An ingestible fluoride prescription drug product for children was pulled from the market on Tuesday after the Food and Drug Administration (FDA) said it was never approved.
The products are known as fluoride tablets, according to NPR. These include drops or lozenges meant for children who don’t get fluoridated water to help prevent cavities.
While toothpaste with fluoride or fluoride rinses are meant to be spat out, the tablets, are meant to be swallowed and ingested by toddlers and infant’s, according to an FDA statement.
Although FDA’s announcement claims that ingested fluoride alters the gut microbiome, causes thyroid disorders, causes weight gain and decreases IQ levels, the research it cites is inconclusive, according to The American Dental Hygientists’ Association’s (ADA) President Erin Haley-Hitz, who wrote in a press release that fluoride provided to children should be administered at scientifically safe levels.
“There is no scientific evidence that fluoride at low levels affects gut microbiota,” she wrote.
The ADA president added the FDA’s action comes at a “critical time” when states like Utah are eliminating community water fluoridation, creating unexpected challenges for oral disease prevention especially in rural areas and underserved populations with limited access dental care.
“While avoiding sugar and maintaining good oral hygiene are fundamental to dental health, these measures alone are insufficient,” Haley-Hitz wrote. “Fluoride and regular dental hygiene visits remain essential components of comprehensive cavity prevention, especially for those who lack resources for routine dental care.”
By Oct. 31, the agency hopes to complete a safety review and train individuals on the best practices for children’s dental hygiene “that are feasible, effective and do not alter gut health.”
The ADA said these interventions which include thorough risk assessments, targeted topical fluoride applications, silver diamine fluoride treatments and enhanced patient education require regular access to dental professionals which remains “a significant challenge in underserved areas.”
“We urge policymakers to consider the profound impact these decisions have on the oral health of the American people, and particularly vulnerable populations,” Haley-Hitz said in the statement. “And to support increased access to preventive dental care services.”
Original article online at: https://www.masslive.com/news/2025/05/never-approved-childrens-fluoride-recalled-by-fda-but-dentists-push-back.html