December 17, 2012Department of Health and Human Services Public Health Service U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Regulatory Policy Rockville, MD 20857
Dear FDA Project Reviewers,
This letter supports the petition to ban the infusion of industrial fluoride compounds into public water supplies, FDA2007-P-0346, formerly 2007P-0400.
Summarized in earlier letters, the FDA ruled from 1963 to 1993 that fluoride is not a mineral nutrient and addition of fluorides into water is an uncontrolled use of an unapproved drug, and that fluoride has never been approved by the FDA to be taken internally through ingestion, and in 1989 the FDA (see letter dated November 4, 2012) rejected approval based on controlled human clinical trials with sodium fluoride taken longterm conducted by the National Institutes of Health (Pollner, F., Medical World News, Nov. 13, 1989). (Bone mass increased abnormally in the fluoride treated cohort without effect on bone strength and more skeletal lesions were reported in the treated group with high incidence of painful lower extremity syndrome. The toxic effects of fluoridated bone may not be manifest for 30 or more years when the bone is unable to accommodate any further fluoride, at which point fluoride is stored in soft tissues).
This is to also inform and remind the current staff at the FDA that in 1966 the FDA officially banned the sale, by manufacturers, of fluoride compounds for oral administration to pregnant women to affect the developing fetus for dental caries. This was printed in the Federal Register (October 20,1966, ‘FDA statements of general policy or interpretation, oral prenatal drugs containing fluorides for human use). In the research article in Public Health Reports by Horowitz, H. and Heifitz, S. (April, 82:297-304, 1967), http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1919981/, the following quote was published:
The FDA, recognizing insufficient evidence existed to support claims of benefits from prenatal use of preparations containing fluoride, banned the marketing by manufacturers of these products offered for prenatal decay prevention.
Please understand that fluoride promoters make the routine first assumption that ‘fluoride is good’ (personal communication, Dr. Donald Lyman, CA Department of Public Health) and have thus become blinded in suggesting that fluoride in bone ‘must strengthen bone’ and in the pregnant mother acting on the fetus ‘must prevent caries’ in developing teeth after birth. Both of these extreme ideas had no data of support and have been overturned carefully by the U.S. FDA. As described in the Petition for Reconsideration submitted to the FDA, the EPA (in the 1979 Memorandum of Understanding with the FDA) was never given authority to regulate the use of unapproved drugs. EPA instead was given authority to regulate water additives, all designed to treat water to purify it. Agents used to treat people are regulated under the exclusive authority of the FDA, and indeed the FDA has thus far properly banned the sale of fluorides for ingestion by pregnant women in the U.S. Thank you.
Further, it has now been six months since asking the CDC to clarify why fluoride in saliva that bathes teeth topically (0.02 ppm) is 75,000 times less concentrated than in toothpaste (letter to FDA dated August 21, 2012). The CDC after two months responded that they have no answer to the inquiry and would send it to others to try to find an answer. No answer has been provided to date and I have been advised by legal counsel that it is therefore legal and proper to conclude that the CDC, in not providing a timely answer, does not have an answer and cannot continue to claim authority to promote or authorize the infusion of industrial fluoride compounds into public water supplies. The FDA is hence asked on behalf of the citizens of these United States to ban the practice of adding industrial fluorides into public water supplies to treat people for dental caries, when it has not been FDA approved for this purpose.
Thank you for your attention,
Richard Sauerheber, Ph.D.