FDA removing from market concentrated ingestible fluoride prescription drug products for children

The Food and Drug Administration is removing from the market concentrated ingestible fluoride prescription drug products for children.

The FDA noted in a May 13 announcement that these drugs are swallowed and ingested by infants and toddlers and have never been approved by the agency.

"Ingested fluoride has been shown to alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in childhood," according to the FDA. "Other studies have suggested an association between fluoride and thyroid disorders, weight gain and possibly decreased IQ."

The FDA set an Oct. 31 deadline for completing a safety review, a public comment period, and for taking appropriate action regarding removal of these products from the market. The Department of Health and Human Services will release best practices for child dental hygiene that do not alter gut health and are feasible and effective.

"The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” FDA Commissioner Marty Makary said in a statement.

The announcement follows Health and Human Services Secretary Robert F. Kennedy, Jr., announcing last month that he plans to tell the Centers for Disease Control and Prevention to stop recommending fluoride in drinking water.