July 2, 2022

Volume XII, Number 183

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FDA Amends Added Fluoride Levels in Bottled Water

  • On April 20, the FDA published a final rule for added fluoride levels in bottled water. The final rule amends the quality standard, and specifies that domestically packaged and imported bottled water to which fluoride has been added may not contain fluoride in excess of 0.7 mg/L. The final rule revises the current allowable levels, which range from 0.8 – 1.7 mg/L.

  • The revised maximum added fluoride level is consistent with the current recommendation by the US Public Health Service (PHS) for the fluoride concentration in community water systems that add fluoride to their water. The chosen maximum level balances the issues of tooth decay prevention and the risk of fluoride overexposure.

  • The final rule reiterates that fluoride added to bottled water must be declared in the ingredient list. In other words, bottled water with added fluoride is a multi-ingredient food. In addition, the terms “fluoridated,” “fluoride added,” or “with added fluoride” may be used on the label or in labeling of bottled water that contains added fluoride.

  • Notably, the final rule does not impact bottled water that contains only naturally occurring fluoride. The FDA decided not to revise the allowable levels for fluoride in bottled water that was not added by the manufacturer because the PHS recommendation does not affect community water systems with naturally occurring fluoride in water at concentrations greater than 0.7 mg/L. The final rule becomes effective on June 19, 2022, and compliance is required by October 17, 2022.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 110
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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