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FDA Proposes New Fluoride Limits for Bottled Water

On April 3, 2019, the Food and Drug Administration (FDA) released a proposed rule that lowers the maximum amount of fluoride allowed in some bottled water products. If finalized, the rule would place an upper limit of 0.7 milligrams per liter of fluoride in bottled water to which fluoride is added. The proposed limits would apply to both imported and domestically bottled water with added fluoride.

This move was prompted by a 2015 report by the U.S. Public Health Service (PHS), which revised the recommended optimal fluoride concentration for public drinking water systems. The 2015 report considered advances in scientific understanding of the effects of fluoridated water that were discovered since the last time PHS issued similar recommendations in 1962. FDA believes that the revised bottled water standards “balances fluoride’s benefits in preventing tooth decay with its risk of causing dental fluorosis, a condition most often characterized by white patches on teeth.”

Under the current bottled water regulations, FDA has different allowable levels of fluoride depending on whether the water is bottled domestically or imported, as well as whether fluoride is added. For domestically bottled water, the allowable levels of fluoride varied based on (1) whether fluoride was added to the water and (2) the annual average maximum daily air temperature at the water source. Imported bottled water can contain up to 1.4 mg/l of fluoride if no fluoride is added, whereas imported water with added fluoride may contain up to 0.8 mg/l.

Under  the proposed rule, domestically bottled water that contains added fluoride will be subject to the same maximum amount – 0.7 mg/l – regardless of the annual average maximum daily air temperature.  Moreover, imported bottled water with added fluoride would be subject to the same maximum value of 0.7 mg/l. At this time, FDA is not proposing to change the maximum fluoride limits for domestic or imported bottled water where fluoride is not added.

The deadline for interested parties to submit public comments to the proposed rule is June 3, 2019.

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