© 2025 American Dental Association l 81
Fluoridation Facts
47. Who regulates drinking water additives in United States?
Answer
The EPA regulates drinking water additives.
Fact
In 1974, Congress passed the Safe Drinking Water Act (SDWA), which protects the public’s health by
regulating the nation’s public drinking water supply.197 The SDWA, as amended in 1986 and 1996, requires
the EPA to ensure that the public is provided with safe drinking water.197 On June 22, 1979, the FDA and the
EPA entered into a Memorandum of Understanding (MOU) to clarify their roles and responsibilities in water
quality assurance.363 The stated purpose of the MOU is to “avoid the possibility of overlapping jurisdiction
between the EPA and FDA with respect to control of drinking water additives.” The two agencies agreed
that SDWA passage in 1974 implicitly repealed FDA’s jurisdiction over drinking water as a “food” under the
Federal Food, Drug, and Cosmetic Act (FFDCA). Under the MOU, the EPA has exclusive regulatory authority
over drinking water provided by public water systems, including any additives in such water.363
While drinking water from the tap is regulated by the EPA, the FDA retains jurisdiction over bottled
drinking water under Section 410 of the FFDCA and “water (and substances in water) used in food
or food processing once it enters the food processing establishment.”363 The FDA has established
standards for bottled water quality.363 The FDA has noted that fluoride can occur naturally in source
waters used for bottled water or can be added by a bottled water manufacturer. Recognizing the
benefits of fluoride in water, the FDA has stated that bottled water that meets specific standards of
identity (regulations that define different types of bottled water) and quality set forth by FDA, and the
provisions of the authorized health claim related to fluoride, can be labeled with the following health
claim: “Drinking fluoridated water may reduce the risk of [dental caries or tooth decay].”169
While drinking water from the tap is regulated by the EPA, bottled water is
regulated by the FDA, which has established standards for its quality.
From time to time, states and communities have had to deal with legislation or ballot initiatives
aimed at requiring FDA approval before any agent can be added to community water systems. Often
referred to as the Fluoride Product Quality Control Act, Water Product Quality Ordinance, or Pure
Water Ordinance, the legislation is specifically used by those opposed to water fluoridation as a tool to
prevent water systems from providing community water fluoridation. Often this legislation does not
specifically mention fluoride or fluoridation. Those supporting this type of legislation may claim that
they are not against water fluoridation but are proponents of pure water, and do not want anything
added to water that has not been approved by the FDA. On the surface, this appears to be a “common
sense” approach. However, its only real purpose is to defeat efforts to provide water fluoridation.
That is because this proposed legislation would require the FDA—which does not regulate public water
systems—to approve any water additive. By mistakenly (and perhaps craftily) naming the wrong
federal agency, the desired outcome is to stop or prevent water fluoridation.
Fluoridation Practice
Section 3
Fluoridation Facts
47. Who regulates drinking water additives in United States?
Answer
The EPA regulates drinking water additives.
Fact
In 1974, Congress passed the Safe Drinking Water Act (SDWA), which protects the public’s health by
regulating the nation’s public drinking water supply.197 The SDWA, as amended in 1986 and 1996, requires
the EPA to ensure that the public is provided with safe drinking water.197 On June 22, 1979, the FDA and the
EPA entered into a Memorandum of Understanding (MOU) to clarify their roles and responsibilities in water
quality assurance.363 The stated purpose of the MOU is to “avoid the possibility of overlapping jurisdiction
between the EPA and FDA with respect to control of drinking water additives.” The two agencies agreed
that SDWA passage in 1974 implicitly repealed FDA’s jurisdiction over drinking water as a “food” under the
Federal Food, Drug, and Cosmetic Act (FFDCA). Under the MOU, the EPA has exclusive regulatory authority
over drinking water provided by public water systems, including any additives in such water.363
While drinking water from the tap is regulated by the EPA, the FDA retains jurisdiction over bottled
drinking water under Section 410 of the FFDCA and “water (and substances in water) used in food
or food processing once it enters the food processing establishment.”363 The FDA has established
standards for bottled water quality.363 The FDA has noted that fluoride can occur naturally in source
waters used for bottled water or can be added by a bottled water manufacturer. Recognizing the
benefits of fluoride in water, the FDA has stated that bottled water that meets specific standards of
identity (regulations that define different types of bottled water) and quality set forth by FDA, and the
provisions of the authorized health claim related to fluoride, can be labeled with the following health
claim: “Drinking fluoridated water may reduce the risk of [dental caries or tooth decay].”169
While drinking water from the tap is regulated by the EPA, bottled water is
regulated by the FDA, which has established standards for its quality.
From time to time, states and communities have had to deal with legislation or ballot initiatives
aimed at requiring FDA approval before any agent can be added to community water systems. Often
referred to as the Fluoride Product Quality Control Act, Water Product Quality Ordinance, or Pure
Water Ordinance, the legislation is specifically used by those opposed to water fluoridation as a tool to
prevent water systems from providing community water fluoridation. Often this legislation does not
specifically mention fluoride or fluoridation. Those supporting this type of legislation may claim that
they are not against water fluoridation but are proponents of pure water, and do not want anything
added to water that has not been approved by the FDA. On the surface, this appears to be a “common
sense” approach. However, its only real purpose is to defeat efforts to provide water fluoridation.
That is because this proposed legislation would require the FDA—which does not regulate public water
systems—to approve any water additive. By mistakenly (and perhaps craftily) naming the wrong
federal agency, the desired outcome is to stop or prevent water fluoridation.
Fluoridation Practice
Section 3
