fertilizer refineries, for use in either toothpaste or bottled water to elicit effects on humans is also not FDA approved.
Fluosilicic acid liquid industrial waste from the fertilizer industry that is sold for anti-caries consumption purposes contains known contaminants of lead, arsenic, and various radionuclides (Environmental Sciences and Engineering Magazine; July 2008). If the FDA is planning to, or already has, allowed fluosilicic acid preparations to be added into either toothpaste or bottled water, let it be known that such use is 100% opposed by this petitioner, and is illegal for FDA to approve because no controlled prospective human clinical trials have ever been done with this injected crude hazardous waste material and such treatments would violate the Food Drug and Cosmetic Act for drugs in water and the Safe Drinking Water Act for contaminants in public water.
The FDA response implies that already-fluoridated water upon arrival at a food processing establishment can contain ingredients not regulated by the FDA. Nevertheless it is a violation of the goal of the SDWA if one were to authorize or provide tacit FDA approval for fluosilicic acid treated water. This material contains substances that are not normal ingredients in any natural water supply in the United States. It is not possible to approve fluoridated water that is not natural, as this would violate the explicit intent of the Federal Water Pollution Control Act section 101a which exists to maintain the natural chemistry of U.S. drinking water supplies (see petition). The mere existence of natural calcium fluoride in bottled or public water supplies DOES NOT carry with it the presumption that natural U.S. waters, such as pristine waters of the Pacific Northwest that are devoid of fluoride, are somehow ‘abnormal’ that require treatment with either natural calcium fluoride or artificial sodium fluoride or artificial fluosilicic acid for its fluoride. Such a claim is not a statement of fact and has no evidence in proof.
Incredibly, as it stands, most in the U.S. general public perceive that the FDA must have given tacit approval for fluosilicic acid diluted with caustic soda for human consumption, which is now the most widely abused ingested unregulated chemical agent in the United States. If a rail-car or truck were to crash and spill fluosilicic acid, many in the general public would prefer not to waste the already-paid-for material and could collect it for use as an oral prophylactic or ingestible, when instead the entire region around such a spill would have to be evacuated to avoid hydrofluoric acid vapor inhalation and gross toxicity, that would have to be neutralized with calcium hydroxide to avoid physical contact that readily dissolves flesh to the bone. FDA inaction in instituting a ban on the manufacture, re-labeling, sale, interstate transport and mass use of these unpurified materials for human ingestion purposes, with lack of compliance to either Food Drug and Cosmetic Act or SDWA provisions for this substance, is in part responsible for public corrupted perception. Any use of fluosilicic acid materials, currently or in the future, sold as an additive for either bottled water, toothpaste, or mouth rinses for anti caries purposes, as is currently practiced and implicitly allowed by the EPA and the FDA for tap water, that are not planned to be banned by the FDA, would constitute complete disregard for oversight responsibility on the part of the FDA.
The US. EPA has no training or personnel to monitor mass medication treatments of human tissues by using public water supplies as the vehicle for drug delivery. EPA has no internal regulations or rules with which to warn consumers of known side effects of fluoride accumulation in bone, or warnings that infant formula must not be mixed with fluoridated tap water (now concluded by the American Dental Association and the CDC), or to warn of or to monitor side effects from either over-dosage or long-term suggested use, or to warn or monitor population groups allergic to fluoride exposure or the infirmed, undernourished and most susceptible citizens necessary to be protected form harm by any drug intervention delivered on a mass scale. Low dose fluoride consumption from water supplies is associated with low grade anemia widely, and in controlled prospective studies (the only known such controlled human trials data to date) 1% of people experience intestinal discomfort drinking 1 ppm fluoride water, and in some detectable brain function alterations and another 1% of people are allergic or hypersensitive to fluoride exposure even at low doses (NRC; www.fluoridealert.org, Connett, ibid). The EPA has no authority, ability, facilities, official orders or permission to monitor these fluoride issues.
The EPA has been advised by the National Research Council in 2006 that the 4 ppm MCL, currently allowed for fluoride by the EPA as a contaminant in U.S. city water supplies, is not protective of human health and informed the EPA it must be lowered immediately. The NRC panel of authors is composed of a balanced board of world experts on fluoride toxicology and pharmacology. After 4 years, the MCL has not been lowered because the EPA has no ability to examine the broad biological effects on populations after long term use of fluorides, as either a contaminant, natural or injected, or in particular when used intentionally as a mass medicament to treat humans. This is the very reason the EPA asked the NRC to examine the pathological effects of water fluoride consumption in the first place. The collection of this body of knowledge has been useful to the EPA, but not actionable. The NRC statement that the current allowed MCL is not protective of human health, that people are sickened in a variety of ways drinking 1-4 ppm fluoride water, DOES NOT mean that the practice of water fluoridation using 1 ppm is “consistent with the NRC Report,” as many proponents of the continuance of fluoride programs claim have claimed about the NRC report (personal communication with Dr. D. Lyman, CA Department of Health and Human Services, Sacramento, CA; see Connett, p 201; personal communication with Dr. Kathleen Thiessen, NRC Report co-author)
Any regulatory role for mass medicament of people in the U.S. belongs to, and is the sole purview, of the U.S. FDA. Many EPA officials recognized in 1985 that fluoride water does not decrease teeth cavities in any population age group studied and that stoppage of water in any city does not lead to increased cavities in consumers (Hileman, Chemical and Engineering News,1985; Connett, ibid). Recently proved beyond doubt, in confirmation of these facts, artificial fluoride from fortified water supplies cannot influence teeth structure or health, since levels of fluoride from water supplies measures in a range, for saliva, blood and water, from only 0.02 to 1 ppm, miniscule compared to the extremely high levels in topical fluoride applications required to elicit effects on teeth tissue. The U.S. CDC and ADA agree that fluorides do not exert teeth tissue effects systemically from the blood stream, but only by topical mechanisms as in toothpastes (Connett, ibid), which are of course regulated by the U.S. FDA as drugs (see Orange Book of Drugs, US FDA attached listing).
The circle of facts is complete, correct, and multiply confirmed. Fluoride in water, as opposed to high levels in topical pastes, does not decrease cavities and indeed chemically cannot; its absence does not decrease cavities; and cities that halt fluoride injections in public water supplies do not exhibit any increases in teeth cavities (Connett, ibid), as fully expected from both the epidemiological studies and the biochemical data. Artificial fluorides, consisting mostly of synthetic crude non-purified fluosilicic acid waste liquor from phosphate fertilizer industrial establishments for use as a mass medicament, must now be fully regulated by the US FDA. The U.S. EPA has not decreased the MCL for fluoride as a contaminant (for accidental un-intended spillage or when present naturally) as the NRC has requested, and is not equipped to regulate, monitor, or evaluate the broad plethora of pathophysiologic adverse health effects in any consumer continuously ingesting, for indefinite long periods of time, artificially manufactured fluoride compounds known with certainty to be calcium chelating, general metabolic poisons, hydrogen bond disruptors and enzyme inhibitors, in many cases at levels lower than those now existing in extracellular fluids of consumers in fluoride-treated cities. The EPA still publicly lists fluoride as a contaminant that at levels near 4 ppm lifetime are associated with bone pain and tenderness and substantial increases in tooth mottling in children, which is the first visible sign of fluoride poisoning. The fact that special allowance is made, unlike for other contaminants enforced not to exceed 1-10% of such an adverse health-effect level, where States are not reprimanded by EPA unless the 4 ppm level is physically exceeded, demonstrates that EPA merely treats the agent as it would an accidental contaminant. Chronic illness and adverse pathology is not monitored or considered in any way by the EPA for any fluoride-injected city, including the well-documented effects in humans of thyroid disruption, IQ alterations, bone cortical defects, anemia and increased hip fractures due to fluoridated bone weakening that occur at fluoride concentration ranges from 1-3 ppm (Connett, ibid, pp 204-205). These data confirm that the level of injected artificial, calcium chelator, diluted fluorides permitted in drinking water must be zero, as required anyway by the Safe Drinking Water Act, which forbids injection of contaminants and drugs into public water supplies. The SDWA regulations were written to protect everyone from contaminants or drugs in water from “known or reasonably anticipated health effects” (Connett, ibid, p. 206).
The health and safety of mass numbers of U.S. citizens, increasingly consuming, and permanently bone-and-brain-accumulating, the fluoride ion from multiple sources, now demands our joint attention. If not for this point, I would feel compelled to apologize for the large length of this response.
Rebuttal Summary: The conclusion to deny this petition is not based on statements of fact, but on false statements, as will be proven, and the denial is thus not acceptable. You will find that the FDA has Nobly never changed its original view in 1963, that artificial fluorides injected into drinking water to attempt to treat tissue is an uncontrolled use of a drug, and that still today the FDA Orange Book of regulated drugs lists artificial fluorides as under the authority of the FDA for regulation of use. Half of fluoride residing in the bloodstream of consumers in fluoride treated cities comes from artificial fluorides in toothpastes, which FDA officially rules is a regulated drug in a regulated drug product. The other half of blood fluoride ion mostly comes from artificial fluoride from the phosphate fertilizer industrial waste product sold to intentionally inject into drinking water to treat human tissue. The FDA response now attempts to deny that artificial fluoride in blood from water is under FDA authority for regulation. This is incorrect, since the fluoride ion is not merely a contaminant that EPA can regulate, but instead it is being administered intentionally to the public as an ingestible after purchase from manufacturers that are not registered with nor approved by the FDA to formulate or sell such ingestibles. The fluoride ion in blood from either toothpaste or fluosilicic acid waste is identical, and the goal of FDA regulations is not to maintain any integrity of toothpaste or any intrinsic property of water as a drug delivery vehicle, but to protect the health and safety of the consumer from fluoride adverse effects and over-dosage.
It is not possible for the U.S. E.P.A. to regulate fluorides when used as drugs, since the EPA regulates accidental water contaminants. The 1979 MOU did not apply to drugs, and the FDA never intended to relinquish in any such agreement any oversight for drugs. The agreement has been invalidated for many years for fluoride, by the rejection by the EPA of any responsibility for fluoride water injectables, now recognized as being not accidental contaminants or water treatment additives, but agents injected for the effects they elicit on human tissue, for which toothpaste fluorides are also formulated and ruled by the FDA to be FDA-regulated. This FDA ruling further invalidates any agreement of EPA oversight for fluorides (made simply because it is public water that is the vehicle used for their dissemination into human tissue). The ruling confirms that indeed artificial fluorides, in particular fluosilicic acid, by reason of use is a drug, not a contaminant, water-sanitizing additive or any other type of non-drug ingredient that might be inferred from the FDA response.
The FDA cannot deny the FDA—artificial fluorides incorporate from topical toothpaste into gum tissue and into blood with normal use, and from ingested fluoride water, whether bottled or tap, into blood upon normal intended use. FDA regulates oral topicals and bottled fluoride water, and the other fluoride drug source, tap water, cannot be ‘un-regulated’ by the FDA. Neither EPA nor its subgroups (such as the NSF) has training or capacity to register establishments that manufacture or distribute fluoride compounds anyway, or to request proof of safety or effectiveness of ingested fluorides, or to evaluate tooth or bone fluorosis or other side effects known to plague consumers in fluoride-injected cities. Fluorides are not FDA approved for ingestion AND fluorides are not legal to disseminate through nontraditional means, whether air, water, or unlabeled packages delivered to consumers without side effects warnings and dosages provided, etc. which is true for any substances, whether an FDA approved drug or not.
Misrepresentation of facts with misleading and false statements to the contrary cannot be used as central focus to deny this petition, so we respectfully request the FDA please consider all content presented herein and to re-evaluate the petition exclusively on the basis of fact. The FDA cannot ignore itself, by regulating fluoride topicals in fluoride water and control regions, regulating fluoride bottled water whether oral topicals are used or not, while at the same time not regulating fluoride drugs administered to fluoridate people via public tap water. These contradictions we hope will be addressed and the petition accepted, as the people of this country who, when informed on the issue, vote against being fluoride-treated.
REBUTTAL:
I. CONTAMINANTS ARE TOXICS. ADDITIVES TREAT WATER. DRUGS TREAT PEOPLE.
A. ‘Contaminants’ in Drinking Water are Materials that are Not Desired.
Some contaminants are natural such as arsenic, and some being accidental such as pesticides. These contaminants in most cases are properly regulated by the EPA. Fluoride compounds are contaminants if present naturally or accidentally in water supplies.
B. ‘Additives’ are Injected into Water on Purpose to Treat Water.
Additives are used with the intent to sanitize water, and include for example chlorine and alum aluminum.
1. Additives are regulated by the non-governmental agency the National Sanitation Foundation (NSF), but without official Congressional authority.
2. Fluoride in no case is an ‘additive’ because the purpose of all water additives is to sanitize water–fluoride is not injected at sufficient levels to inhibit microbial growth or with the intended purpose to sanitize or alter properties of the water—it is added specifically to elevate fluoride ion in tissues of all consumers.
(Fluoride is also neither a normal ingredient nor a required ingredient in fresh drinking water. Natural pristine U.S. drinking waters are devoid of fluoride and must be so to support species of fishes. Salmon are the ‘canary in the cave’, being narcotized and unable to migrate for spawning at fluoride levels of only 0.21 ppm where salmon runs collapse. Some natural materials in water, such as arsenic, and the less toxic natural calcium fluoride in selected waters, are an aberration to be avoided, not a material to be sought. Human breast milk is devoid of fluoride since infants are unusually sensitive to fluoride accumulation into tissues. Natural calcium fluoride also is associated with fluoride accumulation and at sufficiently high levels with significant bone derangements).
C. Drugs are Administered on Purpose to Treat People; Fluorides Artificially Enriched for Ingestion to Treat Tissue are Drugs
1. Fluoride when used with the intent to prevent dental caries is defined twice as a drug by the Food, Drug and Cosmetic Act:
a. “21 U.S.C. 321 CHAPTER II—DEFINITIONS (g)(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;”
Sodium Fluoride is listed in the 2007 US Pharmacopoeia pages 3194-3196. Congress and the President have clearly defined drugs and fluoride is listed.
b. “21 U.S.C. 321 CHAPTER II—DEFINITIONS (g)(1) The term “drug” means . . . (B) articles intended for use in the . . . prevention of disease in man or other animals;”
(WA State Board of Pharmacy, letter to B. Osmunson, DDS, June 4, 2009, RCW 69.41.010(12) defines legend drugs: WAC 2460883-020(2) states legend drugs are listed in 2002 Drug Topics Red Book, see Appendix A, WA Board of Pharmacy, 6 09: artificial fluorides are listed drugs).
