FDA’s Contradictory Explanations
As documented elsewhere in this section, the FDA has never approved prescription fluoride drugs (“supplements”) as safe or effective and has, in fact, rejected the fluoride drugs that it was asked to consider. When asked to explain why it continues to allow prescription fluoride supplements to remain on the market, the FDA has provided a series of contradictory explanations, including some that are demonstrably false.
The explanations that the FDA has provided include the following:
Explanation #1: Fluoride supplements were used prior to 1938:
One of FDA’s explanations for not approving fluoride supplements is that they “are identical to fluoride products marketed prior to 1938.” This is demonstrably incorrect.
In 1938, Congress passed the Food Drug and Cosmetic Act (FDCA), which required that drugs must be proven safe, as determined by the FDA, prior to entering the market. The law created an exception, however, for drugs that were already on the market. This “grandfather clause,” allowed pre-1938 drugs to remain on the market without a determination of safety. The FDA has cited this clause as the basis for not needing to approve fluoride supplements.
The problem with this explanation is that fluoride supplements were not on the market prior to 1938. As Merck Indexes from the 1930s demonstrate, there was not a single fluoride product meant for human ingestion as a tooth decay preventative. In fact, prior to 1938, fluoride’s primary use was as a rodenticide (a chemical that kills rodents), while in Europe, some doctors were using it as a drug to reduce thyroid activity.
Despite these facts the FDA has claimed the following:
“The fluoride tablet and drop drug products you identified in your fax are not subject to the new drug requirements since they are identical to fluoride drug products marketed prior to 1938. Therefore, the FDA has not reviewed any new drug applications for the fluoride tablets or drops. Drug products marketed now that are identical to drug products marketed prior to the new drug requirements of 1938 and 1962 are presently allowed to be marketed without new drug applications.”
SOURCE: Sakineh Walther, Food & Drug Administration, August 21, 2000. [See document]
“Sodium fluoride has been marketed in the United States since before 1938, when the Food, Drug, and Cosmetic Act (the Act) was enacted… Drugs on the market prior to enactment of the 1938 law were exempted, or “grandfathered”, and manufacturers were not required to file an NDA. The premise was that all pre-1938 drugs were considered safe, and if the manufacturer did not change the product formulation or indication, then an NDA was not required. However, once a manufacturer made any change to a pre-1938 drug, that drug was considered by the FDA to be a ‘new drug’ and the manufacturer was required to prove that the drug was safe for its intended use.”
SOURCE: FDA Center for Drug Evaluation and Research, March 9, 2004. [See email]
Explanation #2: fluoride supplements were used prior to 1962:
FDA has also justified its inaction by claiming that fluoride supplements were on the market prior to 1962 and are subject to FDA’s ongoing “DESI Review.” Again, however, this claim does not withstand scrutiny. While it is true that fluoride supplements were on the market prior to 1962, they do not come within the purview of the DESI review process.
In 1962, Congress amended the FDCA to require that all drugs be effective in addition to safe. As with the 1938 law, Congress created a grandfather clause for drugs that were already on the market prior to 1962. These drugs were allowed to remain on the market pending further review (known as a “DESI Review”). However, the DESI Review only applies to pre-1962 drugs that the FDA had already approved as being safe. The FDA made no such determination with fluoride. As noted by John Kelly:
“The FDA had made it clear to my office over the years that these fluoride products are not part of the DESI review. The DESI review concerns about products which were approved by the FDA after the manufacturer submitted an NDA demonstrating safety. These DESI products were approved between 1938 and 1962.”
Despite these facts, the FDA has made the following statements:
“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. Drugs in use prior to 1962 are being reviewed under a proess known as the drug efficacy study implementation (DESI). The DESI review of fluoride-containing products has not been completed.”
SOURCE: Melinda Plaisier, Food & Drug Administration, December 21, 2000. [See document]
“The FDA is aware of sodium fluoride-containing products in various dosage forms that are currently marketed. At the present time, the FDA is deferring any regulatory action on sodium fluoride products that were marketed prior to 1962 as long as the currently marketed product is identical to the pre-1962 product. Any prescription sodium fluoride-containing product coming into the marketplace after 1962 that is not identical to the pre-1962 labeling and that has drug claims, is subject to the FDA drug review process prior to marketing.”
