In mid-October, the US Food and Drug Administration (FDA) issued a new health claim notification allowing manufacturers of bottled water with fluoride to claim that drinking fluoridated water may reduce the risk of dental caries. According to the FDA, manufacturers may use this health claim for bottled water “containing greater than 0.6 and up to 1.0 mg/L total fluoride.”
The FDA’s Center for Food Safety and Applied Nutrition regulates bottled water as a food, and has a formal process for authorizing health claims for food products. The health claim for bottled water with fluoride is particularly important because most commercially available bottled waters do not contain optimal fluoride levels for caries prevention. Although some bottled-water products are optimally fluoridated, fluoride levels in bottled water vary considerably and most fall below 0.7 mg/L. The FDA’s approval of the bottled-water health claim allows manufacturers to promote the benefits of optimally fluoridated water, improve consumer understanding of its value, and enable purchasers to better identify bottled-water products with optimal fluoride levels.
In authorizing the health claim for bottled water, the FDA cited scientific statements from the Centers for Disease Control and Prevention, the US Public Health Service, and the 2000 Surgeon General’s Oral Health in America report supporting water fluoridation for caries prevention. The FDA also noted that the new health claim is not intended for use on bottled-water products marketed for use by infants.
Based on the available peer-reviewed evidence, the ADA supports water fluoridation within the optimum range of 0.7 to 1.2 ppm as a safe and effective means of caries prevention. The ADA encourages dentists to educate their patients regarding the level of fluoride in bottled water and the possible removal of fluoride by some home water treatment systems. The ADA also urges dentists to inquire about their patients’ primary and secondary water source as part of their health history.
For additional information, visit www.ada.org.
[www.ada.org, October 30, 2006]