The U.S. FDA has announced new actions to limit the sale of unapproved ingestible fluoride prescription drugs intended for children. Four companies have been notified of potential enforcement for marketing oral fluoride products that have never been formally reviewed or approved for safety, effectiveness, or manufacturing quality despite their decades-long use since the 1940s.
While topical fluoride treatments remain proven for cavity prevention, the FDA highlighted possible health risks from swallowed fluoride, including effects on the gut microbiome and child development.
This initiative reflects the agency’s ongoing commitment to ensure pediatric medicines meet modern scientific and safety standards. The FDA is also developing a national oral health strategy and fluoride research agenda to close data gaps and strengthen future regulation.
You can read the full story on the FDA’s website:
