[Federal Register Volume 87, Number 76 (Wednesday, April 20, 2022)]
[Rules and Regulations]
[Pages 23434-23441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08273]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 165

[Docket No. FDA-2018-N-1815]
RIN 0910-AI03


Beverages: Bottled Water

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final rule.

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SUMMARY: 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

[[Page 23435]]

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).

DATES: This rule is effective June 21, 2022. The compliance date is 
October 17, 2022.

ADDRESSES: 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, 
[email protected]; 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.

SUPPLEMENTARY INFORMATION:

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
II. Background
    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
    A. Introduction
    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
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. References

I. Executive Summary

A. Purpose of the Final Rule

    We are amending the allowable levels for fluoride in bottled water 
to which fluoride is added, to be consistent with the updated 
recommendation by the PHS on the optimal fluoride concentration in 
community water systems that add fluoride for the prevention of dental 
caries.

B. Summary of the Major Provisions of the Final Rule

    The final rule revises the quality standard for bottled water 
(found in Sec.  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.

C. Legal Authority

    This final rule updates the quality standard for bottled water, 
consistent with our authority in sections 401, 403, and 701(a) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 341, 343, 
and 371(a)). We discuss our legal authority in greater detail in 
section III.

D. Costs and Benefits

    This final rule revises the quality standard regulations so that 
the allowable level for fluoride is 0.7 mg/L in bottled water to which 
fluoride has been added, which is consistent with the current PHS 
recommendation on the optimal level of fluoride in community water 
systems that add fluoride for the prevention of dental caries. We 
estimate that there will be one-time costs to read and understand the 
rule for all bottled water manufacturers and one-time costs to verify 
the fluoride level after adjustment of the manufacturing process for 
bottled water manufacturers that choose to add fluoride to their 
product. The one-time costs range between $214,370.26 and $333,338.24. 
When discounted at 7 percent over 10 years, the annualized costs range 
from $30,521.50 to $47,459.87. When discounted at 3 percent over 10 
years the annualized costs range from $25,130.73 to $39,077.41.

II. Background

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 Sec.  
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

[[Page 23436]]

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 Sec.  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.

III. Legal Authority

    We are updating the quality standard establishing the allowable 
levels for fluoride in bottled water to which fluoride has been added, 
as set forth in this final rule, consistent with our authority in 
sections 401, 403, and 701(a) of the FD&C Act.
    Section 401 of the FD&C Act directs the Secretary of the Department 
of Health and Human Services (the Secretary) to issue regulations 
fixing and establishing for any food a reasonable definition and 
standard of identity, quality, or fill of container whenever in the 
judgment of the Secretary such action will promote honesty and fair 
dealing in the interest of consumers.
    Under section 403(h)(1) of the FD&C Act, a food is misbranded if it 
purports to be or is represented as a food for which a standard of 
quality has been prescribed by regulations under section 401 of the 
FD&C Act, and its quality falls below such standard, unless its label 
bears, in such manner and form as such regulations specify, a statement 
that it falls below such standard.
    Under section 701(a) of the FD&C Act, we may issue regulations for 
the efficient enforcement of the FD&C Act to ``effectuate a 
congressional objective expressed elsewhere in the Act'' (Association 
of American Physicians and Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204 
(D.D.C. 2002) (citing Pharm. Mfrs. Ass'n v. FDA, 484 F. Supp. 1179, 
1183 (D. Del. 1980)). Updating this allowable level for fluoride in 
bottled water to be consistent with the updated PHS recommendation 
would help effectuate the congressional objective expressed in sections 
401 and 403 of the FD&C Act.

IV. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received no comments on our proposal to remove references to 
annual averages of maximum daily air temperatures in Sec.  165.110(b) 
and are finalizing it without change. We received more than 90 comments 
on other provisions of the proposed rule, and each comment discussed 
one or more issues. The comments came from individuals, academia, 
healthcare professionals, consumer advocacy groups, research 
associations, and industry trade associations.
    We describe and respond to the comments in sections B through F of 
this section. We have numbered each comment to help distinguish between 
different comments. We have grouped similar comments together under the 
same number, and, in some cases, we have separated different issues 
discussed in the same comment and designated them as distinct comments 
for purposes of our responses. The number assigned to each comment or 
comment topic is purely for organizational purposes and does not 
signify the comment's value or importance or the order in which 
comments were received.

