April 2, 2019
“Fluoride provides an important public health benefit by helping to reduce cavities and tooth decay. But too much fluoride over a long time when teeth are forming under the gums can cause changes in the appearance of tooth enamel, called dental fluorosis. Striking the right balance is especially important for children under the age of 8 as their permanent teeth are still forming. 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. “Most fluoride added to bottled water is already at or below the limit being proposed. Today’s action, if finalized, is a step toward helping to ensure that bottled water strikes the right fluoride balance by setting out requirements that manufacturers who add fluoride to bottled water must adhere to. By lowering the allowable level of fluoride in bottled water following its addition by the manufacturer, we can help ensure that consumers enjoy the important health benefits of fluoride while preventing overexposure.”
The U.S. Food and Drug Administration today 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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.