FDA releases final rule for fluoride in bottled water

April 20, 2022

The U.S. Food and Drug Administration issued its final rule on April 20 for added fluoride levels in bottled water.

The final rule amends the allowable level for fluoride in domestically packaged and imported bottled water to which fluoride is added to 0.7 milligrams per liter (mg/L).

The maximum added fluoride level in the final rule is consistent with the current recommendation by the U.S. Public Health Service (PHS) for the fluoride concentration in community water systems that add fluoride to their water.

This final rule revises the current allowable levels, which range from 0.8 to 1.7 mg/L, for fluoride in domestically packaged and imported bottled water to which fluoride is added. The FDA is taking this action to make the quality standard regulation for fluoride added to bottled water consistent with the 2015 recommendation by PHS for community water systems that add fluoride for the prevention of dental caries.

The action will not affect the allowable levels for fluoride in bottled water to which fluoride is not added by the manufacturer (such bottled water may contain fluoride from its source water).

Water wells, artesian water, and springs are significant sources of bottled water.

The final rule will become effective June 19, 2022, and the compliance date for industry is October 17, 2022.

Click here to read the final rule.

NGWA has a best suggested practice, Reducing Problematic Concentrations of Fluoride in Residential Water Wells, which is free for members to access.