SOURCE: FDA Center for Drug Evaluation and Research, March 9, 2004. [See email]
Explanation #3: Following the recommendations of a 1975 FDA Dental Committee:
A third explanation offered by FDA is that it is acting in accord with an unpublished proposal from an FDA Dental Committee in 1975. According to a summary provided by the FDA, the 1975 committee (comprised of ardent pro-fluoridation dentists) recommended that the FDA approve fluoride supplements as “safe and effective.”
There are several serious problems with FDA relying on the 1975 panel’s opinion. First and foremost, it was never published or acted upon by the FDA, and thus cannot substitute for an actual safety and effectiveness determination as is required by the FDCA. While the FDA acknowledges this fact, it nevertheless uses the panel’s assessment as a “policy” that justifies its failure to act in accord with the FDCA’s requirements.
Moreover, it bears noting that the FDA convened a second panel on fluoride supplementation in the 1970s that reached conclusions at odds with the 1975 panel’s glowing assessment. The second panel concluded that fluoride supplements “were not justified” as an over-the-counter product “since the small amounts needed for fluoride balance are easily provided in the diet.” While the second panel dealt with over-the-counter fluoride supplements, its conclusion — which the FDA published — is highly relevant to an assessment on the effectiveness of fluoride supplementation (especially considering the increase in fluoride from other sources that has continued to occur since the 1970s as evident by the increased rates of dental fluorosis in non-fluoridated populations.)
Despite these facts, the FDA now only references the unpublished opinion of the pro-fluoridation panel from 1975 to support its current “policy” on fluoride. To quote:
“There are no NDAs on file with FDA covering fluoride supplements for infants. However, at a meeting of The FDA’s Dental Drug Product Advisory Committee on January 22, 1975 it was unanimously decided to publish in the Federal Register (FR) the conditions under which dietary supplements of sodium fluoride or acidulated phosphate fluoride would be considered safe and effective. These conditions are described in Appendix I of the January 22, 1975 meeting minutes. Even though an FR was not published, as a matter of policy, the FDA has used, in part, the committee’s recommendations to evaluate these kind of products.”
SOURCE: Frank Fazzari, Food & Drug Administration, January 28, 1993. [See document]
“With regard to the regulatory basis for the marketing of fluoride supplements, FDA’s Dental Drug Products Advisory Committee evaluated these vitamin/fluoride supplements in January 1975. The Committee concluded that the regular use of vitamin/fluoride supplements will reduce the incidence of dental caries. As a matter of policy, the FDA has used, in part, the committee’s recommendations to evaluate such products. Accordingly, if these products are marketed pursuant to the conditions described in Appendix I, and also meet the conditions described in the Compliance Policy Guide 7132c.02… the FDA does not currently object to the marketing of these products.”
SOURCE: Diane Thompson, Food & Drug Administration, June 14, 1995. [See letter]
EXPLANATION #4: FLUORIDE IS A “DIETARY MINERAL SUPPLEMENT”
In 2005, the FDA added yet another explanation for its failure to regulate fluoride. This time, FDA claimed that it did not need to approve fluoride supplements because fluoride is a “dietary mineral supplement” protected by the 1976 Proxmire Amendment.
The problem with this explanation is that the FDA has repeatedly stated that fluoride is not a nutrient, but a drug, when used for therapeutic effect. Indeed, in 2000, FDA was specifically asked by Congress whether it considers fluoride to be a drug when used to prevent tooth decay. In response, the FDA stated:
“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.”
Despite this fact, the FDA has stated the following:
“The 1976 Proxmire Amendment (section 41 of the Federal Food, Drug, and Cosmetic Act) prohibits FDA from setting maximum limits on the potency of vitamins and minerals sold as dietary supplements and from classifying them as drugs solely because of high potency… Acccordingly, a dietary supplement containing fluoride is lawful for sale in the United States…”
SOURCE: Robert Moore, Food & Drug Administration, November 17, 2005. [See document]