Fluoride Action Network

Petition Calls on FDA to Pull All Fluoride Supplements From the Market

Source: RAPS.org (Regulatory Affairs Professional Society) | May 18th, 2016 | By Zachary Brennan
Industry type: Pharmaceuticals

The Fluoride Action Network (FAN) and the International Academy of Oral Medicine & Toxicology (IAOMT) are calling on the US Food & Drug Administration (FDA) to expedite the removal from the market all unapproved, unsafe, unnecessary and ineffective sodium fluoride-containing drops, tablets and lozenges sold for the intended purpose of preventing tooth decay.

The petition, submitted to FDA on Monday, follows the agency’s issuance of a warning letter in January to Kirkman Laboratories, one of the manufacturers of fluoride supplements, to “immediately” discontinue marketing these products because FDA has never approved them as safe and effective.

FDA “should not limit its enforcement action against fluoride supplements to only Kirkman, as there are other, larger companies (e.g., Libertas Pharma, Inc.; Sancilo & Company, Inc.; and Qualitest) that are manufacturing and distributing identical fluoride supplements, which are being sold throughout the country by the nation’s four largest pharmacies (Walgreens, CVS, Rite Aid, and Walmart),” according to the petition.

According to the American Dental Association, dietary fluoride supplements, which it says are available only by prescription, “are recommended only for children living in non-fluoridated areas and at high risk of developing tooth decay.”

Fluoride supplements were first launched in the 1940s on the “universally discredited premise,” according to the petition, 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,” FAN and IAOMT said. “Further, the decades-old studies purporting to demonstrate benefits from fluoride supplements have been universally critiqued for their low quality, highly biased study designs. Today, leading experts in the fields of dental research and health care interventions, including the prestigious Cochrane Collaboration, have concluded that fluoride supplements are neither necessary nor effective, particularly in the current context of widespread exposures to fluoride toothpaste and topical fluorides. In short, fluoride supplements have become a useless relic of a discredited paradigm.”

The petition also includes conversations between the volunteers from FAN and IAOMT and pharmacists at CVS, Rite Aide, Walmart and Walgreens across the country, in which the pharmacists insist that because the supplements are prescription-only, they are approved by FDA.

“Each of the four pharmacies consistently assured the prospective customers that fluoride supplements are FDA approved or, alternatively, that FDA approval of fluoride supplements is not necessary,” the petition says.

FDA in 1995 issued an OTC monograph for fluoride, though as the petition notes, “each and every one of the products that FDA approved (i.e., toothpastes, rinses, and gels) are specifically designed to be topically applied to the teeth. Further, although the FDA approved a ‘fluoride supplement’ in the monograph, FDA made it expressly clear that a fluoride supplement must be in the form of a ‘rinse,’ and cannot be given to children under the age of 3. The sale of fluoride supplements in drop, tablet, and lozenge form, therefore, directly violates the framework that FDA enacted in its OTC Monograph, especially when prescribed to children under the age of 3,” the petition contends.

FDA petition