FDA Sets Maximum Fluoride Levels For Bottled Water

The FDA says the new maximum fluoride levels rule allows enough to help prevent tooth decay, while preventing side effects from too much fluoride exposure.

A new federal rule lowers the maximum allowed fluoride levels in bottled water, but only by a small amount.

The Food and Drug Administration (FDA) issued the final rule for fluoride on April 19, lowering the allowable level of fluoride from a range of 0.8 to 1.7 milligrams per liter to 0.7 milligrams per liter.

The rule was first proposed last year, and the final draft was published in the Federal Register on April 20, going into effect on June 19 and requiring the bottled water industry to be in compliance by October 17, 2022.

The agency indicates that the maximum added fluoride level is now consistent with the current recommendation by the US Public Health Service for fluoride in community water systems, and does not affect bottled water that contains only naturally occurring fluoride, which is not added by the manufacturer.

Instead, added fluoride must be included in the ingredient list and the terms “fluoridated,” “fluoride added,” or “with added fluoride” must be used on the label if it contains added fluoride.

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The agency said the lowered limit, which is not a significant reduction, helps to balance prevention of tooth decay and the risk of fluoride overexposure, or dental fluorosis. This is marked by white patches on the teeth and is caused from taking in too much fluoride over a period of time when adult teeth are still forming under the gums.

The FDA indicated the change is based on research on optimal concentrations of fluoride. However, some advocates warn the reduction is not sufficient enough, as fluoride can damage brain development and may cause neurotoxicity. Some research has linked lower children’s IQ levels to increased fluoride exposure and indicate using fluoridated toothpaste is sufficient to protect tooth decay.

The agency highlighted the American Dental Association and the American Academy of Pediatrics support of water fluoridation.

Background documents and comments on the proposed final 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.


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