The FDA has begun to restrict the sale of ingestible fluoride prescription drug products for children.
Nine notes:
1. The FDA sent letters to four companies notifying them of its intent to take enforcement action against those marketing unapproved fluoride drug products.
2. The enforcement applies to fluoride-containing ingestible drug products labeled for use in children under three years of age, or with labeling does not limit use to children at high risk for dental caries.
3. The FDA also sent a letter to healthcare professionals warning about the risks associated with these ingestible fluoride products, according to an Oct. 31 news release.
4. The move is part of the White House’s Make America Health Again initiative, which directed the FDA to reevaluate fluoride products.
5. The HHS Department announced May 13 that the FDA would begin removing ingestible fluoride prescription drug products for children, claiming these products were never approved and that ingested fluoride has been shown to alter the gut microbiome. It also stated that ingested fluoride is linked to thyroid disorders, weight gain and possibly decreased IQ.
6. The agency engaged with members of the public and clinicians during its public comment period to gain additional information about fluoride products.
7. In May, the American Dental Association and the American Dental Hygienists’ Association spoke out against the ban, citing a lack of evidence for the agency’s claims and noting that these products are the only method for people living in non-fluoridated communities and rural areas to receive the appropriate amount of fluoride.
8. The FDA also published a scientific evaluation of ingestible fluoride products and their potential benefits and risks Oct. 31.
9. The HHS Department said it will work with the FDA and the National Institutes of Health to develop a fluoride research agenda and a national oral health strategy.