2. Both professional and public opinion is that artificial fluorides intentionally injected into public water supplies are drugs, with the intent to prevent disease, dental caries, confirming again the longstanding correct, Noble position of the FDA since 1963 (see enclosed letter), that any artificial fluoride chemical intentionally injected into water for human consumption is an uncontrolled use of a drug. Many substances that are poisonous, some natural, some synthetic, become drugs when administered in manipulated doses. Sodium fluoride, fluosilicic acid fluoride, stannous fluoride, and other synthetic fluoride compounds are such drugs. Calcium fluoride also can be, because fluoride is not a physiologic body component.
3. California AB733 laws and its derivatives state that fluoride is to be injected into public water supplies for the purpose of decreasing dental decay in consumers. This means that CA recognizes fluoride injections as drugs, for the effect the ion has on people–it is not mandated to be a water additive nor is it mandated to be an intentionally injected contaminant subject to regulations by the EPA—the chemical is intentionally injected to elicit effects on human tissue. Similarly written laws exist in many other U.S. states that all are invalid due to non-compliance with regulations of the Food Drug and Cosmetic Act.
4. Drugs are used for the effects the agents have on humans and require by Federal drug law monitoring of side effects, health conditions of the patient and FDA approval based on controlled human clinical trial data for safety and effectiveness.
5. All artificial fluorides including fluosilicic acid are drugs when intentionally injected into water to purposely affect human tissue (see chapter on fluoride injections in Goodman and Gilman’s Pharmacologic Basis of Therapeutics and court transcripts attached). Absence of fluoride does not cause cavities or any adverse human condition, proving that fluoride is not a mineral nutrient or supplement of any kind (see FDA communication in petition and letters enclosed). Fluoride has no caloric value and is not a food, and fluorides are not additives that sanitize water nor are fluoride compounds ’normal water ingredients’. Most fresh drinking water is naturally devoid of fluoride ion, as is normal human breast milk, the most nutritious water-based food an infant can consume. The presence of calcium fluoride can occur in some water naturally but is an aberration, not a normal water ingredient, and is associated with chronic bone and tissue degeneration given sufficient time to accumulate the ion during lifetime consumption.
FDA regulates all drugs and supplements and materials used as such in the U.S.
Although some in the FDA may now consider or argue that FDA has no responsibility to regulate fluoride used as a drug if it happens to be disseminated in public water supplies, rather than the air, or in delivered packages, etc., please examine the FDA public published information, in the Orange Book of FDA regulated drugs, and you will find that artificial fluoride drugs (both in toothpaste and as intravenous injectables) are indeed under the purview of the U.S. FDA (see enclosed copy of an official public FDA page). Further as you know, CFR regulations have been established for fluoride bottled water which is an ingested product.
FDA regulates artificial fluoride drugs in toothpaste (CFR 21 Capter I, Subchapter D, Section 355) and has ruled officially that toothpaste is a drug, and have ruled that artificial injectable fluorides for intravenous use are a regulated drug. It is not possible for FDA now to deny that the FDA lacks authority to regulate artificial fluosilicic acid (or sodium fluoride) manufacturers for fluoride use as medicaments to intentionally treat humans. If this is still unclear to anyone at the FDA, please have them examine the 2006 National Research Council Report on Fluoride in Drinking Water, chapter 2 entitled “Measures of Exposure to Fluoride in the United States”, where it is clearly proven that only half on average of all fluoride in the bloodstream of consumers in a fluoridated city comes from water containing 1 ppm fluoride. The other half comes from fluoride in toothpaste (that contains much higher concentrations) that are difficult to completely avoid swallowing—fluoride is an indestructible material that penetrates gum tissue and is not able to ‘disappear after use’ and instead finds its final resting place in bone. The fluoride F- ion injected into water is identical to the fluoride F- ion formulated in toothpaste and is of course regulated by the FDA in products intended to treat human tissue.
Therefore, the conclusion presented on page 3 of the FDA response is unfortunately false and is also misleading, that “the EPA, not the FDA, has responsibility to regulate the use of artificial fluoride compounds in public drinking water.”
1) As above, artificial intentionally injected fluoride in water is neither an additive nor an accidental contaminant, because it is purposefully, willfully injected to elevate blood fluoride levels in consumers as an anti-caries ingestible. Artificially injected fluorides are recognized by the FDA as drugs when injected into public water supplies, and it is an uncontrolled use of a non-FDA-approved drug with a non-FDA-approved method of dispensation.
2) The EPA does not have regulatory authority over drugs, whether injected into public water supplies or by prescription, regardless of whether the FDA prefers that this were the case or requesting unauthorized agreements to that effect. The EPA does not regulate drug use and does not have Congressional authority to do so. The FDA has internally attempted to delegate responsibility to the EPA for water injected fluorides, but in actuality, apparently unbeknownst to the FDA even now 25 years since EPA denied such authority (see attached EPA letter), EPA still refuses to accept that responsibility that the FDA response now claims. EPA officials wrote to me that EPA officially gives such responsibility to individual States and does not regulate fluoride use in water themselves. One can kick the horse, but a horse that cannot budge (because it has no Congressional authority to regulate drugs, only contaminants that end up in water accidentally or even intentionally by not following controlled injection protocols) cannot be said to have “authority and responsibility” for the matter, as claimed in the FDA response.
Moreover, as stipulated in the attachments, the FDA agreement mentioned (Memo of Understanding MOU) with the EPA was made specifically for water additives or contaminants, when in 1979 some individuals improperly thought of fluosilicic acid and sodium fluoride as additives, when they are not. Nor does the EPA regulate water additives anyway, EPA regulates contaminants; the EPA mission is to safeguard the environment, not drinking water sanitation additives, which EPA in 1985 relinquished, also without Congressional authority, to the private entity, the National Sanitation Foundation (see attachment, and NSF International Standard/ANSI 60, 2009, $300.00 retail fee, describing data for water districts on fluoride as a water treatment chemical). NSF in their 300 page document merely treats fluosilicic acid as though it were a seemingly normal water ingredient, and is listed together with additives injected to sanitize water, but which is given special permission to exceed the EPA Maximum Contaminant Level concentration that all additives are required by NSF to follow! (relevant pages enclosed). Neither does the EPA have any authority to monitor side effects of ingested drugs dispensed through public water supplies. It has no basis upon which to define susceptible individuals in a population to unwanted drug effects, nor any basis upon which to warn the infirmed of potential side effects of long-term consumption of any drug. Nor does EPA evaluate the extent and seriousness of tooth and bone fluorosis now ongoing and accumulating in consumers in fluoride-drugged communities over lifetime drinking or those who are allergic or exceptionally sensitive to artificial fluoride exposure. EPA personnel have no training for such tasks and has no authority to require water districts, or manufacturers of fluoride compounds intended for human ingestion to treat tissue, to register their establishments, or to request data for evaluation of safety or effectiveness of any injected materials intended to treat humans. This is explicitly as you know the sole purview, authority and responsibility, of the U.S. FDA; and the general public is extremely grateful for that choice on the part of our United States Congress.
3) The EPA has already written in detail that EPA does not take responsibility to regulate fluoride injections into public water supplies! (see attached documents); the FDA may contact the EPA at any time and discover that this has been the case for a very long time. EPA deems that intentional fluoride injections are a “States’ rights” issue, as your own response itself intimates. Thus, the FDA has been doubly misinformed; the EPA transferred long ago all responsibility for artificial fluoride injections to the National Sanitation Foundation, a nongovernmental private agency that regulates water additives that sanitize water, knowing full well that intentional injected fluorides are not then considered contaminants under their purview. And, EPA has no intention of ever regulating and monitoring the effects of injected water fluorides, in spite of the desire, by some at the FDA, for the EPA to have authority to regulate injections of these chemicals used as mass medicaments. It cannot be said that the EPA “has authority to regulate” fluorides because this would mean that the EPA accepts that authority. In a relay, a baton can only be said to have been passed, if and only if the receiver holds the baton. If the baton is dropped, the baton was not passed—it was dropped. The EPA dropped authority to regulate controlled fluoridation of public water supplies 25 years ago–that baton, the authority, was not given to the EPA by the FDA in the MOU the FDA response references—it was attempted but does not exist.
If the MOU were legally binding as claimed, then the EPA decision not to monitor fluoride injections (including not only concentration, but total doses, and safety and effectiveness in the healthy and in the infirmed now known to plague those overdosed with fluoride) into U.S. waters would then have been considered an illegal abrogation of duty. The EPA would be fully culpable and responsible for violating the SDWA which forbids injecting either contaminants into water under any circumstances or medicaments of any kind through public water supplies. But of course this is not what has transpired, since the EPA has chosen long ago to not be involved with artificial fluoride intentional injections and has internally decided to force that obligation elsewhere; so the FDA claim in the response to the petition, that EPA “has authority and responsibility to regulate fluoride in water” is not only part incomplete and part misleading, and is an incorrect claim, not a statement of fact. The FDA attempted to “give” the EPA that authority, but the EPA has refused, permanently, to accept it. Enclosed is a document proving that the FDA has no intention of relinquishing authority for drug oversight to the EPA. The MOU in 1979 is now invalid because at that time, the assumption was made that fluoride was a contaminant or other non-drug agent or, if it were a drug, because it is administered through public water supplies, that EPA should regulate it. Since that time, FDA has assumed regulatory authority for artificial fluoride as a drug in toothpastes and bottled water and in mouthwashes that must comply with all applicable FDA regulations (see attached Orange Book data), because regulation of a drug is separate from regulation of how it is disseminated.
The FDA is the legal guardian of protecting consumers from drug over-dosage, and from exposure to non-FDA-approved drugs, not the EPA. The FDA is in charge of regulating artificial fluoride drugs and in the end if FDA does not ban these injections (now known with certainty to have no possible effect on teeth from water or saliva, while having known adverse effects during residence in blood, brain and bone) could risk being held most culpable for the greater part of our ongoing National crisis of tooth and bone fluorosis, that continues to dramatically rise in ALL fluoride treated cities (Pollick, CADHHS; Thiessen, attached; Connett, ibid) due to fluoride overdose from public drinking water intentionally injected with artificial fluoride drugs, including sodium fluoride and fluosilicic acid. This can be immediately repaired when the FDA requests water districts to supply clinical trials data demonstrating safety and effectiveness of fluosilicic acid and sodium fluoride in achieving claims of benefit by ingestion without significant harm to consumers, and by halting sale of these agents until such regulations have been met; or if FDA straight out bans fluorides sold for human ingestion. The FDA stands then to be heroes for this country, because the FDA has all along Nobly denied FDA approval for artificial fluorides for human ingestion.
Bottled water CFR 21 regulations do not state any allowance to inject artificial synthetic fluorides directly into the product. If no FDA action is taken on this petition, then FDA would clearly remain quite vulnerable to such an action. It is obviously clearly time to continue the FDA Noble action, and to now complete the job, by instituting the ban until all conditions required by the Food Drug and Cosmetic Act are achieved by the establishments involved in producing, formulating, and dispensing the synthetic fluoride chemicals currently being used without FDA permission as a medicament in 65% of all U.S. water supplies to treat humans. Fluosilicic acid treated water is now used as chief ingredient for sale as bottled water in some cases. Soon this hazardous waste material could well be purchased from these manufacturers for direct injection into either bottled water or also for use in toothpaste, where swallowing is unavoidable even during normal use and is substantial when flavorings are also added. A single FDA CFR 21 statement that “fluoride may be added to bottled water” to 1 ppm does not specify the source, specific form or chemical formula for the ‘fluoride’ and is thus erroneous. Artificial fluorides are added as anti-caries agents into bottled water, though there is no doubt that water fluoride cannot decrease teeth cavities as evidenced in massive population studies and from biochemical measurements of saliva fluoride at 0.02 ppm as a filtrate of blood during fluoride water consumption. The goal of the SDWA to prohibit adding artificial drugs to public drinking water is essential to follow, to prevent adverse health, which, in the case of fluoride in tap or bottled water, includes fluorosis of children’s teeth and bone weakening effects in all consumers.
Historical timeline of facts: The people of the U.S. rely on the FDA for protection and yet here we are, where no governmental agency desires to accept responsibility for regulating the safety or effectiveness of fluoride compounds used to treat humans by ingestion. Water fluoride consumption in cities treated with sodium fluoride or fluosilicic acid, rather than natural calcium fluoride which is assimilated poorly, on average approximately doubles the amount of fluoride ion incorporated into consumer blood, on top of that which enters from FDA regulated toothpaste fluoride (NRC, ibid). Ignoring the substantial blood contribution from artificial fluorides in water undermines and renders ineffective the careful regulations intended to be applied to fluoride drugs currently by the FDA.
Remember, the salient true history is this:
1) artificial sodium fluoride unlawful experimentation began among people treated in Grand Rapids, MI water supplies in 1945 for presumed anti caries effects. The medicament was not subject to FDA review, because this time period was prior to FDA guidelines that require submission of clinical trials data to solicit FDA approval.
2) In 1963 the FDA ruled that injecting artificial fluorides is dissemination of an “unapproved drug through the public water supply in an uncontrolled manner where dosage cannot ever be regulated” (and is not avoidable by the sensitive population, while bottled water today can be refused).
3) A 1979 MOU attempted to assign to the EPA, from the FDA, regulation authority for water injected fluorides, presuming mistakenly that artificial fluorides could be thought of as either contaminants or water additives, or a natural ingredient in water (though all natural water fluorides dissolve from natural, relatively insoluble, lowly assimilated, nontoxic calcium fluoride, LD50 = 5,000 ppm, vs. artificial fluoride LD50 = 125 ppm), as though being used as something other than a human treatment/medicament.
4) The EPA in 1985 realizes that fluorides are used to treat human tissue, the definition of a drug, and are not additives that sanitize water or water ingredients since they are added to affect teeth, found the National Institute of Dental Research massive study indicating tooth decay is unrelated to water fluoridation, recommended suspending endorsement of fluoridation (Chemical & Engineering News, May 8, 1989, vol 67), then found evidence of pathologic harm (Connett, ibid), and today refuses to accept responsibility to regulate the injections, having instead only authority over accidental contaminants, not drugs disseminated through water supplies.