B. Description of General Comments and FDA Response

    Many comments made general remarks supporting or opposing the 
proposed rule without focusing on a particular proposed provision. In 
the following paragraphs, we discuss and respond to such general 
comments.
    (Comment 1) Many comments expressed general support for the 
proposed rule. A few comments stated that the proposed rule, if 
finalized, would provide consistency between domestically packaged and 
imported bottled water.
    (Response 1) We proposed to revise, and are revising, the allowable 
level for fluoride to 0.7 mg/L in bottled water to which fluoride has 
been added, a level consistent with the current PHS recommendations for 
the optimal level of fluoride in community water systems to prevent 
dental caries. The revised allowable level is consistent between 
domestically packaged and imported bottled water. As stated in the 2011 
Department of Health and Human Services (HHS) notice proposing the 
revised recommended fluoride concentration, available data suggest that 
a concentration of 0.7 mg/L provides an optimal balance between the 
prevention of dental caries and the risk of dental fluorosis (76 FR 
2383 at 2386). The PHS confirmed this in 2015 (80 FR 24936).
    (Comment 2) A few comments advocated the availability of both 
fluoridated and non-fluoridated bottled water so that consumers have 
choices. One comment stated that FDA should not ask all bottlers to 
fluoridate to the 2015 PHS recommended level of 0.7 mg/L. Another said 
that consumers have a right to be aware of the content of their 
drinking water, and so FDA should require manufacturers who add 
fluoride to their water to label the amount added.
    (Response 2) Our final rule revises the allowable level for 
fluoride to 0.7 mg/L for bottled water to which fluoride is added. 
Manufacturers are not required to fluoridate their water, or to 
fluoridate to a level of 0.7 mg/L. Instead, our regulations, at Sec.  
165.110(a)(1), provide that fluoride may be optionally added up to the 
allowable level.
    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).

[[Page 23437]]

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 Sec.  
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 Sec.  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).
    (Comment 3) Some comments stated that FDA should not rely on the 
PHS recommendation and FDA should provide its own scientific 
justification for the fluoride level in the proposed rule. A few others 
asked FDA to review studies published on the safety of fluoride and 
community water fluoridation after the 2015 PHS recommendation.
    (Response 3) We disagree with the comments stating that FDA should 
not rely on the PHS recommendation. In the preamble to the proposed 
rule, we explained the basis for the PHS's 2015 recommendation and 
concluded that the basis is a sound public health measure that should 
also apply to bottled water to which fluoride is added. Furthermore, 
the PHS recommended 0.7 mg/L fluoride after systematic reviews of 
existing science by a Federal interdepartmental, interagency panel of 
scientists, including scientists from FDA (76 FR 2383, January 13, 
2011; 80 FR 24936, May 1, 2015). This is consistent with our approach 
in 1973, when we established the allowable levels for fluoride in 
bottled water based on the PHS's 1962 Drinking Water Standards. At that 
time we also concluded that the addition of fluoride to bottled water 
should be permitted to be consistent with the policy of community water 
fluoridation (38 FR 32558 at 32561). We also believe this will help 
promote honesty and fair dealing in the interest of consumers under 
section 401 of the FD&C Act (21 U.S.C. 341) in that consumers may 
expect the levels of fluoride added to bottled water to be consistent 
with the levels of fluoride in public drinking water.
    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. The PHS recommendation has not changed, and we maintain 
that the addition of fluoride to bottled water should be permitted to 
be consistent with the policy of community water fluoridation. Given 
that the comments provided no new information indicating the need to 
duplicate the scientific evaluation already conducted by PHS, we are 
revising the allowable level for fluoride in bottled water to which 
fluoride is added based on the 2015 PHS recommendation.
    (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.
    (Response 4) As an initial matter, we consider fluoride to be a 
nutrient. As stated in our response to comment 3, the addition of 
fluoride to bottled water should be permitted to be consistent with the 
PHS recommended level of community water fluoridation, and the PHS 
recommendation is a sound public health measure that should also apply 
to bottled water to which fluoride is added. The PHS recommendation 
addressed the potential for dental fluorosis as well as concerns about 
other adverse effects from water fluoridation (80 FR 24936 at 24940 
through 24942). The PHS recommendation also addressed the concerns 
regarding the safety of fluoride additives (80 FR 24936 at 24942 
through 24943). The comments did not provide, and we are not aware of, 
evidence that fluoride added to bottled water up to 0.7 mg/L is a 
contaminant or poison, or that fluoride is an industrial waste product.
    Regarding the comments suggesting that this rule endorses or 
encourages bottled water fluoridation, we note in our response to 
comment 2 that the rule does not require manufacturers to fluoridate 
their water, or to fluoridate to a level of 0.7 mg/L. Instead, our 
regulations, at Sec.  165.110(a)(1), provide that fluoride may be 
optionally added up to the allowable level. We also note that we are 
not adopting or identifying an optimum fluoride level for bottled water 
to which fluoride has been added, and we maintain that the addition of 
fluoride to bottled water should be consistent with the policy of 
community water fluoridation.
    Regarding the ingestion of fluoride, we recognize that consumers 
are also exposed to fluoride from other sources. The PHS considered the 
availability of other fluoride-containing products, including 
toothpastes, mouth rinses, and professionally applied fluoride 
compounds, when establishing the 0.7 mg/L optimum level for community 
water fluoridation (80 FR 24936 at 24937 through 24938). The PHS also 
stated that community water fluoridation is a major factor responsible 
for the decline of the prevalence and severity of dental caries during 
the second half of the 20th century, and that, when analyses were 
limited to studies conducted after the introduction of other sources of 
fluoride, especially fluoride toothpaste, beneficial effects across the 
lifespan from community water fluoridation were still apparent (80 FR 
24936 at 24937).
    (Comment 5) One comment supported the proposal but asked whether 
the reduction of the amount of added fluoride in bottled water will 
have any other unforeseen long-term effects on the population.
    (Response 5) The comment did not provide, and we are not aware of, 
any information regarding unforeseen long-term effects on the 
population of a 0.7 mg/L fluoride limit in bottled water to which 
fluoride is added.

