The American Dental Association and the CareQuest Institute for Oral Health have spoken out against the FDA’s decision to limit the use of ingestible fluoride products.
The HHS Department said in May 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. Instead, the FDA moved to restrict its use last month.
The FDA announced Oct. 31 that it sent letters to four companies notifying them of its intent to take enforcement action against those marketing unapproved fluoride drug products. It also sent letters to healthcare professionals warning about the risks associated with products.
The enforcement applies to fluoride-containing ingestible drug products labeled for use in children under three years of age, or with labeling that does not limit use to children at high risk for dental caries.
In May, the ADA and the American Dental Hygienists’ Association spoke out against the proposed ban, citing a lack of evidence for the HHS Department’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.
The ADA said Oct. 31 that the decision to prescribe fluoride supplements should be made based on individual discussions between doctors and their patients. The organization also reiterated its guidance for the use of these products for patients in specific age groups.
“The research shows that daily use of fluoride tablets or drops at home are a safe and effective way to strengthen teeth and prevent cavities in children who are at high risk for tooth decay and whose water is deficient in fluoride,” ADA President Richard Rosato, DMD, said. “A doctor’s clinical judgment, not a new warning label, should remain the guiding factor in determining appropriate fluoride use for children, ensuring both safety and access to essential oral health care.”
The CareQuest Institute for Oral Health said that although the FDA’s limitations are not as restrictive as a full ban, it is still concerned when efforts to scale back water fluoridation in several states are taken into consideration.
“Decades of research show that fluoride — when used appropriately — is a safe and effective tool for preventing tooth decay and strengthening developing teeth,” Melissa Burroughs, CareQuest’s senior director of policy and advocacy, said Nov 4. “This conflicts with decades of guidance from pediatric and dental experts and risks deepening a growing oral health crisis for children.”
