Beverages: Bottled Water, Final Rule

The Food and Drug Administration (FDA or we) is revising the quality standard for bottled water to specify that bottled water to which fluoride is added by the manufacturer may not contain fluoride in excess of 0.7 milligrams per liter (mg/L), which available data suggests provides an optimal balance between the prevention of dental caries and the risk of dental fluorosis. 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. We are taking this action to make the quality standard regulation for fluoride added to bottled water consistent with the 2015 recommendation by the US Public Health Service (PHS) for community water systems that add fluoride for the prevention of dental caries. This 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). This rule is effective 21 June 2022. The compliance date is 17 October 2022.