Consumers drink bottled water for various reasons, including as a taste
preference or as a convenient means of hydration. Bottled water may not
have a sufficient amount of fluoride, which is important for preventing
tooth decay and promoting 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 fluoride in bottled water?
The Federal Food, Drug, and Cosmetic Act provides the U.S. Food and Drug
Administration (FDA) broad regulatory authority over food, including bottled
water, which is introduced or delivered for interstate commerce (produced
and sold in more than one state). Bottled water that is in intrastate
commerce is under the jurisdiction of the state in which the bottled water
is produced and sold. Contact the manufacturer to ask if their product is
under FDA jurisdiction or state jurisdiction.
Why doesn’t the EPA have jurisdiction over the quality of bottled
water since it regulates drinking water?
The Environmental Protection Agency (EPA) and the FDA have a 1979 Memorandum
of Agreement specifying that the EPA regulates safe drinking water in
accordance with the Safe Drinking Water Act, and that the FDA regulates
bottled water as a consumer beverage under the Food, Drug, and Cosmetic Act
(Federal Register, Volume 44, No. 141, July 20, 1979).
What FDA regulations apply to bottled water?
The FDA has strict regulations on standards of quality, identity, and good
manufacturing practices that bottled water must meet. Its regulations for
governing the standards of “quality and identity” for bottled water are
found in the Code of Federal Register 21 CFR 165.110. The FDA standards of
quality state that domestic bottled water with no added fluoride may contain
between 1.4 and 2.4 milligrams per liter (mg/L) fluoride, depending on the
annual average daily air temperatures at the location where the bottled
water is sold. Domestic bottled water with added fluoride can contain
between 0.8 and 1.7 mg/L fluoride, depending on the annual average daily air
temperatures where the bottled water is sold. Imported bottled water with no
added fluoride may not contain more than 1.4 mg/L fluoride, and imported
bottled water with added fluoride may not contain more than 0.8 mg/L
Is the amount of fluoride in bottled water always listed on the
The FDA does not require bottled water manufacturers to list the fluoride
content on the label, but it does require that fluoride additives be listed.
In 2006, the FDA approved labeling with the statement, “Drinking fluoridated
water may reduce the risk of tooth decay,” if the bottled water contains
from 0.6 mg/L to 1.0 mg/L.
How can I find out the level of fluoride in bottled water if it’s
not on the label?
Contact the bottled water’s manufacturer to ask about the fluoride
content of a particular brand.
Does drinking bottled water without fluoride lead to more
Your oral health—specifically, how many cavities you have—depends on many
factors, one of which is how much fluoride you receive in the form of
toothpaste, mouthwash, water, food, and professional fluoride products
applied by dental professionals. Other factors include how often and how
thoroughly you brush your teeth and floss, what you eat, and whether you
receive regular dental care. If you mainly drink bottled water with no or
low fluoride, and you are not getting enough fluoride from other sources,
you may get more cavities than you would if fluoridated tap water were your
main water source.
Will the fluoride content change if the bottled water is stored
for a long time?
Fluoride will not react with other minerals present in the water during
storage, nor will it react with its plastic or glass container. The FDA
considers bottled water to be safe indefinitely if produced in accordance
with quality standard regulations, and if stored in an unopened, undamaged,
and properly sealed container. Many bottlers list an expiration date,
however. Note that if there is no expiration date, bottled waters should not
be used more than two years after the date of purchase because the packaging
may have hard-to-see deterioration.
Can I use bottled water for mixing infant formula?
Yes, you can reconstitute (mix) powdered or liquid concentrate formulas with
bottled waters, 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. To lessen
this chance, parents can use low-fluoride bottled water some of the time to
mix infant formula. These bottled water products are labeled as de-ionized,
purified, demineralized, or distilled, unless they specifically list
fluoride as an added ingredient. For more information, see
Overview: Infant Formula and
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Date last reviewed:
January 7, 2011
Date last updated: January 7, 2011
Division of Oral Health,
National Center for Chronic Disease Prevention and