ADA defends safety and efficacy of fluoride supplements amid FDA review

ADA leaders are emphasizing the evidence-based effectiveness and safety of fluoride supplements in comments submitted July 11 to the U.S. Food and Drug Administration.  

This comes after the FDA’s request for input on the use of orally ingestible unapproved prescription drug products containing fluoride in the pediatric population, as outlined in a June Federal Register notice. It also follows an FDA news release announcing a scientific review of the safety of prescription-strength fluoride supplements.

In its six-part submission, the ADA said the majority of peer-reviewed, widely accepted scientific evidence does not support the idea that fluoride ingestion at recommended levels is harmful. The documentation includes reviews of fluoride’s effectiveness in preventing tooth decay; current prescribing practices; and analyses of claims regarding its impact on neurological development, gut health and thyroid function. 

“You will find that the plurality of generally accepted scientific evidence does not support the hypothesis that fluoride ingestion is harmful, certainly not at recommended levels of exposure,” ADA President Brett Kessler, D.D.S., and Interim Executive Director Elizabeth Shapiro, D.D.S., J.D., said in the comments.  

The ADA emphasized that fluoride-containing products — ranging from community water fluoridation to toothpaste, rinses and supplements — function collectively to reduce cavities and improve oral health.  

Additionally, the Association referenced its newly updated educational resource, “Fluoridation Facts,” as a tool for addressing widespread myths and misperceptions. The document outlines the safety, efficacy and cost-effectiveness of various fluoride applications. 

“We would welcome the opportunity to explore how the ADA can partner with FDA on a review of prescription-strength fluoride supplements,” Drs. Kessler and Shapiro wrote. “In the meantime, we urge you to prioritize high-quality studies that are consistent with the review standards of the National Academies of Science, Engineering and Medicine, and other reputable scientific organizations — and discount literature that does not meet that standard.” 

The ADA also sent out an Action Alert urging members to register a comment in support of fluoride supplements, which can be done here by July 16. 

"We urge you to act swiftly and encourage your colleagues, staff, and patients to take action, too. This is a critical opportunity for the dental profession to be heard before access to a valuable caries-prevention tool is lost," the alert said.