The Food and Drug Administration (FDA) warned companies selling prescription drugs containing fluoride for children on Oct. 31 that it intends to crack down on unapproved products containing fluoride.
“We are providing this notice to allow your company time to assess your products and take appropriate corrective actions,” regulators said in a notice to the companies.
An FDA analysis of ingestible fluoride products, which have been used since the 1940s but were never reviewed or approved, also released on Friday, said the products appear to reduce tooth decay in permanent teeth, but not in the teeth of younger children.
There are also risks to taking fluoride products, including tooth discoloration, the analysis said….