5) FDA currently regulates artificial sodium fluoride as a drug in toothpaste, which is also labeled an FDA regulated drug. Toothpaste fluoride we now know is responsible accidentally for half of the fluoride ion content of human blood of consumers in a fluoride treated city, while water-injected sodium fluoride or fluosilicic acid fluoride constitutes the other half (NRC, 2006). Saliva fluoride from drinking water is virtually undetectable (NRC, 2006), unable to exert any anti-caries effect compared with toothpaste fluoride at 1,500 ppm that can have use for such purposes. These are the facts, all while blood-borne fluorides, which are not mineral nutrients according to FDA ruling, accumulate permanently in a pathologic manner into bone (NRC, 2006, p.94, see petition) from all artificial fluoride sources, chiefly being water-borne from intentional ingestion, and from toothpaste that deposits onto gums that cannot be spit out.
Fluoride compounds are drugs according to the FDA (as shown throughout this response), still have no FDA approval for intentional ingestion from either toothpaste or from fluoride-mass-medicated public water supplies (see original petition), and FDA has still yet to obtain, from fluosilicic acid or other fluoride manufacturing establishments and distributors, formal registration and application for a permit required by the FD&C Act, or controlled human clinical trials data for long term safety and effectiveness soliciting FDA approval for ingestion of fluoride compounds. Because of these historical facts, which are immutable, that cannot be changed by memoranda, new laws, amendments of old laws, etc., it is now time for the U.S. FDA to complete its role and:
a) ban the sale, packaging, labeling, transport and distribution of artificial fluoride compounds that are intended to be used as a water-based ingestible material, usually sold for injection into U.S. pubic water supplies with the intent to mass medicate the U.S. population to achieve effects on human tissue. This option is requested since ingested fluoride levels in blood and saliva do not and cannot benefit teeth structure, and there is no level low enough to affect teeth without abnormal incorporation permanently into bone; and/or
b) make a nationwide declaration that all manufacturers of artificial fluoride compounds, mainly fluosilicic acid H2SiF6 but also sodium fluoride NaF sold for human ingestion, must halt such sale and use until proper controlled human clinical trials data for safety and effectiveness of said fluoride compounds are conducted by competent professionals under appropriate conditions (using calcium-rich and calcium-poor water as drug delivery vehicles, etc.) to obtain FDA approval for proposed use as a new drug. All regulations of the Food Drug and Cosmetic Act as listed for new drug applications in the Code of Federal Regulations must be met prior to any marketing, labeling, packaging, transport, or use of such fluoride compounds for human consumption by ingestion, whether sold to bottled water establishments, or for distribution through tap water supplies, or via any other medium intended for human ingestion (the minimal required second option).
Fluoride injections prohibited by SDWA, whether drugs or contaminants:
On page 2 paragraph 2 the FDA response states that fluosilicic acid injections into water falls under the Safe Drinking Water Act of 1974. Indeed, fluosilicic acid can be a pollutant (when accidentally spilled into water), and is classified a toxic hazardous waste by the EPA, that is illegal to inject into any public waters under the SDWA. Please understand as well that the SDWA also prohibits the injection into drinking waters of the U.S. any substance to treat human tissue. The SDWA specifically states at 42 USC 300g-1(b)(11):
No national primary drinking water regulation may require the addition of any substance for preventive health care purposes unrelated to [removing] contamination of drinking water.
For greater clarification, the EPA was contacted and responded:
“The Safe Drinking Water Act prohibits the deliberate addition of any substance to drinking water for health-related purposes other than disinfection of water (www.doh.wa.gov/hsqa/professions/Pharmacy/documents/July 2008.pdf
In spite of laws against the practice, the EPA does not regulate controlled injections of fluosilicic acid or sodium fluoride, as previously mentioned, because these injections, being mistakenly thought to have anti-caries benefit, are not considered currently by the EPA as regulated, even though the injections are prohibited by the SDWA. EPA gives full liability for artificial fluoride injections below 4 ppm to the states and water districts (see attached letters). So the claim in the FDA response that the EPA regulates injected fluorides proves either that: 1) the FDA has not been informed of the EPA decision to dismiss responsibility for fluorides in water below 4 ppm, or 2) that the FDA accepts the use of a hazardous waste for intentional human ingestion that is now ongoing in over 65% of all U.S. water districts in violation of the Safe Drinking Water Act. Both of these charges are not in keeping with the original mission of the U.S. FDA, to protect U.S. citizens from unapproved drugs.
The NSF private agency mentioned has intentionally allowed and, without authority from the Congress, have attempted to ‘certify’ fluoride water injections that bypasses their own Standard 60 regulations prohibiting any additive to be present at more than 10% of the EPA allowed Maximum Contaminant Level (MCL), under the pretense that it is not a contaminant or additive, but rather an ingredient in ‘normal’ water. Depending on the particular water district, fluorides are now injected at 25-100% of the MCL for fluoride that is listed officially by the EPA as a contaminant. U.S. water districts presume this to be ‘certified’ and in many cases this certification is actually believed to constitute FDA approval (personal communication with water district anonymous personnel).
If there is any doubt regarding the unethical nature of NSF Standard 60, read through it looking for any reference to the 2006 NRC Report. There is none. Also (see attached copies) the only significant listing for fluoride in the entire massive document is as a ‘miscellaneous ingredient’ and that the values allowed as a contaminant is 0.2 ppm but as an added substance is 1.2 pp. NSF standards are outdated and have no health or dosage consumer information on any fluoride compound, and every water district which fluoridates is relying on a sham certification .
Tudor Davies, former director of the Office of Science and Technology for the EPA stated in his April 2, 1998, letter to George Glasser the following:
“In the United States, there are no Federal safety standards which are applicable to drinking water additives, including those intended for use in fluoridating water. In the past the EPA assisted the States and public water systems through the issuance of advisory opinions on acceptability of many additive chemicals. However, the Federal advisory program was terminated on October 4, 1988, and EPA assisted in establishment of voluntary product standards at NSF International. “
Resolving Contradictory FDA Views:
The FDA has unfortunately presented self-contradictory statements—on the one hand FDA claims the EPA is regulating (and thus allowing) injections of fluoride contaminants as though they are not drugs into public drinking water—but on the other hand the FDA has historically officially labeled intentionally injected fluorides as drugs, which because of reason of use is a proper label (fluoride is intentionally added specifically for the effects it has on human tissue). The EPA does not have rights to regulate intentionally-injected contaminants because this is a Federal crime and requires no EPA ‘regulation.’ EPA also does not monitor drug overdose or side effects—that is the purview of the FDA and which requires controlled clinical trials data submitted to FDA for both safety and effectiveness in the actions of the compound proposed for human consumption.
The FDA CDER has jurisdiction, authority and mandate by Congress under 21 U.S.C. 321 CHAPTER II—DEFINITIONS (g)(1) both (a) and (b) to regulate the unapproved misbranded and adulterated unlabeled fluoridated water drug.
The effectiveness and safety of fluoridation are not scientifically or legally reviewed by manufacturers, in part because of lack of FDA CDER oversight and drug regulatory enforcement action. The public is placed in harm by lack of FDA CDER drug regulatory oversight.
As a medical research scientist of over 35 years, with expertise in chemical toxicology and blood clinical chemistry and broad knowledge of toxic artificial fluoride calcium-chelators listed on all poisons registries, and which have been intentionally used to drug human tissue via ingestion into blood in some U.S. drinking water since WWII, I attest that none of these clinical trials data have been submitted to the FDA, because they do not exist (see letter from New Jersey official). Neither do we even have reliable acute or chronic testing in humans for toxicity of natural calcium fluoride.
Statements have been submitted praising the dental benefits of fluoride water (see attachments), none being controlled clinical trials data that are instead endorsements and anecdotal observations among people in fluoride treated towns living there for undetermined time periods with varying diets, incomes, and hygiene habits, etc. that do not fulfill regulations listed in CFR 21 for clinical trials data required to solicit FDA approval.
In fact, the most careful taxpayer funded study ever completed by the National Institute for Dental Research funded by taxpayers proves the statements to be false, where decreases in cavities were not found that may be ascribed to fluoride in drinking water. The Newburgh New York data also proved that after 10 years, residents using fluoride water had no decrease in teeth decay–the original notion that there was a decrease was based on the fact that teeth eruption was delayed in residents of the fluoridated city while such missing teeth were counted as absence of cavities. Again, a hammer is a safer anti caries agent since it doesn’t accumulate long-term in blood, bone and brain.
The FDA current response choice not to ban fluoride drugs from water, AND to confer such regulation to the EPA, is thus incorrect and improper and arrived at by accepting false statements as though they were true. This error left uncorrected would result in the continuance of fluoridated water consumption in U.S. cities without ANY Federal agency responsible for oversight. Only the FDA has that authority, and the FDA decision to refuse that authority is not legally binding nor authorized by the U.S. Congress. The FDA does this on its own accord. The FDA is responsible for any adverse health effects in consumers as a result of allowing this artificial chemical to be widely used throughout U.S. water supplies as a drug to treat people, even though no controlled clinical trials with fluosilicic acid have been submitted to the FDA for proof of either safety OR effectiveness.
Indeed FDA regulates synthetic fluoride drugs ALREADY, as listed on public FDA documents (FDA CFR 21 regulations listing artificial sodium fluoride as a regulated drug in toothpaste and mouthwash and other drug products). Sodium fluoride is a synthetic unnatural formulated drug (only calcium fluoride, not a listed acute toxic, is natural) and all water districts in the U.S. first widely used sodium fluoride to mass medicate for oral tissue effects (Connett, ibid). Although synthetic unnatural fluosilicic acid is now used for most water injections, many public water supplies still use sodium fluoride to this date, which is by FDA’s own admission a drug that is indeed regulated by the FDA. Another product, a fluoride intravenous injectable, has been discontinued, and it is also perfectly acceptable, legal and indeed necessary to now also withdraw any allowances for use of fluoride drugs as ingestibles, since no data have been provided for safety or effectiveness for intentional swallowing of unnatural synthetic fluorides, and no registration papers required by 21 CFR have been filed with the FDA by either manufacturers, distributors, or processing establishments for synthetic fluorides proposed to be used for human ingestion in either bottled water or public water supplies, or other means of dissemination for the purpose of attempting to treat dental tissue.
EPA relinquishes liability to States and water districts
The EPA wrote to me on this issue and concluded that EPA does not regulate any state fluoride injection program because it is officially labeled a “States’ rights” issue. Any U.S. State that decides to inject fluosilicic acid drugs into water supplies is not viewed as violating regulations from the EPA, as is claimed in your FDA response on page 3. The CA Department of Health and Human Services wrote to me that they only perform fluoride treatments as described by the Centers for Disease Control in Atlanta, GA, and do not accept liability or authority to intervene when any tap water supply is treated with fluoride drug compounds. CA through its Dept. of Health Services accepts no responsibility or liability for forcing, enforcing or regulating water fluoridation programs—it was stated to me to be the jurisdiction and responsibility of the Oral Health Division office inside the CDC. However, the Oral Health Division wrote to me that their agency has no responsibility or authority for water fluoridation either, and only recommend its use and does not force states or municipalities to do so, proving that regulation is not the purview of the CDC. Indeed, the CDC officially writes to water districts in support of the practice that “fluoride injections are safe and natural”, and yet wrote to me, upon questioning how long-term such an endorsement is expected to hold, that CDC does not accept any liability for a water district decision to fluoridate–all liability lies with cities, and the CDC does not claim fluoride injections are safe for the lifetime of a consumer. This doublespeak is a contradiction which plays on English wording that fools gullible water districts and city officials into beginning the practice, without realizing there is no proof it will remain safe over continuous long-term, or lifetime, consumption.
The subject of the EPA deciding on its own accord that a State, as intimated in the FDA response, has rights to enforce mandatory fluoridation of a public water supply is itself reasonable to discuss. If it were a States’ right, then the EPA is absolved from monitoring for adverse health effects and for effectiveness in decreasing cavities during long-term consumption of fluorides injected into public waters. This arrangement was made years ago because EPA has no training to accept controlled clinical trails data testing safety and effectiveness of any drug, and the arrangement as one would expect is now recognized to be false. Studies requested, by the EPA, of the NRC proved that 4 ppm is “not protective of human health.” So the notion that a state has rights to enforce fluoridation as a mass medicament without FDA approval is false and not legally binding. The EPA is obligated to adhere to the Safe Drinking Water Act to protect citizens from contaminants, and attempts to do so with the MCL’s designed to minimize gross poisonings. But EPA cannot endorse a state to conduct mandatory fluoridation, which is not an accidental contaminant but a medicament, because no controlled clinical trials data have been provided to the EPA demonstrating either safety or effectiveness after long-term consumption. Notice that intentional injections of fluorides at 1 ppm are not considered a violation of law by EPA, even though the NRC concluded that fluoride promotes cancer and other detectable adverse effects at levels used in water supplies, for which any such injection is prohibited by the SDWA. Such a glaring oversight is clearly shown in the EPA statement that the SMCL of 2 ppm, according to an EPA publication, is set merely to split the difference between levels thought to cause tooth mottling and discoloration vs. a lower level that would be hoped to minimize this adverse tooth effect in exchange for a hoped-for possible benefit. This set level has nothing to with protecting the biological health of the consumer, because the EPA is not equipped to make such a determination for any drug—the agency is designed to regulate contaminants from causing immediate dangerous harm, not to evaluate benefits and side effects of drugs. And any state that decides to fluoridate its citizens does not carry with it rights to avoid FDA regulations for fluoride drugs and their manufacturers.
EPA unable to assess proper contaminant level values for synthetic inorganic fluorides to be protective of human health
EPA public documents available online state: The Safe Drinking Water Act requires EPA to determine the level of contaminants in drinking water at which no adverse health effects are “likely to occur.” The MCLG for fluoride is 4 ppm. EPA has set this level of protection “based on the best available science to prevent potential health problems” [notice that EPA does not state that controlled human clinical trials have ever been submitted to EPA for review]. EPA has also set a secondary standard (SMCL) for fluoride at 2 ppm. Secondary standards are non-enforceable guidelines regulating contaminants that may cause cosmetic effects (such as skin or tooth discoloration). Tooth discoloration and/or pitting is caused by excess fluoride exposures during the formative period prior to eruption of the teeth in children. The level of the SMCL was set based upon a balancing of the beneficial effects of protection from tooth decay and the undesirable effects of excessive exposures leading to discoloration, while bodily adverse pathology is completely ignored from consideration in this SMCL value.
