FDA Issues Final Rule Revising Fluoridation Standards for Bottled Water

  • by AGD Washington Advocacy Representative
  • May 12, 2022
The Food and Drug Administration (FDA) issued a final rule revising the quality standard for the amount of manufacture-added fluoride permitted in bottled water from 0.8 mg/L ppm to 0.7 mg/L ppm. The rule brings the allowable amount of manufacture-added fluoride in bottled water in line with the U.S. Public Health Service’s (PHS) updated recommendation for optimal fluoride concentration of community water systems. The final rule has no effect on the amount of fluoride permitted in bottled water that naturally contains fluoride from its source.

The PHS updated its fluoride standards for community water systems in 2015 and many bottled water producers have already taken steps to bring their products in line with that standard. The rule seeks to balance fluoride’s benefits in preventing tooth decay with its risk of causing dental fluorosis. 

The final rule takes effect on June 21, 2022. The compliance date for industry is October 17, 2022.

Impact on General Dentistry: The AGD has long supported water fluoridation as a safe and effective way to combat tooth decay. Harmonizing bottled water fluoride standards with community water fluoride standards is a logical action to maintain regulatory consistency.