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Beverages: Bottled Water rule (2022)

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The Beverages: Bottled Water rule is a significant rule issued by the Food and Drug Administration (FDA) effective June 21, 2022, that implemented a statutory limit of 0.7 milligrams per liter of added fluoride permitted in bottled water. FDA issued this rule pursuant to their authority under the Federal Food, Drug, and Cosmetic Act.[1]

HIGHLIGHTS
  • Name: Beverages: Bottled Water
  • Action: Final rule
  • Type of significant rule: Other significant rule

    • Timeline

    The following timeline details key rulemaking activity:

    Background

    The U.S. Public Health Service (PHS) issued an updated recommendation in 2015 of an "optimal fluoride concentration of 0.7 mg/L" for community water, according to the text of the Beverages: Bottled Water rule. The Food and Drug Administration (FDA) wrote to bottled water manufacturers the same year recommending only 0.7 milligrams per liter of fluoride be added to bottled water— per PHS' recommendation— and found most manufacturers already complied with the standard. FDA promulgated the Beverages: Bottled Water final rule in 2022 to codify the allowable fluoride levels in bottled water and to reduce consumer confusion about any discrepancy between PHS' fluoride level recommendation and the previous FDA standard.[1]

    Summary of the rule

    The following is a summary of the rule from the rule's entry in the Federal Register:

    “ The Food and Drug Administration (FDA or we) is revising the quality standard for bottled water to specify that bottled water to which fluoride is added by the manufacturer may not contain fluoride in excess of 0.7 milligrams per liter (mg/L), which available data suggests provides an optimal balance between the prevention of dental caries and the risk of dental fluorosis. This final rule revises the current allowable levels, which range from 0.8 to 1.7 mg/L, for fluoride in domestically packaged and imported bottled water to which fluoride is added. We are taking this action to make the quality standard regulation for fluoride added to bottled water consistent with the 2015 recommendation by the U.S. Public Health Service (PHS) for community water systems that add fluoride for the prevention of dental caries. This action will not affect the allowable levels for fluoride in bottled water to which fluoride is not added by the manufacturer (such bottled water may contain fluoride from its source water).[1][2] ”

    Summary of provisions

    The following is a summary of the provisions from the rule's entry in the Federal Register:[1]

    “ The final rule revises the quality standard for bottled water (found in §  165.110(b) (21 CFR 165.110(b)) to set the allowable level for fluoride at 0.7 mg/L in domestically packaged and imported bottled water to which fluoride has been added.[2] ”

    Significant impact

    See also: Significant regulatory action

    Executive Order 12866, issued by President Bill Clinton (D) in 1993, directed the Office of Management and Budget (OMB) to determine which agency rules qualify as significant rules and thus are subject to OMB review.

    Significant rules have had or might have a large impact on the economy, environment, public health, or state or local governments. These actions may also conflict with other rules or presidential priorities. Executive Order 12866 further defined an economically significant rule as a significant rule with an associated economic impact of $100 million or more. Executive Order 14094, issued by President Joe Biden (D) on April 6, 2023, made changes to Executive Order 12866, including referring to economically significant rules as section 3(f)(1) significant rules and raising the monetary threshold for economic significance to $200 million or more.[1]


    The text of the rule states that OMB deemed this rule significant, but not economically significant:

    “ This final rule has been designated by the Office of Information and Regulatory Affairs as a significant regulatory action as defined by Executive Order 12866.[2] ”

    Text of the rule

    The full text of the rule is available below:[1]

    See also

    External links

    Footnotes

    1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 Federal Register, "Beverages: Bottled Water," February 28, 2024.
    2. ↑ 2.0 2.1 2.2 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
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