Again, this SMCL is not set to protect human health—it was set to avoid obvious visible deterioration of teeth from fluorosis, the first sign of bodily fluoride poisoning. All fluoridated cities without exception exhibit significant increased levels of tooth fluorosis, so the SMCL is also not protective anyway. Tooth fluorosis is due to overdose of fluoride. The EPA statement that 4 ppm is “protective of human health” contradicts the National Research Council statement that 4 is “not protective of human health” as well as the EPA admission that even 2 ppm is not a margin of safety to avoid fluorosis, just to minimize it. Because proper Food Drug and Cosmetic Act regulations are not being enforced, as required by law by the FDA, this un-moderated, intolerable situation with bone accumulation lifetime, weakening bone, being unnoticed by EPA personnel at the EPA, remains.
Terms used to define artificial fluoride compounds depend on which agency with which one is speaking, and on the intended use of the materials. The FDA response claims that the EPA follows regulations in the SDWA and other Federal laws. My petition also brought up the SDWA to make the point that if fluorides are contaminants, as they can be, depending on dose and circumstance, then SDWA renders the intentional injections flatly illegal and criminal—I placed this statement into the petition because the FDA required I provide any Federal law I know might be considered violated as it relates to the petition at hand. I am glad to hear that the FDA would agree with that assessment when it defines fluorides at times when used as substances other than drugs. Fluorides in water of course are not injected for the purpose of poisoning anyone or any microbial, but to attempt to alter human tissue. With this in mind, the agent is being used as a drug. This use is illegal, lacking clinical trials and FDA approval as a drug, and is illegal by statutes of the SDWA prohibiting injecting drugs into public water supplies. Intentionally injected fluorides are not insecticides, fungicides, or rodenticides (even though fluorides can be commonly used for such purposes), so mentioning the Toxic Substances Control Act and the Federal Insecticide, Fungicide and Rodenticide Act seems to have little significance to the petition.
EPA-FDA Memorandum of Understanding does not apply to synthetic fluorides used as anti-caries ingestibles
A. The MOU 225-79-2001 is an agreement to resolve conflicting legal authorities granted to the EPA and FDA. This MOU only seeks to resolve FDA authority over food in (FFDCA 201(f) (21 U.S.C. 321(f))), FFDCA 402 (21 U.S.C. 341)), FFDCA 406 (21 U.S.C. 346)), FFDCA 409 (21 U.S.C. 348)), and FFDCA 410 (21 U.S.C. 349)).
However, the FDA has separate authority over drugs. FFDCA 201(g)(1) (21 U.S.C. 321(g)(1) and FFDCA 501 et seq. (21 U.S.C. 351 et seq.) The term “drug” is defined in 21 U.S.C. 321(g)
“(1) articles recognized in the official United States pharmacopoeia, official homeopathic pharmacopoeia of the United States, or official national formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or other animals;”
B. The FDA CDER denial specifically references the MOU number 225-79-2001 statement,
“all substances in water used in food are added substances subject to the provisions of the Act, but no substances added to a public drinking water system before the water enters a food processing establishment will be considered a food additive.”
1. The above MOU statement is clearly referencing food processing establishments and not drug manufacturing establishments. For example, should a soup company use water which has had chlorine added before the water enters the soup processing establishment, the label on the soup container does not need to list the chlorine ingredient.
2. The FDA CDER denial is correct that the MOU is in regards to “additives.” Neither the FFDCA nor the SDWA define a drug as an additive when added to water. However, adding substances to public water with the intent to prevent disease is defined as a drug. An additive is intended to treat water. A drug is intended to treat people. The fluoridated water drug is intended for people, not for water and is defined as a drug and not an additive.
3. The FFDCA does not authorize the FDA CDER to delegate drug regulatory authority. The EPA could not enter into an MOU with the FDA which requires the EPA to violate the SDWA. The MOU section is with regards to food, not drugs.
At this point it would behoove the FDA to read the legal amicus brief provided by Attorney James Robert Deal, Seattle, WA in ongoing litigation (“Fluoride Class Action Amicus Letter in Support of Rulemaking Appeal by Washington Action for Safe Water”, Click on http://fluoride-class-action.com/bd-of-health/amicus-letter to read this letter online; Click on http://fluoride-class-action.com/bd-of-health/amicus-letter/amicus-letter-doc to download letter) and legal documents used in litigation now ongoing in Los Angeles (attached), and the text by Bryson (“The Fluoride Deception”, Seven Stories Press, N.Y., 2004), the newly published text by Connett, et. al., “The Case Against Fluoride”, ibid), and current litigation available online by Attorney James Robert Deal vs. the Washington State Board of Health–all proving that the 1979 MOU mentioned was for water ‘additives’ and that artificial fluorides are not additives, but drugs intended to alter human tissue. No Federal agency currently accepts responsibility for oversight of these unethical injections that were first approved without clinical trials by the Public Health Service in 1950 without informed consent of the drugged consumer (Connett, ibid, see attachments).
The amicus letter also contains statements from the CDC and EPA under the Freedom of Information Act that:
1) Although the CDC promotes fluoridation, it admits that “…it is not CDC’s responsibility to determine what levels of fluoride in water are safe….”
2) And that “the EPA has stated it has no intention to regulate fluoride levels or approve additives for tap water.”
3) “Fluosilicic acid is approved by a trade association called the National Sanitation Foundation. NSF is controlled in part by the chemical industries which use and produce fluoride. We believe NSF certification to be invalid and in fact fraudulent.” (see attached Solvay letter).
4) Currently no federal or state agency tests or approves the silicofluoride which is currently used by 92% of the water districts in the country which practice water fluoridation.
We don’t blame FDA for wishing not to regulate artificial fluoride ingested mass medicaments, but we must take charge now, particularly because the practice of medicating people, through non-traditional means without written prescription and informed consent of consumers, is now spreading widely under the guise it has tacit approval by the FDA that has not prohibited it.
May we please send a copy of your response to the EPA and the NRC (the response was stated ‘intended only for the use of the party to whom it is addressed and may contain privileged information’)? The EPA needs to be told in detail this response, that the FDA has assigned all oversight to the EPA for fluoride compounds intentionally injected into U.S. water supplies, in its use as a drug to treat human tissue, without human controlled clinical trials for ingestion purposes ever being provided to the FDA. Many scientists at the EPA have requested for many years that these injections be banned (Connett, ibid) but the request has been unsuccessful largely because EPA only has official authority to regulate ‘contaminants’, not ‘drugs’ (this is, in spite of any MOU, is FDA responsibility).
The United States Environmental Protection Agency Scientists are Opposed to Fluoridation and have written:
“In summary, we hold that fluoridation is an unreasonable risk. That is, the toxicity of fluoride is so great and the purported benefits associated with it are so small – if there are any at all – that requiring every man, woman and child in America to ingest it borders on criminal behavior on the part of governments.”
EPA scientists (NFFE) to the Court regarding the scientific basis for the authorized Recommended Maximum Contaminant Level (RMCL) for fluoride in drinking water wrote:
“. . . NFFE believes that serious errors were made by the Agency in setting the fluoride RMCL . . . the Agency deliberately chose not to base its decision on relevant expertise. . . . The process by which EPA arrived at the RMCL for fluoride is scientifically irrational and displays an unprofessional review of relevant scientific data.”
The EPA scientists have taken the moral high ground in attempting to protect the public in spite of lack of action on the part of the EPA as a whole (Thiessen attached). It is time for the FDA to no longer defer regulatory action.
Colgate Palmolive in public website information (attached) claims that teeth fluorosis damage (a permanent abnormal disfigurement for the lifetime of consumers who are told that fluoride is ‘safe and natural’) is merely an [un-important] “cosmetic” effect, without submitting formal proof of this claim. This claim is contrary to conclusions reached and reported by the expert panel assembled by the National Research Council in 2006. Further, fluorotic subjects often feel it is their poor dental care that caused the disfigurement and often are embarrassed to smile during dating and have more limited employment opportunities.
Colgate states that tooth fluorosis is caused by children swallowing toothpaste while also living in a fluoridated city, and this petitioner agrees with this statement. The admission is remarkable, in that it proves fluoride in blood, which causes teeth enamel degradation during childhood enamel development, comes from both toothpaste fluoride and water-based fluoride ion acting in concert. This is consistent with published data in the NRC Report that half of blood fluoride comes from tooth[paste and half from drinking water (whether bottled fluoride water or tap water), and that this currently is responsible for the massive numbers of U.S. children that develop enamel fluorosis, the first sign of fluoride poisoning that is accompanied with bone and brain fluoride incorporation. The shameful result of the Colgate admission however is the between-the-lines idea that it is somehow the fault of the consumer, rather than the fault of the manufacturers who broadly promote use of fluoride products, for this gross degradation, discoloration and disfigurement of teeth enamel. This petitioner objects to such a claim of fault, because no parent or any consumer could imagine that a mere 1 ppm fluoride that is water-based could possibly contribute to the destruction of teeth during development, when all other fluoride anti-caries products regulated by the FDA contain far higher fluoride concentrations (1,500 ppm in toothpastes, 10,000 ppm in gels, and hundreds of ppm in mouth rinses and washes).
The fact that FDA does not approve swallowing fluoride-enriched materials does not clarify for the consumer that the tiny fluoride ion penetrates into gum and blood during suggested use. The fact that CFR 221 Section 355 regulations suggest fluoride in topical products should not be used in areas with fluoridated water is insufficient warning to prevent enamel destruction when bottled fluoride water is allowed to be sold without warning of tooth fluorosis when used together with fluoride toothpaste, as indicated above. Toothpaste use once or twice a day deposits massive amounts of fluoride onto teeth and gums compared to that from water, and thus blood and saliva. Although CFR 21 regulations explain topical fluoride products must be spit out, such normal use produces substantial levels of fluoride ion in blood. Coupled with fluoridated drinking water, either bottled or tap, causes chronic fluoride poisoning in children with its permanent tooth mottling. The irony is that there is no possible teeth benefit of any kind for fluoride in drinking water which only produces 0.02 ppm fluoride in saliva, while it deposits the entire other half of all the fluoride present in the blood of consumers drinking fluoride water (whether bottled or tap). It is the fundamental imperative job of the U.S. FDA to ban the use of any ineffective and potentially harmful anti-caries fluoride product. After many years of debate, the FDA has not reversed its stance that fluoride additions into public water should be discouraged (see attachments) and would be uncontrolled use of a drug.
One ruling listed in CFR 21 that FDA allows adding “fluoride” into bottled water at levels below 1 ppm violates the goal of the Safe Drinking Water, and the ruling has no actionable use. There is no such entity as ‘fluoride’—there are fluoride compounds, such as natural nontoxic calcium fluoride, and some un-natural fluorides such as sodium fluoride and fluosilicic acid fluoride, which are toxics, but it is not possible to simply add ‘fluoride’. Those who are allergic to and sensitive to low level fluorides, especially autistic children and those with poor nutrition and with kidney ailments, and also heavy water drinkers can readily refuse to purchase bottled water. However, the insidious accumulation of fluoride ion into the U.S. population comes, without consumer permission, from the indiscriminant mass use of fluosilicic acid or sodium fluoride as anti-caries agents produced by establishments without FDA approval. It is virtually impossible to thoroughly eliminate water-based fluorides from ingestion, from either drinking water or foods prepared from same, and it is necessary to ban the sale of these materials for water-based use and indeed for any method of dissemination that is not FDA approved.
FDA ban and other requirements:
The FDA is thus far not in compliance with either the SDWA for fluoride materials injected into public waters or the FD&C Act for dissemination of non FDA-approved drugs by non-traditional means, i.e. through public tap water or other non FDA-approved method. Inorganic fluorides and associated contaminants found in fluosilicic acid preparations, including carcinogenic arsenic and various radioactive materials, are all strictly prohibited from intentional injection into public waters (Connett, ibid see attachments) by the SDWA, and from oral ingestion by the FD&C Act, being not FDA approved for this purpose. Further, thus far there is no intended plan by the FDA to ban their manufacture, sale and use for now. In the absence of a ban on their sale and use as anti-caries ingestibles, the next choices must be made. If synthetic fluosilicic acid is correctly labeled a non-FDA-approved drug, then fluosilicic acid manufacturers and water districts in the U.S. purchasing this material must be contacted by the FDA to explain that controlled clinical trials data for safety AND effectiveness have not been submitted to FDA for fluosilicic acid ingestion, and that the drug is not FDA approved for sale as an ingestible without such submitted data.
Most U.S. water districts, particularly here in Southern CA are unaware of these facts. We citizens are asking FDA to do this because FDA has that authority, where it is a violation of Federal drug law to treat any citizen with any drug without informed consent or with a drug that is not FDA approved. This action is the full authority of the FDA under the Food Drug and Cosmetic Act that requires regulation and permitting of any facility that formulates or produces, packages, labels, transports or sells any agent intended for human ingestion to treat tissue, such as fluoride products intended for human ingestion. Manufacturers such as the Solvay LLC company that sells fluosilicic acid waste materials from Florida fertilizer industry scrubbers such as Cargill, and also now foreign sources from China (personal communication with local water district chemists; Connett, ibid) and others, who sell these agents for use as drugs in the U.S. for human ingestion to alter human tissue, must apply for permits from the FDA.
In the words of the FDA (also see attachments):
Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Specifics are listed in FDA public guidelines, for example 21 CFR Chapter 1, Subpart C, Procedure for Domestic Drug Establishments, 207.20 stating:
"Operators of all drug establishments that engage in the manufacture (such as Solvay), preparation, propagation, compounding or processing (U.S. water districts that formulate fluosilicic acid with caustic soda to inject into public drinking water for ingestion to alter human tissue) of any drug shall register and submit [to the FDA] a list of every drug in commercial distribution.”
Furthermore, the Commissioner has confirmed new and more accurate requirements that apply to drugs to be marketed in the U.S. as approved by the FDA, for which no fluosilicic acid or sodium fluoride manufacturers now marketing materials for use as anti-caries ingestibles has yet to follow. CFR 21, Chapter 1, Subchapter C, Part 201, Subpart F, Section 201.200 states:
The Commissioner of Food and Drugs concludes that:
(1) The failure to disclose in the labeling of a drug and in other promotional material the conclusions of the Academy experts that a claim is “ineffective,” “possibly effective,” “probably effective,” or “ineffective as a fixed combination,” while labeling and promotional material bearing any such claim are being used, is a failure to disclose facts that are material in light of the representations made and causes the drug to be misbranded.
