By Theresa Pablos, DrBicuspid.com associate editor

April 3, 2019 -- The U.S. Food and Drug Administration (FDA) proposed a rule to limit the allowable level of fluoride in bottled water on April 2. The proposed rule would lower the allowable level of fluoride from 0.8 mg/L parts per million (ppm) to 0.7 mg/L ppm.

Susan Mayne, PhD
Susan Mayne, PhD. Image courtesy of the FDA.

The proposed limit is the same as the level set by the U.S. Department of Health and Human Services (HHS) for community water systems in 2015. If finalized, the rule would apply to fluoride added to both imported and domestically packaged bottled water. However, it would not apply to fluoride levels naturally occurring in source water.

"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," stated Susan Mayne, PhD, director of FDA's Center for Food Safety and Applied Nutrition, in a press release. "That's why today we are taking this step to lower the amount of fluoride in bottled water if added by manufacturers."

Designed to account for new fluoride sources

In 2015, HHS recommended a single level of fluoride of 0.7 mg/L ppm to replace the previously recommended range of 0.7 mg/L to 1.2 mg/L. The new limit was designed to account for the additional sources of fluoride that Americans did not have access to when the original range was set in the 1960s. Similarly, the proposed limit on fluoride in bottled water is designed to prevent tooth decay while reducing the likelihood of dental fluorosis, according to Mayne.

"Striking the right balance is especially important for children under the age of 8 as their permanent teeth are still forming," she stated.

Many bottled water manufacturers already complied with the reduced fluoride level when HHS made the change to community water systems four years ago, the FDA noted. However, the new rule would formalize the regulation.

There is currently a 60-day comment period when stakeholders and the public can share comments on the proposed change before the rule is finalized.

"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," Mayne stated. "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."


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