Sauerheber – Letter 36 to FDA

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Richard Sauerheber, Ph.D.
(B.A. Biology, Ph.D. Chemistry, University of California, San Diego)
Palomar College, San Marcos, CA
Email: rsauerheber@palomar.edu
Phone: 760-744-2547 (home) 760-744-1150 xt 2448 (work)
May 12, 2013

U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Rockville, MD 20857

Dear Reviewers,

This note supports the petition to ban the addition of industrial, unnatural fluoride compounds into U.S. public drinking water supplies, petition FDA2007-P-0346.

Journal of Environmental and Public Health finalized publication. I am pleased at last to enclose the final research article accepted for publication in the Journal of Environmental and Public Health. The article took 19 years to complete and bears little resemblance to earlier versions submitted to the FDA. It is published in an open access journal and will be available free of charge online at the Journal website. This feature was paid for from public donations in support of the specific content of the article. The main findings are that calcium fluoride found as a natural contaminant in some waters is poorly absorbed and is impossible to cause acute poisoning, while industrial synthetic unnatural fluorides infused into water supplies as presumed dental prophylactics all lack calcium and are toxic calcium chelators that are fully assimilated. During accidental overfeeds treated water can and has caused acute lethal poisonings that are impossible with natural calcium fluoride due to solubility constraints.

Chronic effects are now extant from consumption of industrial fluoride in treated water, particularly in bone, while being unable to influence teeth caries through ingestion. As noted in the article, dentists introducing the Public Health Service to the idea of “fluoridation of water” based on natural calcium fluoride (which is the basis for historical support by former U.S. Surgeons General) later denounced the infusions of industrial fluoride into water. It was found that long-term ingestion cause fluoride incorporation into dentin and crumbly teeth interiors. The FDA in 1994 approved fluoride varnishes for topical use but has never approved ingestible fluorides that have the purpose of intentionally introducing the fluoride ion into the bloodstream. Fluoridation has caused directly visible unsightly teeth enamel permanent abnormal hypoplasia (dental fluorosis) in a wide swath of the U.S. population (see article).

Ingested fluoride ion does not decrease caries incidence. The landmark publication that demolished the idea that ingested fluoride ion decreases dental caries is the textbook by Dr. P.R. Sutton (Philip R.N. Sutton, The Greatest Fraud Fluoridation, Karunda Pty. Ltd., Lorne, Australia, 1996). The textbook provides exhaustive details from this academic statistician indicating the gross flaws in all the experiments intended to demonstrate that fluoridation of water supplies could decrease decay. The 334 page textbook has been reviewed and is strongly recommended reading for the FDA. Critics who promote fluoride ingestion submitted rebuttal materials that are included in the book. Detailed answers to those critical comments are also included that were never addressed by promoters of industrial fluoride ingestion. For example the famous fluoridated test city of Newburgh, NY has 5 times higher calcium concentration in drinking water than Kingston used as a control (page 178 enclosed). This helped minimize adverse health effects where bone cortical defects and delayed eruption of teeth occurred in the treated population. And since calcium helps build strong teeth, the interpretation that fluoride affected teeth caries is absurd. A prime precisely worded conclusion is “in the face of these new findings, that fluoridation does not reduce the number of decayed teeth, to now continue to medicate whole populations with uncontrollable doses of this very toxic substance, against the wishes of many people, some of who are very sensitive to fluoride poisoning, and yet are forced to drink this chemically treated water, and all to no purpose, is the height of folly” (p. 276).

FDA 1975 fluoride ruling. Published in the U.S. Federal Register, the U.S. Food and Drug Administration officially in 1975 ruled that fluoride is not considered generally safe to be taken internally through ingestion and thus its addition into foods would be illegal (Sutton, p. 5 and p. 102). A copy of pages in this textbook that describe this are enclosed. Since fluoride is recognized by the FDA as not safe for ingestion, and the information from Sutton proves complete lack of effectiveness of ingested fluoride for its intended purpose in consumers, it is imperative that FDA ban the sale of industrial fluorides intended to be used as an oral ingested dental prophylactic in all Americans from treated public water supplies.