(2) No person may manufacture, sell, transport or give away any new drug without a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the new drug and without labeling the chemical ingredient.
Fluosilicic acid is not ‘fluoride’ and it is illegal to misbrand toxic hazardous waste as ‘fluoride’ and to market the material as an oral ingestible by any manufacturer. The FDA is in charge of regulating any such manufacturer and material, and the sale of any chemical designed for human ingestion, whether or not the material is injected into public water supplies or rather sold to any other establishment or person as an anti-caries ingestible.
Moreover, controlled clinical trials data must be furnished to the FDA for drug approval and is required for fluosilicic acid and for sodium fluoride when used as anti caries ingestibles, as used in either bottled water or tap water, or in any other method of dissemination. CFR 21 regulations for new drug applications indicate that endorsements and claims of longstanding observations of safety or effectiveness are not sufficient to grant FDA approval, which applies independent of how long such claims have been made or what authority makes such claims:
Uncontrolled studies or partially controlled studies are not acceptable as the sole basis for the approval of claims of effectiveness. Such studies carefully conducted and documented, may provide corroborative support of well-controlled studies regarding efficacy and may yield valuable data regarding safety of the test drug. Such studies will be considered on their merits in the light of the principles listed here, with the exception of the requirement for the comparison of the treated subjects with controls. Isolated case reports, random experience, and reports lacking the details which permit scientific evaluation will not be considered.
Any product not in compliance with an applicable drug efficacy notice is in violation of section 505 (new drugs) and/or section 502 (misbranding) of the act.
(b)(1) An identical, related, or similar drug includes other brands, potencies, dosage forms, salts, and esters of the same drug moiety as well as of any drug moiety related in chemical structure or known pharmacological properties.
According to CFR title 21, Chapter 1, Subchapter D, Drugs for Human Use, Part 310, fluosilicic acid H2SiF6 is not sodium fluoride or other fluoride and thus requires application as a new drug. Merely sharing the fluoride ion that is approved for use in dental products as a topical treatment does not show evidence that fluosilicic acid as an ingestible is either safe or effective:
Where experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs would conclude that the findings and conclusions, stated in a drug efficacy notice or notice of opportunity for hearing, that a drug product is a “new drug” or that there is a lack of evidence to show that a drug product is safe or effective are applicable to an identical, related, or similar drug product, such product is affected by the notice. A combination drug product containing a drug that is identical, related, or similar to a drug named in a notice may also be subject to the findings and conclusions in a notice that a drug product is a “new drug” or that there is a lack of evidence to show that a drug product is safe or effective.
As additional proof, please see the appendix for selected Statutes, derived from the FDA Code of Federal Regulations, that are currently violated when U.S. citizens are orally fluoridated with either fluosilicic acid or sodium fluoride, whether disseminated through retail bottled water regulated by the FDA, through public tap water, or other means of dispensation, and whether the fluoride ingestibles are considered experimental drugs, or legend or other drugs. The list of violations is egregious and includes simple requirements for proper labeling of all ingredients, packaging in tamper-proof containers to avoid adulteration en route to distributors, and other regulations required by the FD&C Act that are currently violated by establishments involved in fluoridating the bloodstream of 200,000,000 U.S. citizens intentionally lifetime in perpetuity, regardless of need or lack thereof. Again, no synthetic fluoride compound has ever been granted FDA approval for intentional ingestion because double blind controlled clinical trials simply do not exist.
Alternately, if the FDA attempts to deem that artificial fluoride chemicals sold as water-based anti caries ingestibles are not FDA regulated drugs, but instead are ‘contaminants’ or ‘other substances’ as listed in the FDA response (even though intentionally injected into water to affect people), then we ask the FDA to please contact appropriate authorities for us, with evidence of a crime, the intentional injection of chemicals into public drinking water being a violation of the Safe Drinking Water Act. In either case, we ask the FDA to allow us to submit to the EPA, the general public and to relevant district attorneys and water districts the FDA response letter, explaining the FDA decision, and that thus no Federal agency is now monitoring or assessing in any way side effects of long-term consumption of injected fluosilicic acid fluoride, for either fluorosis mottling of teeth, bone incorporation, or any other toxic effects recognized by fluoride toxicologists as threats to humans now in U.S. fluoridated cities after long-term consumption.
For the FDA to continue to not regulate, or advise on matters of, anti-caries fluorides injected into tap water that are not FDA-approved, constitutes a reversal of official FDA policy. Water injected fluorides are now the most widely abused drugs in the U.S., and it is unconscionable for the FDA to ignore the fact that clinical trials have still, after 60 years of use in some un-fortunate cities, not been submitted for review to this nation’s own U.S. FDA AND that manufacturers, and processors are still not registered with the FDA, all in direct violation of the FD&C act. It must be emphasized that we fully sympathize with and understand (we think) the FDA position, that injected fluorides in public water are not regulated drugs under FDA purview, being administered without prescription improperly, and that EPA should monitor this as though they were either contaminants or other less defined materials other than drugs. But please understand that in spite of the FDA desire for this to be so, unscrupulous individuals who ignore FDA drug protocol law are now, and have been, mass medicating populations with this chemical, regardless of its legally defined status, using the agent as though it were an approved drug for human ingestion and dispensing it with mechanisms as though they were FDA approved.
NSF certifies without authority, without human testing of any kind, the use of fluosilicic acid liquors by water districts as an agent to treat human tissue by ingestion, as requested by dental officers of the Oral Health Division office inside CDC confines (Connett ibid). The action itself of injecting waters to treat people with such chemicals is unethical and an improper use of a chemical being used as a drug, whether recognized by the FDA as a drug or not, so this is the very reason that compels the FDA to halt the injections. FDA delineated repeatedly over the years that this is an un-approved use of a drug and is fluorides are not mineral nutrients. Thus FDA must act to halt these drug-intended injections. Sodium fluoride has been largely replaced with crude hazardous waste fluosilicic acid by the unscrupulous for this mass treatment purpose, all along never having FDA approval at any time.
The original mandate of the FDA is to protect people from unapproved drugs and from toxic effects of compounds intentionally used to treat the U.S. public, who innocently place full trust in the FDA for said protection. As long as the FDA plans to never ban injected artificial toxic hazardous waste diluted fluorides from drinking water (no matter the adverse effects the injections, being used as drugs without approval or clinical trials, have on human health), and as long as FDA permanently shifts Congressional authority (for consumer protection from unapproved drug uses) away from itself, then the FDA agency remains in contradiction with itself, by not following its own drug regulations as required by its own Food Drug and Cosmetic Act. My faith and trust in the FDA was the original inspiration to send the FDA these facts in the petition in the first place, but that trust is severely tainted by the FDA response, that an MOU, rescinded by the EPA over 25 years ago, is now wished by the FDA that the EPA would finally agree to it. Either the FDA has ignored the situation for a long time, or the agency is being misinformed, or lacks sufficient communication to understand the situation. The general public has no one to address who now accepts any responsibility for the still ongoing unethical mass medication of peoples with synthetic fluorides. Most fluorides are now intentionally titrated into U.S. drinking water supplies, and this opens the door to other mass drug misuse.
The FDA Denial of Petition is Illegal and Necessitates Immediate Retraction
A. Because artificial water fluoridation is uncontrolled use of a drug (FDA attached letter), the present denial from the FDA Center for Drug Evaluation and Research carries with it the idea that as long as drug manufacturers use public water supplies, or the air or some other delivery vehicle, then drugs no longer need New Drug Applications with the FDA CDER, and can be manufactured without FDA approval! (under non-existent EPA authority).
The FDA CDER denial, if not retracted, would officially authorize drug manufacturers to formulate drugs without FDA regulatory oversight as long as the manufacturers use public water or air as the vehicle for dissemination. The FDA is saying ‘formulate fluorides, new statins, new analgesics, mood or other drugs with public water or the air, and make claims for health benefit without warning labels or side effects being listed’, all while the manufacturers are without FDA regulatory authority, because the drugs are sold for use through tap water or other mechanism.
B. Currently, public water systems, some for many decades, have been and now continue formulating misbranded, adulterated, illegal fluoride materials as anti-caries ingestible drugs. For the safety of the U.S. public, the U.S. Food and Drug Administration Center for Drug Evaluation and Research is here requested to take regulatory enforcement action.
C. The fact that the EPA has deferred all liability and regulatory authority and full permission to the States and local water districts who decide to fluoridate citizens through public waters does not carry with it the idea that people can be treated with any drug substance without FDA approval. Such substances intended for human ingestion to treat caries must be purchased from manufacturers that are registered with the FDA, who have applied for and received approval from the FDA CDER to formulate, label and sell the product for human ingestion after all requirements for a New Drug Application have been fulfilled under the U.S. Food Drug & Cosmetic Act.
PARAGRAPHS INTENDED ONLY FOR FDA REVIEWERS, NOT INTENDED FOR THE GENERAL PUBLIC, OR FOR ANY PRIVATE BUSINESS, DRUG COMPANY OR REPRESENTATIVE OF ANY KIND (unless required by FDA CFR posting regulations):
In personal discussions with drug company representatives (unnamed by desire of petitioner) in a course of training at the local medical school in San Diego, it was clearly made known of the future intention of administering selected drugs through the public water supply for those agents that are FDA approved drugs and are perceived by the manufacturer as having special status of long-term “absolute safety”, one substance in question being cholesterol-lowering statins. FDA approval was of course issued for use of statins to specifically treat bona fide hypercholesterolemia, but even then only as necessary, because no clinical trials data insure full safety from any adverse side effects after continuous use for a lifetime period. It is now however very common practice for physicians to prescribe permanent prescriptions for these agents as lifetime drugs, under the belief that such long-term clinical trials exist and that the patient has a lifetime metabolic derangement that requires it. All these mistaken beliefs above are widely held, and widely discussed. My argument to the drug representative that statins should only be used in cases of marked high ratios of LDL to HDL were ignored, with the claim that there is no known drawback to having normal cholesterol ratios lowered even further. If the FDA examines the largest prospective statin study ever conducted, in Europe with 20,000 participants, you will find that in the fine print there are as many subjects in the statin group that were spared from heart attack as were correspondingly listed accidental deaths in another group. There is no decrease in total mortality! and statins are touted as heart disease remedies, only, anyway. It is important for the FDA to realize that cholesterol depletion of brain has been documented in statin-treated subjects, and the important role of cholesterol as insulation for neurons in brain myelin affecting reaction time, mental acuity, and other possible non-understood functions was undoubtedly involved in shifting heart attack survival onto tragic accidental deaths in equal amounts.
Mass medication of an entire city or group, as is currently done with synthetic fluorides in 65% of all U.S. water supplies, simply because such a city might have a higher heart attack incidence than a control region, does not make such drug use ethical or something that should ever by approved by the FDA. Until the current FDA response was provided, this petitioner would never have discussed such a proposal in an official capacity. But now that it has been increasingly discussed as desired by drug companies, coupled with lack of FDA bans on fluosilicic acid consumption in either bottled water or as a mass medicament in public water supplies, coupled with virtually lifetime prescriptions for statin drugs now in wide, common use in broad circles of U.S. medical care, this discussion is now officially opened. Be it known at the outset that any such case of any FDA approval for mass medication (with statins or any other FDA approved drug, whether through water supplies or other form, in a manner similar to that now allowed for artificial fluoride compounds in bottled water and community water supplies), then the FDA would not be authorized to refer to itself as the FDA.
My trust in the FDA is something I could soon be unable to proclaim in good conscience to my students or the American public, but instead, it must be that the FDA will continue its Noble stance and defend the American public against unauthorized (by the FDA) use of this or any unapproved drug, as best as the FDA is able. If it simply is not possible to ban now, please consider this again in the future by re-vote of the committee, and if that is simply beyond rules, then please help us with the second consequent actions requested above in this letter.
Additional Remarks: Fluosilicic acid and sodium fluoride are both artificial synthetics and can be contaminants (when accidentally spilled into water) and, when classed as such, are illegal to intentionally inject into public drinking water under SDWA, as pointed out by the FDA response. However, these agents can also be classed drugs, and are so when intentionally injected into water and toothpaste, both to fluoridate human tissue for anti-caries purposes. The FDA has not approved artificial synthetic fluorides for ingestion, and the FDA must therefore at the present time solicit and demand clinical trials data for such uses. The FDA has now made opposite claims, a contradiction, that in public water supplies fluoride ion from artificial synthetic compounds (sodium fluoride and fluosilicic acid used in drinking water) are exclusively regulated by the SDWA as though they are not drugs and thus not an FDA responsibility. And yet FDA ruled that fluoride from such injected artificial compounds into water are an unregulated and unapproved use of a drug (FDA letter attached), which by definition is under the purview of the FDA. This latter FDA declaration has never been retracted or modified, and in fact the FDA now regulates artificial fluoride in toothpastes and other products as drugs, and wisely so.
Note that the FDA suggestion for me to contact the EPA for concerns over public drinking water injected fluorides seems to be an attempt to allow FDA to remain inactive and detached from its own required regulatory authority. The EPA clearly does not have authority or the internal expertise to regulate drugs, and for that reason refuses to regulate any artificial fluoride injections into public water supplies, as EPA has written repeatedly of its complete lack of such intent below 4 ppm. If the fluorides were to be accidentally placed into public water supplies at a level above the EPA MCL, then EPA could enforce the SDWA, but any artificial fluorides injected into public water supplies under continuous, long-term, electronically controlled, intentional conditions for human consumption to attempt to treat human tissue, is not an EPA contaminant that will be regulated by the EPA. In fact the EPA has deferred to the National Sanitation Foundation for such regulation (legal amicus statements enclosed), an agency which unfortunately also does not consider the pharmacologic actions of artificial injected fluoride compounds in any way and assumes instead that fluoride injectables, either sodium fluoride or fluosilicic acid, may be water-normalizing materials, and defers all questions of health effects and safety data to the CDC. CDC, on questioning, treats the chemical as though it were a supplement benefit for teeth tissue, but admits it also has no authority to regulate, nor has personnel trained or equipped to regulate, any drug or supplement in the United States. Such regulation is the sole jurisdiction of the U.S. FDA.
