FDA proposes revision on fluoride addition to bottled water

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.

The U.S. Food and Drug Administration 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. 

“It’s the FDA’s responsibility to ensure that if fluoride is added to bottled water, it is added at appropriate levels so that consumers receive its important health benefit while also being protected from potential adverse effects. That’s why today we are taking this step to lower the amount of fluoride in bottled water if added by manufacturers. This proposed rule would align the limits for fluoride with the updated recommendation by the U.S. Public Health Service for community water systems that add fluoride, a recommendation that provides an optimal balance between the prevention of dental caries and the risk of dental fluorosis,” said Susan Mayne, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition.  

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.