FDA proposes updated rules for fluoride added to bottled water

The US Food and Drug Administration (FDA) is proposing to revise its rules on fluoride levels added to bottled water.

If finalised, the new regulations would amend the allowable levels of fluoride added to bottled water to 0.7 milligrams per litre.

The proposed rule would not affect the allowable levels for fluoride in bottled water to which fluoride is not added by the manufacturer but which may contain fluoride from its source water.

The FDA said the proposal is based on findings from research on optimal concentrations of fluoride that balances its benefits in preventing tooth decay with its risk of causing dental fluorosis, a condition most often characterised by white patches on teeth.

If adopted, the rule will align with the recommended level of 0.7 milligrams per litre set forth by the US Public Health Service (PHS) for community water in 2015. At that time, the FDA also advised the bottled water industry that the PHS recommendations should be considered for their products as well.

Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition, said: “Fluoride provides an important public health benefit by helping to reduce cavities and tooth decay. But too much fluoride over a long time when teeth are forming under the gums can cause changes in the appearance of tooth enamel, called dental fluorosis. Striking the right balance is especially important for children under the age of eight as their permanent teeth are still forming.

“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. That’s why today we are taking this step to lower the amount of fluoride in bottled water if added by manufacturers.”

She added: “Most fluoride added to bottled water is already at or below the limit being proposed. Today’s action, if finalised, 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.”

The proposed rule provides a 60-day period for the public, industry and other stakeholders to share comments with the FDA.