Finally, proof of the latter statement is found in the long-standing discussions in the FDA Code of Federal Regulations regarding water fluoride, either found naturally in, or which are intentionally added into, bottled water that is subject to regulation by the FDA. Although a ban request for bottled water artificial fluorides are outside the scope of the petition and this rebuttal, the following statements are needed regarding bottled water fluorides, for clear understanding of the present petition regarding fluosilicic acid and other artificial fluorides sold for human ingestion widely for use as a putative anti-caries agent. To avoid confusion among the general public, while being as polite as possible, bottled water that has been treated with synthetic artificial fluorides should be properly labeled. Artificial fluorides that are intentionally added to bottled water are usually present by bottling water from municipal tap water that has been treated with either sodium fluoride or fluosilicic acid fluoride (not the natural non-toxic compound calcium fluoride), or by intentionally adding the synthetic materials prior to bottling non-fluoridated regular water. Bottled water treated with synthetic fluorides, not being natural water, should be labeled in a manner similar to the following:
”The Safe Drinking Water Act prohibits adding drugs or contaminants into U.S. drinking water. The U.S. FDA does not recognize fluorides as mineral nutrients. This product contains added synthetic fluoride to 0.8 – 1 mg/liter.”
Conclusion: We trust that the information contained herein, when taken together in its entirety, will fully clarify for and convince the FDA to institute a ban on the sale of artificial fluoride compounds to be used for human ingestion in the U.S. and/or to halt the sale from such establishments that manufacture artificial fluoride compounds for human ingestion as purported anti-caries ingestibles, while valid clinical trials data are completed and submitted to the FDA for a New Drug Application as required in CFR 21. The action is particularly important for fluoride because, like arsenic and certain other contaminants of comparable acute toxicity level, the fluoride ion accumulates during lifetime continuous ingestion. FDA-required clinical trials data are a necessary minimum, but, as for any drug, such trials only apply to relatively short duration ingestion for which the trial period is conducted. Permanent, continuous-daily ingestion lifetime of any unnatural substance that is not a mineral nutrient cannot be said to have ever been proven to be safe for any or all consumers through such trials. This problem is significant for any drug taken for very extended time periods, but is most problematic for long-term ingested artificial substances that are known to accumulate permanently in human tissue lifetime, as does the fluoride ion from all its ingested sources.
I am here to help the FDA in any way I possibly can with actions necessary to honor this petition as expeditiously as possible. The honorable States of Oregon and Nebraska have officially banned artificial fluorides from public drinking waters, and the entire American public also deserves such protection.
The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petition which are unfavorable to the petition.
Respectfully yours,
Richard Sauerheber, Ph.D., Chemistry,
and the United States citizens this petition FDA-2007-P-0346 represents
Enclosed: FDA letters1963 and 2000; New Jersey State Legislature letter 1993; New Jersey Assembly letter 1995; Soft Drink Asso. letter 2000; Solvay water treatment request letter 2007; Solvay response letter 2007; CA DHS and the Los Angeles Metropolitan Water District letters and legal amicus for WA litigation; public FDA information Orange book; EPA letter to Osmunson 2010; Pace University School of Law letter 1997; excerpts from Connett, et.al. Chaps. 4, 5,6,9; excerpts from NSF International, Thiessen letter to EPA; Colgate Palmolive public information; Heard letter 1954.
| Active Ingredient Search Results from “OB_OTC” table for query on “fluoride.” Appl No |
RLD | Active Ingredient |
Dosage Form; Route |
Strength | Proprietary Name |
Applicant |
| N020231 | Yes | SODIUM FLUORIDE; TRICLOSAN | PASTE; DENTAL | 0.24%;0.3% | COLGATE TOTAL | COLGATE PALMOLIVE |
Relevant portions of transcripts of legal documents in ongoing litigation with the Metropolitan Water District, Los Angeles, CA:
To date, no manufacturer of hydrofluosilicic acid under request will state that their specific product is safe and effective at fulfilling fluoridation’s legislative intent
In example: attached is a May 9, 2007 request from the Chair of the Poughkeepsie Joint Water Board in New York State to Solvay, LLC, their supplier of hydrofluosilicic acid:
“To assure that this Board has selected a product that is consistent with the legislative intent of safely and effectively reducing the incidence of tooth decay, we request that you or some entity in the chain of delivery provide us with the following declaration for your fluosilicic product:
“This specific product, as it is constituted and inclusive of contaminants, is effective at reducing the incidence of tooth decay when ingested in dilution amounts consistent with fluoridation goals of 0.7 to 1.2 milligrams of fluoride ion per liter, and is safe for the full range of expected human consumption at these dilution ranges, without known or anticipated adverse health effects over a lifetime, including for infants, children, the elderly, and other populations afforded equal protection.”
Please state Yes if each shipment of your product can be accompanied by the above declaration as a condition of purchase.
Please state No if you, or any other entity in the chain of delivery, are not able to make this declaration for your product.
As the attached July 19, 2007 response by Solvay reveals, Solvay ignores the directed questions posed about their own product, and request for pertinent documents including toxicological and proof of meeting Standard 60, and directs their client water district to contact the CDC, which by law cannot represent a manufacturer.
No government body or promoter of fluoridation can identify a chronic toxicological study on hydrofluosilicic acid, with or without the attendant contaminants
Response to Congressional investigation by House Committee on Science on fluoride when U.S. EPA was asked to identify scientific data on sodium silicofluoride and hydrofluosilicic acid: “In collecting data for the fact sheet, EPA was not able to identify chronic studies on those chemicals.”
Robert C. Thurnau, Chief, Treatment Technology Evaluation Branch, Water Supply and Water Resources Division, U.S. EPA National Risk Management Research Laboratory, November 16, 2000, “To answer your first question of whether we have in our possession any empirical scientific data on the effects of fluosilicic acid or sodium silicofluoride on health and behavior, the answer is no.”
Disseminating information including safety and effectiveness claims for the addition of hydrofluosilicic acid to drinking water without revealing that there are no toxicological studies on the health and behavioral effects of the substance is a misrepresentation and omission of material fact.
Manufacturers of hydrofluosilicic acid are not compliant with State requirements
Title 22 CCR, Chapter 18 Drinking Water Additives, Article 1 Requirements Section 64700. Direct Additives: “(a) No chemical or product shall be added to drinking water by a water supplier as part of the treatment process after January 1, 1994 unless the chemical or product has been tested and certified as meeting the specifications of American National Standard Institute/National Sanitation Foundation Standard 60, ANSI/NSF60, as amended October 1988 (drinking water treatment chemicals-health effects). This requirement shall be met under testing conducted by a product certification organization accredited for this purpose by the American National Standards Institute.”
In a July 7, 2000 response by NSF International to Congressional investigation by the U.S. House Committee on Science, and subsequent confirmation in a March 10, 2004 under-oath deposition testimony by the author of the response, Stan Hazan, NSF indicates that, despite certification, no manufacturer of fluoridation chemicals has fully complied with ANSI/NSF Standard 60 General Requirement 3.2.1 even under the Business Confidentiality Act. Thus any certification of the manufacturer for purposes of delivering fluoridation chemicals is not a reliable source for verification; and as NSF has previously and continuously provided certifications with knowledge that the manufacturers had not met these certain requirements as published, any statement by NSF would be suspect without specific dated, true and correct copies of documents as proof.
Non-compliance with Section 3.2.1 is not a minor oversight. Further NSF Standard 60 requirements for testing and assessment are dependent on the specific data provided by the manufacturer in this section. In order to be certified by NSF that the manufacturer is in compliance with Standard 60, this section includes the requirements that a manufacturer shall submit a list of known or suspected impurities within the treatment chemical formulation and the maximum percent or parts by weight of each impurity, and a list of toxicological data, both published and unpublished if available, on the manufacturer’s product, and all of its components, including any and all contaminants present. There are no published exceptions to this General Requirement, which is published by NSF as uniformly applied to all direct water additives.
NSF’s statement of omission of this critical data from every manufacturer of fluoridation chemicals reinforces the statutory necessity for the owner/operator of the municipal residential drinking-water system to confirm compliance from the specific chemical provider.
In addition to the manufacturer/producer, ANSI/NSF Standard 60 also requires other entities in the chain of delivery of a product, including re-packagers, to conform to General Requirements and annual inspection.
NSF is not able to discharge any responsibility of the manufacturer or any other party
NSF International is not a government agency, and has no duty of care to consumers.
NSF Disclaimer: “NSF, in performing its functions in accordance with its objectives, does not assume or undertake to discharge any responsibility of the manufacturer or any other party.”
EPA and CDC are misrepresented as controlling authority for safety of hydrofluosilicic acid; no federal safety standards for direct water additives
Any statement or inference that hydrofluosilicic acid meets EPA or any other federal agency safety standard is a misrepresentation and omission of fact.
U.S. Maximum Contaminant Levels (MCLs) and California MCLs are not safety standards for direct water added chemicals.
MCLs are concentration points for specific contaminants at which the water operator is to limit a contaminant’s concentration in the public drinking water or remediate the excess. MCL’s are negotiated with consideration for the availability of methodology and unique costs of measuring and removing the contaminant from source water. They are not an invitation to “fill ‘er up”.
Hydrofluosilicic acid is a direct water added chemical. It does not occur in water naturally in its commercially available form, and is processed by the phosphate fertilizer industry without any federal quality control for safety or effectiveness of the product. Natural fluoride is accompanied with calcium, while synthetic fluorides injected into water contain no calcium.
On July 7, 1988, by Notice in the Federal Register (53 FR, 25586), U.S. EPA terminated oversight responsibilities for water additives, which at that time was limited to an informal advisory role, in favor of industry-established standards which individual states or water suppliers are free to adopt.
Tudor T. Davies, Director, Office of Science and Technology, U.S. EPA, states in a letter to George Glasser on April 2, 1998, “In the U.S., there are no Federal safety standards which are applicable to drinking water additives, including those intended for use in fluoridating water.”
Statements of safety and effectiveness of hydrofluosilicic acid, coming from, or attributed to, Centers for Disease Control are equally misrepresentative, as the CDC has no authority from Congress to determine or endorse the safety or effectiveness of any direct water additive.
Congress has defined a drug as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles intended to affect the structure or any function of the body of man.” (21 U.S.C. §321)
Congress has ordered and the United States Food and Drug Administration (U.S. FDA) has replied to Congressional investigation that the FDA is the only government agency with the authority to approve or reject any claim of safety or effectiveness for any product that is intended to cure, mitigate, treat or prevent any disease in man.
Promoters of fluoridation and legislative bodies have attempted to circumvent this status by restricting their claims of safety and effectiveness to the public policy. Any statement that a specific manufacturer’s hydrofluosilicic acid is safe and effective thrusts that claim into the jurisdiction of the FDA and requires approval for such claim.
Claims of authority derived from a 1979 Memorandum of Understanding (MOU) between the U.S EPA and U.S. FDA, in which the two parties appear to agree that U.S. EPA will perform duties concerning water additives, did at no time address water additives intended to perform as medication, treatment, prevention, or in any manner as drug, so was never on point for the issue of substances intended to treat humans rather than the water.
The 1979 MOU is further not controlling, and non-operative for U.S. EPA’s jurisdiction over direct water additives, as U.S. EPA terminated its informal advisory function on additives that was essential to the MOU Terms of Agreement.
Legal actions confirm U.S. Food and Drug Administration authority over safety and effectiveness of a product
The U.S. Supreme Court has confirmed that it is Congress and the language of the statute that controls the jurisdiction of the FDA Act, not a statement by an agency or another governmental entity. FDA v. Brown & Williamson, (529 U.S. 120 (2000)).
In a December 2003 decision of widespread importance, the U.S. District Court ruled, and was not challenged, that even the U.S. government under emergency conditions of war cannot force an individual to be medicated with a substance that has not been specifically approved for the purpose it is intended, and especially approved in the manner it is administered.
The Court ruled that the approval of one substance, or manner of delivery, does not translate to an approval of another similar substance or different mode of delivery.
The Court clarified that the fact that the use of the anthrax vaccine was also subject to action by the FDA, and that the FDA had not taken action, did not refute the relevancy of the evidence that the drug was not approved by the FDA, and thus was “arbitrary” and therefore could not be sustained. (Doe v. Rumsfield, 2003 U.S. Dist. LEXIS 22990 December 22, 2003)
FDA states in their 2000 response to Congressional investigation on fluoride: “Fluoride, when used in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal, is a drug that is subject to FDA regulation,” and that no fluorine-containing product intended for ingestion for the purpose of reducing tooth decay has ever been approved for safety and effectiveness.
Excerpt from legal amicus by Attorney James Robert Deal available online at: http://fluoride-class-action.com/bd-of-health/amicus-letter/amicus-letter-doc to download this letter
The silicofluorides that most high capacity water districts buy are produced in super-phosphate fertilizer plants, mainly in Florida and Louisiana, but also in China and other countries. Phosphate rock and sulfuric acid are cooked together. The fumes go up the stack. Before 1979 the smoke escaped to poison the surrounding countryside, killing plants, animals, and people. Today that smoke is captured in wet scrubbers built into the smokestacks. The liquid which captures the smoke is called “scrubber liquor.” Unfiltered and unrefined, scrubber liquor is pumped into tanker trucks and delivered to the headwaters of our rivers where it is discharged into our drinking water. Toxic material which is illegal to discharge into air is captured in scrubber liquor, which is illegal to discharge into lakes, rivers, or seas, but which can be discharged into our drinking water. It is absurd when you think about it.
Nothing good can be said about the super-phosphate fertilizer industry. Only 30 percent of super-phosphate fertilizer applied to corn, soy, wheat, or cotton is absorbed by plants. The remaining 70 percent builds up in the soil and stunts microbial life. Sufficient phosphate is present in most soils; pH only need be adjusted to between 5.5 and 7.0 to make it available. If soil is deficient in phosphorus, the way to add it is the way organic farmers add it: to mix raw phosphate rock with animal or vegetable manure and compost it. Organic phosphate is long lasting and keeps soil healthy for microbes.
Super-phosphate fertilizer plants are surrounded by miles of toxic waste “gypsum stacks.” Gypsum stacks can be a hundred feet high. They encircle evaporation ponds which contain vast quantities of scrubber liquor. Scrubber liquor dries and hardens into white pebbles, which are dredged out of the ponds into the surrounding gypsum stacks. These silicofluorides are unusable in industry because the silicon is hard to remove. The pebbles cannot be used to gravel roads because they are radioactive. If the companies which build these giant piles were required to clean them up or restore the land, the companies would immediately be bankrupt. Such a task would be impossible. These are permanent sacrifice zones. The super-phosphate industry is unnecessary and destructive.
