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.

Nutrient or Drug?

The term “fluoride supplement” is a misnomer as it implies that the product is a dietary supplement, like calcium and other nutrients. Fluoride, however, is not a nutrient. A nutrient is something the body has a physiological demand for–they’re not optional; we need them. As the FDA has long recognized, fluoride is not necessary to human health or development. When used to prevent disease, therefore, the FDA considers fluoride to be a drug.

The term “fluoride supplement” is also a misnomer because most dietary supplements can be purchased over the counter (i.e., without a prescription). Fluoride supplements, however, cannot be purchased over the counter; they are only available by prescription from either a licensed dentist or doctor.

FDA: Fluoride is a drug, not a nutrient:

“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.”
SOURCE: Food & Drug Administration, December 21, 2000. [See document]

“In summary, FDA does not list fluorine as an essential nutrient.”
SOURCE: Food & Drug Administration, October 1990. [See document]

“Your question: ‘The United States Food and Drug Administration says that sodium fluoride is necessary for health. Correct?’ The answer is ‘No.'”
SOURCE: Food & Drug Administration, March 17, 1967. [See document]

“Sodium fluoride used for therapeutic effect would be a drug, not a mineral nutrient. Fluoride has not been determined essential to human health. A minimum daily requirement for sodium fluoride has not been established.”
SOURCE: Food & Drug Administration, August 15, 1963. [See document]

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