Note from Fluoride Action Network:
• The Final Rule is online here, and the PDF is here.
• FAN’s submission to FDA is here. FDA in its Final Rule did not respond to the issue we raised.
• 92 people made comments – read them at https://www.regulations.gov/
• The docket for this Final Rule is at FDA-2018-N-1815
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).
This rule is effective June 21, 2022. The compliance date is October 17, 2022.
For access to the docket to read background documents or comments received, go to https://www.regulations.gov and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT:
David Whitman, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-3754, David.Whitman@fda.hhs.gov ; or Deirdre Jurand, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy (HFS-024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
A. Need for the Regulation/History of This Rulemaking
B. Summary of Comments to the Proposed Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
B. Description of General Comments and FDA Response
C. Comments on the Level of Added Fluoride in Bottled Water and FDA Response
D. Comment on the Health Effects of Added Fluoride and FDA Response
E. Comment on the Compliance Date and FDA Response
F. Miscellaneous Comments and FDA Response
V. Effective/Compliance Dates
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
X. Consultation and Coordination With Indian Tribal Governments
A. Need for the Regulation/History of This Rulemaking
In 1973, FDA established standards of quality for bottled water, including allowable levels for fluoride, based on the PHS’ 1962 Drinking Water Standards (38 FR 32558, November 26, 1973). In adopting the 1962 PHS drinking water standard for fluoride, FDA concluded that the addition of fluoride to bottled water should be permitted to be consistent with the policy of allowing community water fluoridation (38 FR 32558 at 32561). For bottled water to which fluoride is added that is packaged in the United States, FDA established as the allowable level a range (0.8 to 1.7 mg/L) based on the annual average maximum daily air temperatures at the location where the bottled water is sold at retail. For imported bottled water, we established a single allowable level for fluoride in bottled water to which fluoride is added (0.8 mg/L).
In 2015, the PHS updated and replaced its 1962 Drinking Water Standards related to community water fluoridation and recommended an optimal fluoride concentration of 0.7 mg/L. This recommendation is published in a Federal Register notice entitled “Public Health Service Recommendation for Fluoride Concentration in Drinking Water for Prevention of Dental Caries” (80 FR 24936, May 1, 2015). The same year, we issued a letter to industry recommending, based on the updated PHS recommendation, that bottled water manufacturers not add fluoride to bottled water at concentrations greater than a final concentration of 0.7 mg/L (Ref. 1). In our letter, we also stated our intent to revise the allowable levels for fluoride in bottled water to which fluoride has been added to be consistent with the updated PHS recommendation. We did not receive any objections to the letter, and bottled water manufacturer input indicates that most bottled water to which fluoride has been added that is sold or offered for sale in the United States, whether domestic or imported, now has no more than 0.7 mg/L fluoride (Ref. 2).
In the Federal Register of April 3, 2019, we issued a proposed rule to amend the quality standard for bottled water (found in §?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 (84 FR 12975) (“proposed rule”). We explained the basis for the PHS’s 2015 optimal fluoride concentration recommendation for drinking water, concluded that the basis is a sound public health measure that should also apply to bottled water, and noted that amending the allowable level for fluoride in bottled water to which fluoride had been added to 0.7 mg/L would be consistent with the updated PHS fluoride recommendation. We also stated that this may reduce any unnecessary confusion on the part of consumers from having the standard for fluoride added to bottled water differ from the PHS recommendations for community water fluoridation (84 FR 12975 at 12978).
In addition, consistent with the updated PHS recommendation, we proposed to remove references to annual averages of maximum daily air temperatures in §??165.110(b) because, as discussed in the updated PHS recommendation, data do not show a convincing relationship between fluid intake and ambient air temperature (84 FR 12975 at 12977).
We also proposed that the final rule be effective 60 days after the date of the final rule’s publication in the Federal Register and a compliance date 120 days after the effective date.
B. Summary of Comments to the Proposed Rule
The proposed rule provided a 60-day comment period. We received more than 90 comments. The comments came from individuals, academia, healthcare professionals, consumer advocacy groups, research associations, and industry trade associations. Among other things, the comments discussed:
• The level of added fluoride that should be in bottled water. Many comments supported our proposed level, but some opposed the addition of any fluoride to bottled water or supported an amount less than 0.7 mg/L. Additionally, some comments suggested that consumers should be able to choose between bottled water with and without added fluoride. Other comments suggested that we should do our own studies or consider additional research.
• The health effects of added fluoride to water. While some comments agreed that the proposed level would help prevent dental caries, some other comments expressed concern that the ingestion of fluoride could have adverse health effects, such as dental fluorosis, skeletal fluorosis, neurological toxicity, endocrine disruption, and lower IQ.
Consumers can examine bottled water labeling to determine whether fluoride has been added. In the preamble to the 1995 final rule establishing the standard of identity and standard of quality for bottled water, we explained that bottled water with added fluoride would be a multi-ingredient food and, as such, its label must bear ingredient labeling (60 FR 57076 at 57079, November 13, 1995). If fluoride is added to bottled water, it must be declared in the ingredients list (21 CFR 101.4(a)(1)). In addition, the terms “fluoridated,” “fluoride added,” or “with added fluoride” may be used on the label or in labeling of bottled water that contains added fluoride (21 CFR 101.13(q)(8)).
Finally, our regulations, at §?101.9(c)(5) (21 CFR 101.9(c)(5)), require the label declaration of fluoride in certain circumstances and allow for it voluntarily in all other cases.
While labeling the amount of fluoride added to bottled water is outside the scope of this rule, we note that mandatory declaration of the amount of fluoride is required if a claim about fluoride content is made on the label or in the labeling of foods (see §??101.9(c)(5)). We also addressed this in the preamble to our 2016 final rule entitled “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (81 FR 33742, May 27, 2016) (Nutrition Facts Label final rule). We declined to require the declaration of fluoride because, among other reasons, fluoride is a nonessential nutrient, a daily reference intake cannot be established based on available quantitative intake recommendations, and total fluoride intake can come from sources other than bottled water (81 FR 33742 at 33881).
We recognize that additional studies on the safety of fluoride have published since the publication of the 2015 PHS recommendation. We do not believe these studies contradict the PHS recommendation, and neither these studies nor the body of literature we have reviewed show adverse health effects of fluoride in humans up to the level we are finalizing.
(Comment 4) Some comments opposed the addition of any fluoride to bottled water. A few stated that fluoride is a contaminant, poison, or an industrial waste product, and suggested that our adoption of an optimal fluoride concentration, or use of the term “optimal,” is an endorsement of fluoridation or encourages the fluoridation of bottled water. Some comments listed possible adverse health effects of water fluoridation, such as dental fluorosis, skeletal fluorosis, neurological toxicity, endocrine disruption, and lower IQ. Some stated that the prevention of dental caries by ingesting fluoride does not have adequate scientific support and topical application of fluoride through toothpaste or mouthwash, or by a dentist, is a better way to prevent dental caries.