FDA Issues a Letter for Manufacturers with Recommendations on Fluoride Added to Bottled Water

April 27, 2015

In concert with a new U.S. Public Health Service (PHS) recommendation for fluoride levels in community water systems, the U.S. Food and Drug Administration (FDA) has letter to industry recommending that bottled water manufacturers, distributors and importers limit the amount of fluoride they add to bottled water so that it contains no more than 0.7 milligrams per liter (mg/L). The new PHS recommendation was developed by a panel of scientists from several federal agencies, who undertook an extensive review of the scientific literature on the relationship between fluoride intake and oral health.

Fluoride prevents tooth decay (dental caries) in children and adults. But children exposed to excessive amounts of fluoride have an increased risk of developing discoloration of their tooth enamel (dental fluorosis).

The PHS recommendation replaces a previous recommendation for fluoride concentrations that ranged from 0.7-1.2 mg/L, and is designed to achieve an optimal fluoride level that provides the best balance of protection from dental caries while limiting the risk of dental fluorosis. More information on the PHS recommendations can be found on the Public Health Reports website.

FDA’s recommendation is specific to fluoride that is added to bottled water and does not affect the levels of fluoride permitted under FDA’s bottled water regulations.