When fluoridation began in the 1940s only sodium fluoride was used. All early fluoridation tests on humans and animals were done and have almost always been done using pharmaceutical grade sodium fluoride. Although neither type of fluoridation material is safe for internal consumption, there are clear indications that fluosilicic acid preparations which are classed by the EPA s a toxic hazardous waste are worse than sodium fluoride [and contain diverse toxic contaminants and are re-labeled outside public view as ‘fluoride’ for sale for use as an anti caries ingestible material which constitutes misbranding of a drug substance].
(c) For each drug product listed that is subject to the imprinting requirements of part 206 of this chapter, including products that are exempted under 206.7(b), drug companies must submit a document that provides the name of the product, its active ingredient(s), dosage strength, National Drug Code number, the name of its manufacturer or distributor, its size, shape, color, and code imprint (if any), and any other characteristic that identifies the product as unique. On June 16, 2006, the FDA received a notification (the June 16 notification) from the law firm of Covington and Burling regarding a health claim for the relationship between fluoridated water and a reduced risk of dental caries. The 120-day period from the date of submission of the June 16 notification was October 14, 2006. Therefore, after October 14, 2006, manufacturers may use the claim specified in the notification, as modified by the notifier in a letter to FDA dated October 13, on the label and in labeling of any food product that meets the eligibility criteria described below, unless or until FDA or a court acts to prohibit the claim.
Claims of Effectiveness by Endorsement, for FDA approval without proper clinical trials data.
The June 16 notification cites statements from several sources as authoritative statements for the claim. FDA reviewed the sources and cited statements in their context and in light of existing authorized health claims and current science. The following three statements are considered authoritative for purposes of this notification.
Recommendation for Using Fluoride to Prevent and Control Dental Caries in the U.S. (Centers for Disease Control, 2001):
“Widespread use of fluoride has been a major factor in the decline in the prevalence and severity of dental caries (i.e., tooth decay) in the United States and other economically developed countries. When used appropriately, fluoride is both safe and effective in preventing and controlling dental caries. All U.S. residents are likely exposed to some degree of fluoride, which is available from multiple sources.” (Summary section, page 1)
“Continue and extend fluoridation of community drinking water: Community water fluoridation is a safe, effective, and inexpensive way to prevent dental caries. This modality benefits persons in all age groups and of all SES, ….” (Recommendation section, page 24)
Oral Health in America: A Report of the Surgeon General (2000):
“Community water fluoridation is safe and effective in preventing dental caries in both children and adults. Water fluoridation benefits all residents served by community water supplies regardless of their social or economic status. Professional and individual measures, including the use of fluoride mouth rinses, gels, dentifrices, and dietary supplements and the application of dental sealants, are additional means of preventing dental caries.” (Executive summary)
Review of Fluoride: Benefits and Risks (Public Health Service, 1991):
“Extensive studies over the past 50 years have established that individuals whose drinking water is fluoridated show a reduction in dental caries. Although the comparative degree of measurable benefit has been reduced recently as other fluoride sources have become available in non-fluoride areas, the benefits of water fluoridation are still clearly evident.” (Conclusions section, page 87)
According to the June 16 notification and the letter to FDA dated October 13, the food eligible to bear the claim is bottled water meeting the standards of identity and quality set forth in 21 CFR 165.110, containing greater than 0.6 and up to 1.0 mg/L total fluoride, and meeting all general requirements for health claims (21 CFR 101.14) with the exception of minimum nutrient contribution (21 CFR 101.14 (e)(6)). The claim language is: “Drinking fluoridated water may reduce the risk of [dental caries or tooth decay].” In addition, the health claim is not intended for use on bottled water products specifically marketed for use by infants.
21 CFR § 165.110. This section establishes a standard of identity and a standard of quality for bottled water. Under the standard of identity (165.110[a]), FDA describes bottled water as water that is intended for human consumption and that is sealed in bottles or other containers with no added ingredients except that it may contain safe and suitable antimicrobial agents. Fluoride also may be added within the limits set by the FDA. The name of the food is “bottled water” or “drinking water.”
Pace Environmental Law Review
Volume 14, Number 2 Summer 1997
Copyright © 1997 by Pace University School of Law. All rights reserved
reprinted here with permission
Fluoridation of Public Water Systems:
Valid Exercise of State Police Power or Constitutional Violation?
United State Supreme Court Stance on Unwanted Medical Treatment
In Cruzan v. Director, Missouri Department of Health,283 the United States Supreme Court stated that although many state courts have analyzed the right to refuse medical treatment under the implied constitutional right of privacy, it “is more properly analyzed in terms of a Fourteenth Amendment liberty interest.”284 In Cruzan, the Supreme Court acknowledged that “[t]he principle that a competent person has a constitutionally protected liberty interest in refusing unwanted medical treatment may be inferred from our prior decisions.”285 Additionally, the Supreme Court assumed that the Constitution would grant a person “a constitutionally protected right to refuse lifesaving hydration and nutrition.”286 In a prior case, the Supreme Court held that “[t]he forcible injection of medication into a nonconsenting person’s body represents a substantial interference with that person’s liberty.”287 However, the court also recognized that while a person has a liberty interest under the Fourteenth Amendment Due Process Clause, whether the person’s “constitutional rights have been violated must be determined by balancing his liberty interests against the relevant state interests.”288 This “relevant” state interest, also referred to as a “compelling” state interest,289 is one which the state is forced or obliged to protect.290 While all states have a compelling interest to prevent contagious diseases, such as the spread of smallpox in Jacobson v. Massachusetts, 291 tooth decay is not contagious, poses no risk of an outbreak, and thus is not a compelling interest such as would require state intervention. Accordingly, courts should apply a strict scrutiny standard of review when balancing a substantial liberty interest against fluoridation, which is, in effect, merely a state-mandated prophylactic measure for a noncontagious disease. A strict scrutiny standard requires that a state have a compelling interest to enact legislation, and that such legislation be narrowly tailored to achieve its purpose so as not to infringe on personal liberty interests protected by the Constitution.292
There is clearly no right or compelling interest for the federal government to mandate fluoridation of drinking water because it is known that fluoride is a contaminant which may have an adverse affect on the health of persons.293 If states were bound by the Safe Water Drinking Act, then they would be prohibited from requiring fluoridation of the public water systems, despite their police power. This state police power is supposed to be used to promote the general health and welfare of the public, and should not be used as authority to purposely add contaminants into public drinking water. While reasonable minds may differ about whether the state’s interest in health encompasses non-contagious diseases and whether this interest is compelling, fluoridation of public water systems does not pass constitutional muster because it fails the second prong of the strict scrutiny test: it is not narrowly tailored to achieve the legislature’s purpose, and reasonable alternatives exist.
V. Conclusion
It is incumbent upon the United States Supreme Court to grant certiorari to the next fluoridation challenge brought based upon a due process violation of an individual’s liberty interest. Whereas the Supreme Court has yet to resolve the issue of whether fluoridation invades a constitutionally protected interest when the state mandates the ingestion of a prophylactic drug to prevent a noncontagious disease, the Court has held, however, that a state may exercise its police power to protect the public from the spread of contagious disease. This distinction between contagious and noncontagious disease is critical because it determines the extent of the state interest when balancing the right of an individual to be free from compulsory medication against the state interest in attempting to prevent tooth decay by fluoridating public water systems.
The holding in Washington v. Harper294 reflects the modern Supreme Court position, whereby “[t]he forcible injection of medication into a nonconsenting person’s body represents a substantial interference with that person’s liberty.”295 However, this holding is qualified by the caveat that whether this constitutionally protected liberty interest has been violated “must be determined by balancing that liberty interest against the relevant state interests.”296 The balancing is accomplished by subjecting fluoridation statutes to a strict scrutiny review in order to determine if they pass constitutional muster.
Because there is no compelling state interest to mandate prophylactic drugs for a noncontagious disease, the means of accomplishing the legislature’s goals is not narrowly tailored, and reasonable alternatives exist, fluoridation statutes will fail the strict scrutiny test. Pursuant to the holdings in Harper and Cruzan, it is reasonably certain that fluoridation of public water systems will eventually be deemed a substantial invasion of personal liberty in violation of the Constitution of the United States of America.
Fluoridating public water in an attempt to target children whose permanent teeth are still developing is like using a shotgun to shoot an apple off someone’s head; sure, you hit the apple, but the side effects are undesirable.
Service
Food and Drug Administration Rockville MD 20857
DEC 21 2000
The Honorable Ken Calvert Chairman Subcommittee on Energy and Environment Committee on Science House of Representatives Washington, D.C. 20515-6301
Dear Mr. Chairman:
Thank you for the letter of May 8, 2000, to Dr. Jane E. Henney, Commissioner of Food and Drugs, regarding the use of fluoride in drinking water and drug products. We apologize for the delay in responding to you.
We have restated each of your questions, followed by our response.
1. If health claims are made for fluoride-containing products (e.g. that they reduce dental caries incidence or reduce pathology from osteoporosis), do such claims mandate that the fluoride-containing product be considered a drug, and thus subject the product to applicable regulatory controls?
Fluoride, when used in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal, is a drug that is subject to Food and Drug Administration (FDA) regulation. FDA published a final rule on October 6, 1995, for anticaries drug products for over-the-counter (OTC) human use (copy enclosed). This rule establishes the conditions under which OTC anticaries drug products are generally recognized as safe and effective and not misbranded. The rule has provisions for active ingredients, packaging conditions, labeling, and testing procedures that are required by manufacturers in order to market anticaries products. A new drug application (NDA) may be filed for a product containing fluoride that does not meet the provisions stated in the final rule. As you know, the Environmental Protection Agency regulates fluoride in the water supply.
Page 2 – The Honorable Ken Calvert
2. Are there any New Drug Applications (NDA) on file, that have been approved, or that have been rejected, that involve a fluoride-containing product (including fluoride-containing vitamin products) intended for ingestion with the stated aim of reducing dental caries? If any such NDA’s have been rejected, on what grounds were they rejected? If any such NDA have been approved, please provide the data on safety and efficacy that FDA found persuasive.
No NDAs have been approved or rejected for fluoride drugs meant for ingestion. Several NDAs have been approved for fluoride topical products such as dentifrices and gels. Fluoride products in the form of liquid and tablets meant for ingestion were in use prior to enactment of the Kefauver-Harris Amendments (Drug Amendments of 1962) to the Food, Drug, and Cosmetic Act in which efficacy became a requirement, in addition to safety, for drugs marketed in the United States (U.S.). Drugs in use prior to 1962 are being reviewed under a process known as the drug efficacy study implementation (DESI). The DESI review of fluoride-containing products has not been completed.
3. Does FDA consider dental fluorosis a sign of over exposure to fluoride?
Dental fluorosis is indicative of greater than optimal ingestion of fluoride. In 1988, the U.S. Surgeon General reported that dental fluorosis, while not a desirable condition, should be considered a cosmetic effect rather than an adverse health effect. Surgeon General M. Joycelyn Elders reaffirmed this position in 1994.
4. Does FDA have any action-level or other regulatory restriction or policy statement on fluoride exposure aimed at minimizing chronic toxicity in adults or children?
The monograph for OTC anticaries drug products sets acceptable concentrations for fluoride dentifrices, gels and rinses (all for topical use only). This monograph also describes the acceptable dosing regimens and labeling including warnings and directions for use. FDA’s principal safety concern regarding fluoride in OTC drugs is the incidence of fluorosis in
Page 3 – The Honorable Ken Calvert
children. Children under two years of age do not have control of their swallowing reflex and do not have the skills to expectorate toothpaste properly. Young children are most susceptible to mild fluorosis as a result of improper use and swallowing of a fluoride toothpaste. These concerns are addressed in the monograph by mandating maximum concentrations, labeling that specifies directions for use and age restrictions, and package size limits.
Thanks again for contacting us concerning this matter. If you have further questions, please let us know.
Melinda K. Plaisier Associate Commissioner for Legislation
Enclosure —Final Rule/Federal Register – October 6, 1995 Over-the-Counter Anticaries Drug Products“
Official statues that apply to fluosilicic acid and sodium fluoride, when used for oral ingestion as anti-caries agents, in cases assumed to be either legend drugs or experimental drugs, whether disseminated through public tap water, commercial bottled water, or other means of dispensation, from typical U.S. State regulations developed from the Code of Federal Regulations, U.S. FDA (artificial fluorides are NOT supplements, mineral nutrients, or additives that sanitize water, but are intended for use as drugs):
Any drug or device is adulterated if the methods, facilities, or controls used for its manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with current good manufacturing practice to assure that the drug or device meets the requirements of this part as to safety and has the identity and strength, and meets the quality and purity characteristics that it purports or is represented to possess.
Any drug is adulterated if it purports to be, or is represented as, a drug that is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standards set forth in the compendium.
Any drug is misbranded unless its label bears, to the exclusion of any other nonproprietary name except the applicable, systematic chemical name or the chemical formula, all of the following information:
(1) The established name of the drug, if any.
(2) If it is fabricated from two or more ingredients, the established name and quantity of each active ingredient.
For nonprescription drugs, the quantity or proportion of each active ingredient and the established name of each inactive ingredient in accordance with Sections 502(e)(1)(A)(ii) and (iii) of the Federal act (21 U.S.C. 352(e)(1)(A)(ii) and (iii)).
Any drug or device is misbranded unless its labeling bears all of the following information:
(a) Adequate directions for use.
(b) Such adequate warnings against use in pathological conditions
or by children where its use may be dangerous to health.
(c) Adequate warning against unsafe dosage or methods or duration
of administration or application.
Any drug is misbranded if it purports to be a drug that is recognized in an official compendium and it is not packaged and labeled as prescribed in the official compendium. The method of packaging, however, may be modified with the consent of the
department.
Any drug is misbranded in any of the following cases:
(a) It is an imitation of another drug.
(b) It is offered for sale under the name of another drug.
(c) The contents of the original package have been, wholly or
partly, removed and replaced with other material in the package.
Any drug is misbranded in any of the following cases:
(a) It is an imitation of another drug.
(b) It is offered for sale under the name of another drug.
(c) The contents of the original package have been, wholly or
partly, removed and replaced with other material in the package.
A drug or device is misbranded if it was manufactured in an establishment not duly registered with the Secretary of Health, Education, and Welfare of the United States.
It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any drug or device that is misbranded.
A drug or device is deemed misbranded if it is subject to regulations issued by the United States Food and Drug Administration relating to tamper-resistant packaging, as set forth in Parts 200, 211, 314, and 800 of Volume 21 of the Code of Federal Regulations, as amended, but is not in compliance therewith.