Fluoridation Policy. The reviewers of the Journal article specifically requested a full description to be made public of current fluoridation policy in the U.S. in the context of these findings. It will be necessary for FDA reviewers to examine this article entirely in full because the FDA has been involved in the use of fluorides as oral ingestibles either directly or through water “fluoridation” (e.g. the 1966 ban of fluoride sales for internal use by pregnant women; the allowance of fluoride tablets by prescription in regions where water is not fluoridated and levels are below 0.7 ppm; rulings that fluoride in bone does not strengthen bone and that addition of fluoride which is not a mineral nutrient into water is an uncontrolled use of an unapproved drug, etc.).

U.S. Senators (personal communication from the office of CA Senator Feinstein) are regularly told by influential lobbyists that $38 are saved on dental care for every $1 spent on water “water fluoridation”. This is based on the assumption that ingested fluoride from water actually lowers caries incidence, which it unfortunately cannot. Caries reductions are due to factors such as brushing after eating sugary foods, not from swallowed fluoride in saliva at 0.02 ppm or in blood (see article). There are no “savings” from “fluoridation of water” when there are no reduction in caries from it.

Rationale for FDA ban. When the FDA does ban all infusions of industrial synthetic unnatural fluoride compounds into public water supplies for purported use as a dental prophylactic, then the public will need to be informed why this is now necessary. Reasons include but are not limited to:

1. Synthetic industrial fluorides lacking calcium are not natural and are fully assimilated and thus not directly comparable to natural calcium fluoride that can be found in some water supplies.

2. Artificially fluoridated water has been found in well-controlled research animal studies to be unable to influence teeth caries. In humans, the concentration of fluoride in saliva from drinking treated water has been found to be only 0.02 ppm which cannot exert an effective surface action on dental enamel. The blood concentration is rising above 0.21 ppm because total fluoride exposure has risen considerably in recent years from increasingly varied ingestible sources of fluoride.

3. Addition of industrial fluorides into water supplies that lack sufficient calcium causes full assimilation of the ion with undesired levels of bone loading after lifelong consumption from water in addition to that from other sources. Fortunately no cities in the U.S. have yet to be exposed to artificially fluoridated water for an entire human average lifespan – – the longest treated city has now been 68 years.

4. Efficient methods of caries prevention are now understood, namely ensuring first and foremost that sufficient calcium phosphate minerals are present in the diet to build healthy enamel during teeth development and to foster proper enamel remineralization in adult teeth.

5. Since unnatural fluorides are being used as ingestible dental prophylactics, any regulations are outside the jurisdiction of either the U.S. EPA or the U.S. CDC. Former recommendations from these agencies were developed based on natural calcium fluoride found in some water supplies that do not apply to artificial fluoridation.
We citizens view the ban as important and immediately necessary, particularly in view of the fact that fluoride promoters do not understand recent data and yet are forcing additional cities to infuse industrial silicofluoride compounds lacking calcium into water supplies. An egregious case is now ongoing in Portland, Oregon where the population is being forced to fluoridate water that is devoid of sufficient endogenous calcium and the action is widely opposed by the citizens themselves.

This is in the 7th year of supplying information to the FDA on this issue since the original ban petition was filed. We would appreciate from the FDA an approximate expected date at which time the FDA will be able to act on this petition.

We thank you very much for your attention,

Richard Sauerheber, Ph.D. Chemistry

Enclosures:
pages 5, 102, and 178 from Sutton, P. (1996) The Greatest Fraud Fluoridation.
Sauerheber, R. Physiologic Conditions Affect the Toxicity of Ingested Industrial Fluoride, Journal of Environmental and Public Health, May, 2013.

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