Fluoride Action Network

FDA/Fluoride Files

The documents that show (1) the Food & Drug Administration (FDA) has never approved fluoride supplementation as a safe and effective treatment despite 50+ years of prescriptions, and (2) FDA's explanations for this situation do not withstand scrutiny.


UPDATE (May 2016): FAN has filed a Citizen Petition to FDA calling on the Agency to remove all fluoride supplements from the market. Read the Petition here, and show your support by signing this online letter to FDA!

Fluoride supplements were designed to provide children living in non-fluoridated areas the daily equivalent of drinking an average amount of fluoridated water (up to 1 mg/day). For over 50 years, millions of children have been prescribed fluoride supplements by their dentist or pediatrician. As the documents in this section demonstrate, the FDA has never approved any fluoride supplement as safe and effective. When the FDA has been asked, by Congress and others, to explain its regulatory treatment of fluoride, it has provided numerous contradictory explanations, some of which are demonstrably incorrect.

About the Documents

The documents in this section are mainly the result of a nine-year investigation by the late New Jersey Assemblyman, John Kelly. Kelly became interested in fluoride after a study from the New Jersey Department of Health found higher rates of osteosarcoma (bone cancer) in adolescent males drinking fluoridated water. In this detailed account of his experience trying to get studies demonstrating fluoride’s safety/effectiveness from the FDA and other government agencies:

“The FDA has been aware for at least the past 35 years that these unapproved products are being prescribed to millions of infants and children. They have been fully aware of the potential side effects of these products as listed in numerous publications, such as the NTP Toxicological Fluoride Profile, the Physicians Desk Reference, Clinical Toxicology of Commercial Products, and the Merck Index. The FDA has allowed these children to endure adverse health effects and has allowed their parents to be defrauded out of millions of dollars for products which the FDA does not recognize as either safe or effective. By ignoring the law for 35 years, the FDA has made it clear that their concern is the well being of industry, not the public.”

The Documents:

  • Is Fluoride a Drug, or a Nutrient?: In statements spanning from the 1960s to 2000, the FDA has repeatedly confirmed its position that fluoride is a drug, not a “nutrient,” when used to prevent disease.
  • Fluoride Supplements Have Never Been Approved: As these documents show, not only has the FDA never approved a fluoride supplement, it has rejected the only two for which it has made a final determination.
  • FDA’s Contradictory Explanations: An examination of FDA’s shifting explanations for its regulatory treatment of fluoride.
  • Letters from John Kelly: Kelly’s letters, to both the FDA and CDC, are a must read.
  • Miscellaneous Files: From as far back as the 1940s, when the FDA barred fluoride-adulterated from entering the market, to the 2000s when the FDA allowed bottled water companies to market fluoridated water as a method for preventing tooth decay. 
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