FDA proposes updated standards for fluoride added to bottled water


The U.S. Food and Drug Administration Tuesday released a proposed rule, “Proposed Rule to Revise the Allowable Level of Fluoride in Bottled Water to which Fluoride Has Been Added,” to lower the allowable level of fluoride in bottled water to which fluoride is added by the manufacturer to 0.7 mg/L to be consistent with the 2015 recommendation by the U.S. Public Health Service (PHS) for community water systems that add fluoride for the prevention of dental caries.

This action ensures that consumers receive its dental benefits while avoiding unintentional excess exposure. If finalized, this rule will revise the current allowable levels of fluoride in domestically packaged and imported bottled water to which fluoride is added by the manufacturer.

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

The FDA is issuing this proposed rule as part of a formal process to revise the standards for bottled water with added fluoride. If adopted, this rule will align with the recommended level of 0.7 mg/L set forth by PHS for municipal, community water in 2015.

At that time, the FDA also advised the bottled water industry that the PHS’ recommendations should be considered for their products as well. That’s why many manufacturers of bottled water with added fluoride have already taken steps to reduce fluoride levels.

The proposed rule provides a 60-day comment period for the public, industry and other stakeholders to share with the FDA any comments on the proposed revisions. For more information, as well as instructions on how to submit your comments, please visit the federal register.

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