FDA to pull prescription fluoride supplements from market

Safety review, public comment period to conclude in October

The U.S. Food and Drug Administration announced May 13 that it plans to remove prescription fluoride supplements from the market once a safety review is completed. The ADA is affirming its support of fluoride supplements, which it said have proven to be effective at reducing tooth decay. 

The FDA’s safety review applies to ingestible fluoride prescription drug products for children. It does not include toothpaste, mouth rinses or topical products containing fluoride. In a news release following the announcement, the Association highlighted the fact that in many nonfluoridated communities and rural areas, fluoride supplements are the only chance for many to receive the appropriate amount of fluoride to prevent tooth decay.  

“Proposals like this stand to hurt rural America, not make them healthier. More than ever, at this critical time in American health care policy, it is vital that we slow down to properly study the full implications of actions like this on the health of the nation,” ADA President Brett Kessler, D.D.S., said. 

The FDA said in its release that ingested fluoride has been shown to alter the gut microbiome, “which is of magnified concern given the early development of the gut microbiome in childhood.” However, the ADA said there is limited research on the studies of microbiome composition and fluoride association.  

The two literature reviews the FDA does cite note a positive effect on the oral microbiome and both find that the effect on the gut microbiome may be positive as well at low doses, according to the ADA. Likewise, the review on fluoridated water and thyroid function showed no changes at low levels of fluoride as found in the U.S., and potentially positive association with goiter and hypothyroidism in both children and adults.

The Association emphasized that the recommended fluoride intake of 0.7 mg/L will likely not be met if fluoride supplements or tablets are banned because few over-the-counter dietary supplements contain fluoride, and many multivitamins only contain trace minerals.

“While community water fluoridation is the most efficient method to [prevent cavities], the substitution of alternative decay prevention like fluoride tablets or supplements are recommended to glean the proven systemic benefits fluoride provides,” the ADA said.  

For more information, visit ADA.org/Fluoride.