The following statutes apply if it is deemed instead that fluosiilcic acid and sodium fluoride are experimental drugs:
Prior to administering an experimental drug, the experimental activity as a whole, including the consent procedures required by Section 111525, shall be reviewed and approved by a committee for the protection of human subjects that is acceptable, as
determined by the department. A committee for the protection of human subjects that operates under a general or special assurance approved by the federal Department of Health, Education, and Welfare pursuant to Part 46 of Title 45 of the Code of Federal Regulations shall be an acceptable committee for purposes of this section. A copy
of the consent procedures approved by a committee for the protection of human subjects shall be filed with the department prior to the commencement of the experiment.
No person shall sell, deliver, or give away any new drug or new device unless it satisfies either of the following:
(a) It is a new drug, and a new drug application has been approved
for it and that approval has not been withdrawn, terminated, or suspended under Section 505 of the federal act (21 U.S.C. Sec. 355); or it is a new device for which a premarket approval application has been approved, and that approval has not been withdrawn, terminated, or suspended under Section 515 of the federal act (21 U.S.C. Sec. 360e).
http://www.leginfo.ca.gov/cgi-bin/calawquery?codesection=hsc&codebody=&hits=20
Drug Manufacturer’s License
New Drug Manufacturing License Application (CDPH 52N) (PDF)
Dr. Bill Osmunson,
I have answered your questions in red below.
Thanks,
Mark D. Johnston
from: Bill [mailto:bill@teachingsmiles.com]
Sent: Friday, October 09, 2009 3:05 PM
To: Mark D. Johnston
Subject: RE: Request for Affidavit
Dear Mark,
Thank you for your response and I understand the Board has not taken independent action on sodium fluoride.
Would the BOP be able to respond to the questions,
“Is the ingestion of sodium fluoride with the intent to prevent dental decay considered a prescription drug in Idaho?” Idaho hasn’t taken any action to denominate fluoride as a prescription drug.
“Do I need to register or license my sodium fluoride drug manufacturing facility in Idaho?” If the manufacturing facility is located in Idaho, then it does need to be licensed under Idaho Code Title 54, Chapter 17. Even though there apparently has not been any federal or state action to make fluoride a “prescription” drug, it is still a “drug.” Idaho Code 54-1705(7) (b), (c).
(7) Drug means:
(b) Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animal;
(c) Articles, other than food, intended to affect the structure or any function of the body of man or other animals.”
Under Idaho Code 54-1705(9), “’drug outlet’” means all pharmacies . . . manufacturers . . . with facilities located in this state which are engaged in dispensing, delivery or distribution of drugs . . .” Idaho Code 54-1729 requires drug outlets to be licensed annually.
Sincerely,
Bill
Bill Osmunson DDS, MPH
From: Mark D. Johnston [mailto:Mark.Johnston@bop.idaho.gov]
Sent: Friday, October 09, 2009 8:51 AM
To: bill@teachingsmiles.com
Subject: FW: Request for Affidavit
Dear Mr. and Mrs. Osmunson,
I’m in receipt of your request, e-mailed on 9/19/09. I am unable to provide an affidavit as you request under statute 54-1738(3), Idaho code, as the Idaho Board of Pharmacy has no such record that shows that the Board has taken action independently of federal law to designate or denominate the drugs sodium fluoride, silicofluoride, and/or hydrofluorosilicic acid as prescription drugs.
Sincerely yours,
Mark Johnston
From: Mark D. Johnston
Sent: Tuesday, September 29, 2009 7:57 PM
To: ‘Bill’
Subject: RE: Request for Affidavit
From: Bill [mailto:bill@teachingsmiles.com]
Sent: Saturday, September 19, 2009 8:17 PM
To: Mark D. Johnston
Subject: Request for Affidavit
Importance: High
Rosemarie and Bill Osmunson DDS, MPH
54 Ponder Point
Sandpoint, Idaho 83864
September 19, 2009
Mark Johnston, R.Ph.~ Mark.Johnston@bop.idaho.gov
Executive Director
Idaho Board of Pharmacy
3380 Americana Terrace, Suite 320
Boise, ID 83706
Phone (208) 334-2356
FAX (208) 334-3536
P.O. Box 83720
Boise, ID 83720-0067
Dear Mark Johnston:
RE: Idaho Statute 54-1738. Request for affidavit.
This is a request for an affidavit from an officer having legal custody of the records of the state board of pharmacy, stating that records of the board of pharmacy show sodium fluoride, silicofluoride, and/or hydrofluorosilicic acid when systemically used with the intent to mitigate or prevent dental decay have been denominated a prescription drug. And please attach a copy of the official document evidencing such action.
The FDA was asked whether those fluoride substances were approved drugs and the FDA responded:
“Thank you for writing the Division of Drug Information, in the FDA’s Center for Drug Evaluation and Research.
A search of the Drugs@FDA database
(http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm) of approved drug products and the Electronic Orange Book
Dear U.S Environmental Protection Agency,
Please re-examine the pdf report published by the EPA recently on non-cancer effects of water fluoride consumption. Understand for example that the Taiwan study (Chen, 1989) detected significant tooth fluorosis in children raised on water with fluoride ion between 0.4 – 0.7 ppm, with incidences ranging from 14 to 33% (100 – 86 = 14% and 100 – 68 = 32%). This is consistent with the best data we have from our most massive study (described in Connett, et. al. “The Case Against Fluoride”, 2010), where any water level from 0.3 ppm or higher usually causes significant tooth fluorosis (which is abnormal enamel caused, we now believe, by fluoride inhibition of the required enzymatic removal of protein from sites of enamel hardening), the first visible sign of fluoride overdose (Groth, E., World Book; Connett, 2010).
Any recommendation from the EPA to allow or promote injections of synthetic water soluble fluorides (all with low LD50 single doses in experimental animals of 125 ppm, blood lethal level of 3-5 ppm, compared to natural insoluble calcium fluoride with a safe high oral acute LD50 of 3,000 ppm) into public water supplies to 0.7 ppm will increase the incidence of tooth fluorosis in resident children. Such a recommendation represents a complete reversal of the original mission of the U.S. EPA, which is to protect the public from environmental harm. It is also a violation of the original Congressional approved mandates of the U.S. Safe Drinking Water Act, which prohibits any Federal requirement of an amount of any substance to treat water (whether a beneficial food, or a drug with potential side effects) other than to sanitize the water. The addition of fluorides into water, which purposes to treat human tissue, is thus illegal and the EPA should be ashamed of investigating such a possibility.
Fluoridation has been allowed by the EPA in recent times and has caused the inclusion of added regulations, not approved by the U.S. Congress, into the SDWA to prevent punative measures against States that treat their citizens with this substance in water. It is time to end these allowances, rather than to extend even further from the law and actually recommend a Federal level of this agent as a tissue treatment that has never been approved for oral ingestion by the U.S. FDA.
For modern data see the report from Dr. Kathleen Thiessen, Oak Ridge Laboratories (see reference below) and data from the Adelaide Dental research group in Australia (enclosed). These data all confirm conclusively that fluoride consumption from water at 0.3 ppm or above DOES NOT reduce dental caries, but instead causes significant abnormal dental fluorosis. The notion of the EPA presented in the introduction of its pdf report is false, that the old Dean study “proved” there is a dose at which caries are reduced from oral ingestion of fluorides. This myth has been widely parroted but never actually found by experiment. In fact quite the contrary. The data from NIDR (Hileman, Chemical and Engineering News, 1985; Connett, 2010), from Osmunson (Spittle, Fluoride Fatigue; FDA petition 2007-P-0346 attached), from Australia and Thiessen, and many other sources prove cavity incidence is not significantly lowered in children raised with fluoridated water (www.fluoridealert.org).
Finally, in a most stunning finding, the NRC Report (2006) found that fluoride in saliva from water containing 1 ppm fluoride is present as a blood filtrate at only 0.02 ppm, unable to influence teeth topical surfaces–period. High levels of topical fluoride are now argued still to be effective when present at 1,500 ppm in toothpastes and other external topical prophylactics not to be swallowed, but the old idea that ingested fluoride may have such effects, based on the original Dean data in communities with NATURAL (not injected synthetic) fluoride, is discredited (CDC, Morbidity and Mortality Weekly Report, Aug. 19, 2001).
It is long past time to ban artificial injections of unnatural synthetic fluoride compounds, in particular the highly water soluble diluted hazardous waste fluosilicic acid, into public water supplies, as has been requested in petitions to the FDA, EPA and CDC. The injections are harmful, do not decrease caries incidence (see FDA petition P2007-0346 please see attachment), are illegal and costly. If there is any Government program that should be listed for funding cuts to minimize our current financial debt crisis, toxic calcium-chelating synthetic fluorides being used as though they are useful drugs must be on top of that list. Taxpayers pay for health and normal regular drinking water without injected drugs or unnecessary substances, and expect the EPA to provide assistance. This request is fully consistent with and backed up by Section 101a of the Federal Water Pollution Control Act, with the stated mission to maintain the natural chemistry of U.S. water supplies. This act was first conceived by our late President John F, Kennedy, and it has now become necessary, due to widespread false information to the contrary, for the EPA to actively help the country follow this true environmental principle.
Thank you for your attention,
Richard Sauerheber, Ph.D., Chemistry, University of CA, San Diego
currently Palomar College, San Marcos, CA
1. Dr. Thiessen data proving fluoride ingestion from water does not decrease caries but instead increases tooth fluorosis to varying degree (depending on prevailing calcium content in the water that is not regulated when fluorides are injected). www.fluoridealert.org/re/thiessen.canada.2009.pdf
2. FDA petition response attachment (one section in this detailed response to the FDA was not intended for the general public and is here included out of necessity, thank you).
3. Media Release: Brisbane, Australia 4th April 2011
Merilyn Haines, the director of the newly formed group FAN-Australia (Fluoride Action Network Australia), has found some startling statistics buried deep in official research material by ARCPOH (The Australian Research Centre Population Oral Health at the Adelaide Dental School) that could scuttle the water fluoridation program once and for all.
Haines has found in the ARCPOH statistics that the permanent teeth of children in largely unfluoridated (<5% before 2009) Queensland were erupting on average two years earlier than the children in the rest of Australia, which is largely fluoridated (see the figure below). A two-year delay would negate all the small reductions in tooth decay claimed by dental researchers since 1990. In other words fluoridation doesn’t work. Any difference in tooth decay claimed to be due to fluoride is simply an artifact of the delayed eruption caused by fluoride.
Source – Published and unpublished data from 2003- 2004 Australian Child Dental Health Surveys
(unpublished data obtained by Freedom of Information application)
According to Professor Paul Connett, director of the Fluoride Action Network, who is currently on a fluoride-tour of New Zealand, “Critics of fluoridation, like Dr. Hardy Limeback in Toronto, have long pointed out that any reduced tooth decay touted by promoters could easily be accounted for by the delayed eruption of the teeth. Even when this argument received strong experimental support from Komarek et al. in 2005, this has still has been ignored by those promoting fluoridation. But they cannot ignore it any longer: the figures of the dental department research team most associated with the promotion of fluoridation in Australia (and beyond) demonstrate that this delay is real.”
Less teeth erupted for any given age would mean less surfaces available for tooth decay to have taken place. A delayed eruption of one – two years would account for the small reductions claimed in ALL the US and Australian studies published since 1990 (Brunelle and Carlos, 1990; Slade et al., 1996; Spencer et al., 1996; Armfield et al., 2009; Armfield, 2010). These studies have found reductions ranging from 0.12 of one permanent tooth surfaces saved in Western Australia (Spencer et al., 1996) to 0.6 permanent tooth surface saved in the largest survey ever conducted in the US (Brunelle and Carlos, 1990). This is not very much when you consider that there are five surfaces to the chewing teeth and four to the cutting teeth, and by the time all the child’s teeth have erupted there are a total of 128 tooth surfaces. One tooth surface saved amounts to less than 1% of all the surfaces in a child’s mouth. Now even this small benefit has evaporated.
More on the history.
In 1999, the National Health and Medical Research Council, Australia’s peak Medical Research body, stated that, “evidence exists that tooth eruption is delayed in fluoridated areas. It has been suggested that a proper comparison of caries rates should involve children one year older in fluoridated areas than in non- fluoridated areas.”
In 2000, the York Review pointed out that none of the studies that they had reviewed had controlled for “the number of erupted teeth per child” (McDonagh et al., 2000, p.24).
In 2005, Komarek et al. did control for eruption of teeth and reported no difference in decay between children living in Belgium receiving fluoride supplements (and those who weren’t) that was relatable to fluoride exposure (as measured by the severity of dental fluorosis).
In 2009, Peiris et al. reported that children in largely fluoridated Australia had a delay in “dental age” of 0.82 years compared to children in largely unfluoridated UK. However, the authors did not discuss the possible reasons for this delay and the number of children involved in the study (about 80 in each country) was not very large.
2011. Now the bombshell – the delay has been found and it is in the official statistics. ARCPOH has failed to respond to several inquiries on this matter. According to Haines, “Surely, this must end water fluoridation. If it doesn’t work what’s the point of putting this toxic substance into the drinking water and what reason can they possibly have for forcing it on people who don’t want it?”
However, this isn’t just about teeth. The finding could be even more significant than that. If fluoride causes a delayed eruption of the teeth then the most likely mechanism for doing so is fluoride’s ability to lower thyroid function (see chapter 8 in the 2006 National Research Council review, “Fluoride in Drinking Water.” According to Connett, “Lowered thyroid function in infants would mean slower growth of their tissues and could explain the 24 studies that have found an association between lowered IQ in children and exposure to moderate levels of fluoride in China, India, Iran and Mexico.”
It also raises the possibility that millions of people in fluoridated countries suffering from hypothyroidism have had this condition caused, or exacerbated, by exposure to fluoridated water. Haines’ asks “If ingesting fluoride delays tooth eruption for 1 to 2 years what other effects is it having on our bodies?”
Meanwhile, if swallowing fluoride does not reduce tooth decay, why would any reasonable person, decision maker or regulatory official continue to sanction adding fluoride to the public water supply?
Australian media contacts mobiles - 0418 777 112 and 0403029077
Media Release sent by Queenslanders For Safe Water on behalf of Fluoride Action Network Australia Inc
The Water Safety Additives Act was proposed by Port Angeles citizens.
