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Bottled Water and Fluoride

Bottled water may or may not have enough fluoride to prevent tooth decay and promote oral health. Some bottled waters contain fluoride, and some do not. Fluoride can occur naturally in source waters used for bottling or it can be added. This fact sheet answers common questions about bottled water and fluoride.

Who regulates bottled water?
The U.S. Environmental Protection Agency (EPA) regulates public drinking water (tap water), and the U.S. Food and Drug Administration (FDA) regulates bottled water products under the authority of the Federal Food, Drug, and Cosmetic Act. For more information, please visit the FDA bottled water fact sheet for consumers.

Does bottled water contain fluoride?
Bottled water products may contain fluoride, depending on the source of the water. Fluoride can be naturally present in the original source of the water, and many public water systems add fluoride to their water. FDA sets limits for fluoride in bottled water, based on several factors, including the source of the water. Bottled water products labeled as de-ionized, purified, demineralized, or distilled have been treated in such a way that they contain no or only trace amounts of fluoride, unless they specifically list fluoride as an added ingredient.

Is the amount of fluoride in bottled water listed on the label?

The FDA does not require bottled water manufacturers to list the amount of fluoride on the label unless the manufacturer has added fluoride within set limits.

How can I find out the level of fluoride in bottled water?
Contact the bottled water's manufacturer to ask about the fluoride content of a particular brand.

What FDA regulations for bottled water relate to fluoride?
As set forth in 21 CFR 165.110, FDA has established standards for the maximum amount of naturally occurring fluoride or added fluoride allowed in bottled drinking water. These levels are available here.

If bottled water meets specific standards of identity and quality set forth by FDA, and the provisions of the authorized health claim, manufacturers may include the following health claim: “Drinking fluoridated water may reduce the risk of [dental caries or tooth decay].” For more information, see Health Claim Notification for Fluoridated Water and Reduced Risk of Dental Caries.

Can I use bottled water for mixing infant formula?
Yes, you can use bottled water to reconstitute (mix) powdered or liquid concentrate infant formulas, but be aware that the fluoride content in bottled water varies. If your child is exclusively consuming infant formula reconstituted with water that contains fluoride, there may be an increased chance for mild dental fluorosis (a change in the appearance of tooth enamel creating barely visible lacy white markings). To lessen this chance, parents may choose to use low-fluoride bottled water some of the time to mix infant formula. These bottled waters are labeled as de-ionized, purified, demineralized, or distilled and are without any fluoride added after purification treatment (FDA requires the label to indicate when fluoride is added). Some water companies make available bottled waters marketed for infants and for the purpose of mixing with formula. When water is labeled as intended for infants, the water must meet tap water standards established by the EPA and indicate that the water is not sterile. For more information, see CDC’s Overview: Infant Formula and Fluorosis and FDA’s general Q&A about bottled water and infant formula.


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