Since bottled water is regulated by the U.S. Food and Drug Administration (FDA), it is the FDA that sets the limit as to the amount of fluoride that bottlers are allowed to add to their products according to 21 CFR § 165.110 of the Code of Federal Regulations. Bottled water packaged in the U.S., to which no fluoride has been added, shall not contain fluoride in excess of the levels in List 1* and these levels are based on the annual average of maximum daily air temperatures at the location where the bottled water is sold at retail. Imported bottled water, to which no fluoride has been added, shall not contain fluoride in excess of 1.4 milligrams per liter. Bottled water packaged in the U.S., to which fluoride has been added, shall not contain fluoride in excess of levels in List 2** and these levels are based on the annual average of maximum daily air temperatures at the location where the bottled water is sold at retail.

In that bottled water is a food product, it is subject to the Nutrition Labeling Education Act (NLEA), which would require that, with added fluoride, a bottled water label must contain related NLEA data. If a consumer has additional questions beyond what may be found on a label, they may contact a bottler directly.

For a list of IBWA member companies that produce fluoridated bottled water, visit the IBWA web site at www.bottledwater.org/public/fluorida.htm.

FDA fluoride standards for bottled water are:

* List 1: (naturally occurring/no fluoride added)

Annual average of maximum daily air temperatures (°F) - 53.7 and below
Fluoride concentration in milligrams per liter - 2.4

Annual average of maximum daily air temperatures (°F) - 53.8 - 58.3
Fluoride concentration in milligrams per liter - 2.2

Annual average of maximum daily air temperatures (°F) - 58.4 - 63.8
Fluoride concentration in milligrams per liter - 2.0

Annual average of maximum daily air temperatures (°F) - 63.9 - 70.6
Fluoride concentration in milligrams per liter - 1.8

Annual average of maximum daily air temperatures (°F) - 70.7 - 79.2
Fluoride concentration in milligrams per liter - 1.6

Annual average of maximum daily air temperatures (°F) - 79.3 - 90.5
Fluoride concentration in milligrams per liter - 1.4

* List 2 (fluoride added)

Annual average of maximum daily air temperatures (°F) - 53.7 and below
Fluoride concentration in milligrams per liter - 1.7

Annual average of maximum daily air temperatures (°F) - 53.8 - 58.3
Fluoride concentration in milligrams per liter - 1.5

Annual average of maximum daily air temperatures (°F) - 58.4 - 63.8
Fluoride concentration in milligrams per liter - 1.3

Annual average of maximum daily air temperatures (°F) - 63.9 - 70.6
Fluoride concentration in milligrams per liter - 1.2

Annual average of maximum daily air temperatures (°F) - 70.7 - 79.2
Fluoride concentration in milligrams per liter - 1.0

Annual average of maximum daily air temperatures (°F) - 79.3 - 90.5
Fluoride concentration in milligrams per liter - 0.8

-- There is no correlation between the increased consumption of bottled water and an increase in cavities. In fact, bottled water does not contain ingredients that cause cavities.

-- The bottled water industry offers both fluoridated and non-fluoridated brands to provide consumers with choice, quality and convenience. A number of IBWA-member companies produce fluoridated bottled water for consumers who want fluoride in their drinking water and wish to choose bottled water. A number of IBWA-member companies produce fluoridated bottled water, visit the IBWA web site at www.bottledwater.org/public/fluorida.htm. For a full list of IBWA member brands, visit www.bottledwater.org.

-- 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.

-- 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 contact their health care or dental care provider for their recommendation. Exposure to higher than recommended levels of fluoride can lead to a condition called fluorosis, which can result in stains to the teeth.

-- The bottled water industry is comprehensively regulated as a packaged food product by the U.S. Food and Drug Administration (FDA), which mandates stringent standards to help ensure bottled water's consistent safety, quality and good taste. By law, FDA bottled water standards must be at least as stringent and protective of public health as U.S. Environmental Protection Agency (EPA) tap water standards. FDA requires bottled water to comply with bottled water-specific safety and health standards, as well as regulations required of all food products.

-- Bottled water products are required to comply at all times with FDA Standards of Quality. As with other food products, bottled water is subject to the food adulteration and misbranding requirements of the Federal Food, Drug, and Cosmetic Act and is subject to the full array of FDA enforcement actions including warning letters, civil (seizure and/or injunction) and criminal penalties. As with other food products, bottled water may be recalled from the marketplace.

www.bottledwater.org