December 08, 2006

The US Food and Drug Administration (FDA) on October 14, 2006 determined that bottled water producers may include the following health claim on brands containing fluoride, "Drinking fluoridated water may reduce the risk of [dental caries or tooth decay]." The health claim is not intended for use on bottled water products specifically marketed for use by infants. FDA based its action on an authoritative statement from an appropriate scientific body of the United States Government or the National Academy of Sciences (NAS) or any of its subdivisions. Bottled water is regulated as a packaged food product by FDA.

To read the full FDA statement online, visit

To bring clarity to this issue from the perspective of the dental community, ADA on November 9, 2006 released an interim guidance document on the use of fluoridated bottled water. The "Interim Guidance on Fluoride Intake for Infants and Young Children" clearly did not advise against the use of bottled water containing fluoride. It recommended that consumers who choose to feed infants using liquid concentrate or powdered infant formula and wish to use bottled water select a brand that is "fluoride free or contains low levels of fluoride." This guidance was offered for parents of infants-defined as children ages 12 months and younger-and did not advise against serving bottled water with fluoride to children older than one year. ADA also clearly stated that, "The occasional use of water containing optimal levels of fluoride should not appreciably increase a child's risk for fluorosis."

Key information contained in the ADA guidance document states:

  • Breast milk is widely acknowledged as the most complete form of nutrition for infants. The American Academy of Pediatrics recommends human milk for all infants (except for the few for whom breastfeeding is determined to be harmful).
  • For infants who get most of their nutrition from formula during the first 12 months, ready-to-feed formula is preferred to help ensure that infants do not exceed the optimal amount of fluoride intake.
  • If liquid concentrate or powdered infant formula is the primary source of nutrition, it can be mixed with water that is fluoride free or contains low levels of fluoride to reduce the risk of fluorosis. Examples are water that is labeled purified, demineralized, deionized, distilled or reverse osmosis filtered water. Many grocery stores sell these types of drinking water for less than $1 per gallon.
  • More research is needed before definitive recommendations can be made on fluoride intake by bottle-fed infants.
  • Enamel fluorosis is not a disease but rather affects the way that teeth look.
  • The occasional use of water containing optimal levels of fluoride should not appreciably increase a child's risk for fluorosis."

To read the ADA Interim Guidance on Infant Formula and Fluoride in its entirety, log onto:

IBWA supports FDA's decision to permit bottled water to carry health information related to fluoride so that consumers can make informed decisions about their bottled water-and drinking water-choices. For consumers who want fluoride in their drinking water and want to choose bottled water, the FDA decision on fluoride labeling allows bottlers to inform consumers about certain healthful attributes of that specific brand. However, not all consumers wish to drink water with fluoride or get their fluoride from other sources.

IBWA encourages consumers to consider the following facts about bottled water and fluoride:

  • The bottled water industry provides consumers with a wide range of choices based on their specific needs. As a result, bottled water is available in both fluoridated and non-fluoridated brands. A number of IBWA-member companies produce fluoridated bottled water, visit the IBWA web site at For a full list of IBWA member brands, visit
  • There are many sources of fluoride, and the amount of fluoride exposure varies greatly by community and individual. Consumers should consider how much fluoride they are receiving as part of their overall diet and consult with their dental or health care provider for their recommendation.

For more facts about bottled water regulations, safety, fluoride and other bottled water topics, visit