U.S. FDA to remove ingestible fluoride prescription drugs for children from market

The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed, Oct. 14, 2015. (AP Photo/Andrew Harnik, File)

The U.S. Food and Drug Administration said on Tuesday it will start removing prescription drug products for children that have concentrated ingestible fluoride from the market.

Ingestible fluoride drugs such as fluoride supplements have never been approved by the FDA, the agency said.

These supplements have been shown to alter the gut microbiome of children, a major concern given its early development in childhood, the FDA said.

The FDA has set a goal date of October 31 for completing a safety review and public comment period.

It also plans to take appropriate action regarding the removal of these products from the market by the end of October.

Fluoride, a mineral that occurs naturally in water, soil and air, has been demonstrated to prevent dental cavities or tooth decay. It works by strengthening the tooth’s enamel against the acid produced by bacteria that cause tooth decay.

According to the U.S. Centers for Disease Control and Prevention, fluoride supplements can be prescribed by a dentist or a pediatrician for children at high risk of cavities. These supplements are normally in the form of a tablet that is chewed.

“Ending the use of ingestible fluoride is long overdue,” Health Secretary Robert F. Kennedy Jr said.

Kennedy had previously called for removing fluoride from public water, in the absence of conclusive evidence that the permitted water fluoridation levels in the U.S. are associated with numerous health issues including cancer.

The U.S. Department of Health and Human Services also plans to circulate best practices for dental hygiene in children that are “feasible, effective and do not alter gut health.”

(Reporting by Sriparna Roy and Sneha S K in Bengaluru; Editing by Shreya Biswas)