Fluoride Action Network

Petition Asks FDA to Remove All Unapproved Fluoride Supplements from Market

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Fluoride Action Network | Press Release | May 18, 2016

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Petition Asks FDA to Remove All Unapproved Fluoride Supplements from Market

LOS ANGELES, CA – The U.S. Food & Drug Administration (FDA) has issued a “Warning Letter” that orders a manufacturer of fluoride drops and tablets to “immediately” discontinue marketing these products because FDA has never approved them as safe and effective. Now the Fluoride Action Network (FAN) has joined with The International Academy of Oral Medicine & Toxicology (IAOMT) to petition the FDA to take similar action against all other companies producing unapproved fluoride drugs, commonly known as fluoride “supplements.”

Fluoride supplements are sodium fluoride-containing drops, tablets, and lozenges sold for the purpose of preventing tooth decay. Despite being labeled “supplements,” the FDA’s Warning Letter states that these products are “drugs” which are “not generally recognized as safe and effective” for cavity prevention.

Although prescribed to millions of children for decades, no manufacturer has ever submitted clinical evidence to the FDA to prove the safety and effectiveness of fluoride supplements. As FDA’s Warning Letter confirms, the agency considers fluoride supplements “unapproved new drugs” that are unlawful to sell.

The FDA issued the Warning Letter in January to Kirkman Industries, Inc., one of the manufacturers of fluoride supplements.

“Each and every one of the issues that FDA identified with Kirkman’s fluoride supplements is equally applicable to the fluoride supplements being manufactured by other companies,” states attorney and FAN Executive Director, Michael Connett.

A number of pharmaceutical companies, including Libertas Pharma, Sancilio & Company, Inc., and Qualitest, continue to manufacture fluoride supplements, and the nation’s largest pharmacies continue to sell them, including Walgreens, CVS, Rite Aid, and Walmart. “This ongoing, widespread sale of unapproved fluoride drugs constitutes a systematic violation of federal and state law,” Connett states.

Fluoride supplements were launched in the 1940s on the now universally discredited premise that fluoride needs to be ingested during early childhood to provide a meaningful role in cavity prevention. The overwhelming body of evidence today shows that fluoride’s predominant effect on cavities comes from topical application, not ingestion.

“There is no need for children to be swallowing any fluoride, whether in drops, tablets, or any other form, including water,” notes Connett.

Recent scientific and medical research shows that ingesting fluoride poses serious health risks. In 2006, the National Research Council identified fluoride as an “endocrine disruptor” that can impair the normal functioning of the thyroid gland, and in 2014, The Lancet published a paper classifying fluoride as one of 11 chemicals known to damage the developing human brain (i.e., a “developmental neurotoxin”), alongside lead and mercury.

“Whether fluoride is added to water or prescribed as a supplement, it is a neurotoxic and endocrine disrupting substance with no discernible health benefit when swallowed,” comments Dr. Jack Kall, DMD, Chairman of IAOMT’s Board Directors. “We are seriously concerned that there have been no safety studies done on fluoride supplementation and no accurate assessment of just how much fluoride Americans are taking into their bodies from water, supplements, and an array of other sources.”

“Rather than continuing to increase children’s ingestion of fluoride, the urgent need now is to find ways to reduce it,” adds Connett. “Removing unapproved fluoride drugs from the market is one important and obvious way to do so.”

The formal petition filed by FAN and the IAOMT can be viewed in its entirety at http://fluoridealert.org/citizen_petition/.

Public support for the petition has been significant, with over 8,000 signatures achieved in the first 48 hours since the petition went public. All signatures supporting the petition (via http://fluoridealert.org/fda/) will be uploaded to FDA’s website before the comment deadline and addressed to Robert M. Califf, M.D., Commissioner, U.S. Food and Drug Administration, and Secretary Sylvia Mathews Burwell, of the U.S. Department of Health and Human Services.