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  6. Letter to Manufacturers, Distributors, or Importers of Bottled Water with an Update on Fluoride Added to Bottled Water
  1. Bottled Water/Carbonated Soft Drinks Guidance Documents & Regulatory Information

Letter to Manufacturers, Distributors, or Importers of Bottled Water with an Update on Fluoride Added to Bottled Water

Bottled Water Guidance

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Public Health Service
Food and Drug Administration
College Park, MD 20740

April 27, 2015

Dear Manufacturer, Distributor, or Importer of Bottled Water: 

The Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition is providing you with an update on fluoride added to bottled water. The U.S. Public Health Service (PHS) recently recommended an optimal fluoride concentration of 0.7 mg/L (parts per million [ppm]) for community water systems that are currently fluoridating or will initiate fluoridation of their water to maintain dental caries prevention benefits and reduce the risk of dental fluorosis.[1]  In keeping with this PHS recommendation, FDA recommends that bottled water manufacturers do not add fluoride to bottled water at concentrations greater than a maximum final concentration of 0.7 mg/L.

Fluoride can occur naturally in source waters used for bottled water or may be added by a bottled water manufacturer. FDA regulations include a quality standard for bottled water; this standard, which is found at 21 CFR 165.110(b), provides for different allowable levels for added and naturally occurring fluoride, as well as for imported and domestic products (21 CFR 165.110(b)(4)(ii)). Under this quality standard, for bottled water with added fluoride, domestic bottled water can contain between 0.8 and 1.7 milligrams per liter (mg/L) fluoride, depending on annual average air temperatures at the location where the bottled water is sold at retail, and imported bottled water cannot contain more than 0.8 mg/L fluoride. Our recommendation -- that bottled water manufacturers do not add fluoride to bottled water at concentrations greater than a maximum final concentration of 0.7 mg/L -- does not affect the current allowable levels of fluoride in bottled water specified in FDA’s quality standard for bottled water.

The recent PHS recommendation replaces a previous PHS recommendation for fluoride concentrations that ranged from 0.7-1.2 mg/L and was based on outdoor air temperature of geographic areas. The allowable level for added fluoride in bottled water in FDA’s bottled water regulations was based on the previous PHS recommendation. We intend to revise the quality standard for fluoride added to bottled water in 21 CFR 165.110(b)(4)(ii) to be consistent with the updated PHS recommendation. In the interim, we recommend that bottled water manufacturers do not add fluoride to bottled water at concentrations greater than a maximum final concentration of 0.7 mg/L. 

Sincerely, 

/S/

Susan T. Mayne, Ph.D, F.A.C.E.
Director
Center for Food Safety and Applied Nutrition

[1]The PHS recommendation does not change the Maximum Contaminant Level for fluoride in public drinking water, which is set by the U.S. Environmental Protection Agency.

More information on the PHS recommendations can be found on the Public Health Reports website disclaimer icon.

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