Fluoride Action Network

FDA Responds to Assemblyman Kelly’s Petition to Remove Unapproved Fluoride Supplements

Fluoride Action Network | May 13, 2001

In 1938, the Food Drug and Cosmetic Act was passed into law. The law states that before any prescription drug can enter the market, it must be shown to be safe by the FDA (Food and Drug Administration). Later, in 1962, an amendment to the Food Drug and Cosmetic Act was passed, which stipulated that in addition to clinical evidence of safety, the FDA also has to obtain evidence of effectiveness before allowing a drug into the market. Fluoride supplements, however, which are currently being prescribed to millions of American children, have NEVER been approved by the FDA as either safe or effective.

According to New Jersey Assemblyman John Kelly, who has brought much of this information to light:

“I was stunned when I was advised by the FDA that fluoride supplements were not approved by the FDA. Incredibly, in fifty years, no one has ever bothered submitting a petition to the FDA to have these products approved!”

The FDA defends this strange omission, by mistakenly arguing that the agency doesn’t need to approve prescription fluoride supplements because they were being prescribed before 1938. (According to the Food Drug and Cosmetic Act, drugs prescribed before 1938 need not have clinical evidence of safety and effectiveness.)

According to the FDA:

“…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.”

However, Assemblyman Kelly has pointed out that fluoride supplements were NOT being prescribed before 1938. According to Kelly:

“Clinical trials of dietary fluoride supplements did not begin until the 1940’s.  The American Dental Association published its first recommendations for fluoride supplements in 1958.   The American Academy of Pediatrics followed with its own recommendations in 1972.   Clearly, these dosed prescription drugs for dental use are post-1938 products, thus requiring NDAs [New Drug Applications]”

Indeed, according to the 1940 Merck Index, the only medical uses of sodium fluoride at the time were external in application (e.g. as an antiperiodic and antiseptic) and had nothing to do with reducing tooth decay. And thus as Kelly has rightly pointed out, there is no way that current fluoride supplements are “identical” to drugs marketed before 1938. For before 1938, there were NO such fluoride supplements being prescribed.

In light of this glaring absence of responsibility from the FDA, Assemblyman Kelly petitioned the agency in October of 2000 to remove fluoride supplements from the market until evidence of safety and effectiveness is obtained. In his petition, Kelly stated:

“Parents are spending millions of dollars annually on products that have not been proven effective.  They then have to spend millions more to repair the fluorosis caused by these products.   Every health care dollar spent on ineffective drugs is one dollar less available for effective drugs”

Kelly added that:

“The manufacturers of fluoride supplements have had fifty years to conduct clinical trials and toxicology studies to demonstrate the safety and effectiveness of systemic fluoride and submit them for FDA approval.  They have not done so.  Fifty years is a long time – even for the FDA.”

In response to Kelly’s petition, which expired May 6, 2001, the FDA resorted to a different line of defense. No longer arguing that there were “identical” pre-1938 fluoride supplements, the FDA’s Janet Woodcock told Kelly that “the Food and Drug Administration has not yet resolved the issues raised in your citizen petition submitted on November 6, 2000.”

So here we are, the FDA is unable to resolve the issue. It admits that it has never approved fluoride supplements as safe or effective – a serious violation of the Food Drug and Cosmetic Act. And despite knowing this, the agency has failed to draw the obvious conclusion – that these unapproved drugs should not be allowed on the market.