FDA Releases Final Rule for Added Fluoride Levels in Bottled Water
April 19, 2022
Today the U.S. Food and Drug Administration issued its final rule for added fluoride levels in bottled water titled Beverages: Bottled Water. This final rule amends the allowable level for fluoride in domestically packaged and imported bottled water to which fluoride is added to 0.7 milligrams per liter (mg/L). The proposed rule published in April 2019.
The maximum added fluoride level in the final rule is consistent with the current recommendation by the U.S. Public Health Service (PHS) for the fluoride concentration in community water systems that add fluoride to their water. This maximum level will balance prevention of tooth decay and the risk of fluoride overexposure. This final rule does not affect bottled water that contains only naturally occurring fluoride (i.e., not added by a manufacturer). Added fluoride must be declared in the ingredient list, so consumers can examine bottled water labeling to determine whether fluoride has been added.
The final rule will become effective June 19, 2022, and the compliance date for industry is October 17, 2022.
Background documents and comments on the proposed rule can be accessed online at https://www.regulations.gov using Docket No. FDA-2018-N-1815 or via the Dockets Management Staff at 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For More Information
- Federal Register for the Final Rule
- Letter to Manufacturers, Distributors, or Importers of Bottled Water with an Update on Fluoride Added to Bottled Water 2015
- FDA In Brief 2019
- Federal Register Notice for the Proposed Rule (2019)
- Bottled Water/Carbonated Soft Drinks Guidance Documents & Regulatory Information