The U.S. Food and Drug Administration (FDA) has moved to restrict the use of prescription ingestible fluoride supplements in children under the age of 3 or older children who are at a moderate or lower risk of tooth decay, according to a press release dated October 31 from the FDA.
The FDA sent letters to companies notifying them of its plans to take enforcement action against those marketing supplements, which are not approved by the agency, for use in children under age 3 or older children at low or moderate risk for tooth decay, according to the press release.
This move by the FDA is less strict than its original plan to ban fluoride supplements from the market.
“It’s scary that these products have been used for decades without approval,” U.S. Health and Human Services Secretary Robert F. Kennedy Jr. said in the press release. “Today’s action raises public awareness, informs medical professionals, and builds on President Trump’s commitment to Make Our Children Healthy Again.”
In July, the FDA held a hearing to collect feedback on the clinical use and safety concerns associated with prescription fluoride supplements for kids. The FDA claims these ingestible fluoride products, which often are given to children at high risk of tooth decay, may alter the gut microbiome and possibly are associated with weight gain, thyroid disorders, and a decrease in IQ.
During that hearing, Dr. George Tidmarsh, PhD, director of the U.S. Center for Drug Evaluation and Research, remarked that fluoride supporters’ presentations lacked the robust scientific data that opponents provided. Also, Tidmarsh didn’t seem sold on the benefits, noting that supplements have never undergone the full FDA process of determining whether the benefits outweigh the risks.
The ADA issued a statement on October 31 stating that fluoride supplements are effective at reducing tooth decay and are one method for maintaining oral health when used at a proper dose daily.
“Prescription-strength fluoride supplements are safe, but they are not prescribed for everyone; their use should remain a thoughtful decision made between a dentist and the patient,” ADA President Dr. Richard Rosato said in the statement.
“Appropriate fluoride supplementation is based on each child's unique needs. Determining patients’ needs for a fluoride supplement must include individual discussions between parents and guardians with their children’s dentists and pediatricians” Rosato added.
