First email to the FDA

FDA logoI sent an email in 2013 asking the FDA if they classed fluoridated water as a drug. This is what they replied.

Dear Mr. Ryan,

Thank you for your message to the Division of Drug Information at the Center for Drug Evaluation and Research (CDER), within the Food and Drug Administration (FDA).

With respect to fluoridated bottled water, please refer to our statement “Health Claim Notification for Fluoridated Water and Reduced Risk of Dental Caries”: http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm073602.htm

As excerpted from this statement “the food eligible to bear the claim is bottled water meeting the standards of identity and quality set forth in 21 CFR 165.110, containing greater than 0.6 and up to 1.0 mg/L total fluoride, and meeting all general requirements for health claims (21 CFR 101.14) with the exception of minimum nutrient contribution (21 CFR 101.14 (e)(6)). The claim language is: “Drinking fluoridated water may reduce the risk of

[dental caries or tooth decay].”

Best regards,

Drug Information Specialist, LK |Division of Drug Information

Center for Drug Evaluation and Research |Food and Drug Administration

Second email to the FDA

I asked the same question but referring specifically to tap water. This is their response:

Dear Mr. Ryan,

Please know, the FDA does not regulate the quality of water, including water fluoridation, as this is regulated by the United States Environmental Protection Agency (EPA). You may find information on their website about water purification processes,

http://water.epa.gov/drink/standardsriskmanagement.cfm and fluoride in drinking water,

http://water.epa.gov/drink/contaminants/basicinformation/fluoride.cfm.

The EPA Office of Water may also be contacted directly by mail at:

U.S. Environmental Protection Agency

Office of Water (4100T)

1200 Pennsylvania Avenue, N.W.

Washington, D.C. 20460

Best regards,

Drug Information Specialist, LK |Division of Drug Information

Center for Drug Evaluation and Research |Food and Drug Administration

First Email to the EPA

EPA LogoI then contacted the EPA on their ticket support system with the same question. Darieus ZaGara replied as below:

Good evening,

Thank you for contacting the Safe Drinking Water Hotline. You had some concerns regarding fluoride. Please review the information included below:

EPA sets limits on contaminants. Whether fluoride is present in a local water system because of the natural erosion of minerals or used as an additive (this is determined by local authorities, not EPA), EPA regulates the amount present to keep potable water safe by ensuring contaminants, fluoride or otherwise, do not exceed their Maximum Contaminant Levels.

EPA’s Safe Drinking Water Hotline answers questions about the regulations and programs developed in response to the Safe Drinking Water Act. The Safe Drinking Water Hotline provides information, including access to publications, on EPA’s drinking water standards, source water protection, and underground injection wells. The Hotline also provides referrals to state public water supply supervision programs, state underground injection control programs, and state laboratory certification programs.

If you have additional questions, you may contact the Safe Drinking Water Hotline at the following number:

(800) 426-4791 — Toll Free

For more information, please visit EPA’s Office of Ground Water and Drinking Water Internet web site:

http://water.epa.gov/drink/index.cfm.

Thank you for your interest in safe drinking water.

Second email to the EPA

Then I asked to clarify if it was a drug/medicine. He responded again as follows:

Fluoride can be naturally occurring in the environment. Of course it is also used as an additive too-again, this is a decision handled upon the local level. Whether fluoride, in its additive form, is classified as a drug is not within the realm of EPA. EPA sets federal laws that restrict the concentration of water contaminants in order to protect the health of people long-term.

Conclusion

Neither the FDA or the EPA will class it as a drug or not.