C. Comments on the Level of Added Fluoride in Bottled Water and FDA 
Response

    (Comment 6) Some comments that supported the proposed rule 
specifically supported the proposed level of 0.7 mg/L and stated that 
the level is consistent with public health

[[Page 23438]]

recommendations, FDA guidance, and current industry practice.
    (Response 6) As we noted in our response to comment 1, we proposed 
to revise the standard for the allowable level for fluoride to 0.7 mg/L 
in bottled water to which fluoride has been added, a level consistent 
with the updated PHS recommendations. As stated in the 2011 HHS notice 
proposing the revised recommended fluoride concentration, available 
data suggest that a fluoride concentration of 0.7 mg/L provides an 
optimal balance between the prevention of dental caries and the risk of 
dental fluorosis (76 FR 2383 at 2386). Moreover, 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, or different standards for 
domestically packaged and imported bottled water.
    (Comment 7) One comment said that there is no need for this rule 
because there is no immediate danger in the levels of fluoride in 
bottled water.
    (Response 7) We disagree that there is no need for this rule or 
that an ``immediate danger'' is needed to take this action. This final 
rule is consistent with our authority in sections 401, 403, and 701(a) 
of the FD&C Act. We have concluded that the basis for PHS' updated 
recommendation of optimum fluoridation level of 0.7 mg/L in community 
water is a sound public health measure that should also apply to 
bottled water.
    When we adopted the 1962 PHS drinking water standard for fluoride, 
we 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). In addition, this rule 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, or different 
standards for domestically packaged and imported bottled water.
    (Comment 8) Some comments asked FDA to regulate the level of 
fluoride naturally present in bottled water. A few comments 
specifically asked FDA to reduce the allowable levels for naturally 
occurring fluoride to 0.7 mg/L, and a few others indicated that FDA 
should not permit the sale of bottled water with natural fluoride 
concentrations above 0.7 mg/L.
    (Response 8) The regulation of bottled water to which no fluoride 
is added is outside the scope of this rule. Our regulations, at Sec.  
165.110(b)(4)(ii)(A) and (B), limit the amount of fluoride in domestic 
and imported bottled water to which no fluoride is added. Those levels 
range from 1.4 to 2.4 mg/L. Our current revision of the allowable 
levels of fluoride in bottled water is based on the 2015 PHS 
recommendation, which does not affect community water systems with 
naturally occurring fluoride in water at concentrations greater than 
0.7 mg/L (80 FR 24936 at 24937). Therefore, we are not revising the 
allowable levels for fluoride in bottled water to which fluoride has 
not been added by the manufacturer.
    We note that the maximum fluoride level we are finalizing limits 
the total amount of fluoride that may be present in bottled water to 
which fluoride is added--that is, the sum of added and naturally 
occurring fluoride amounts in bottled water to which fluoride is added 
may not exceed 0.7 mg/L.
    (Comment 9) Several comments expressed concern that even if the 
amount of added fluoride is safe, the final fluoride level in bottled 
water to which fluoride is added may be unsafe because either: (a) The 
water to which fluoride is added may already contain fluoride; or (b) 
ingestion of both fluoridated community water and bottled water to 
which fluoride is added would lead to fluoride overconsumption.
    (Response 9) As we noted in our response to comment 8, the maximum 
fluoride level we are finalizing limits the total amount of fluoride 
that may be present in bottled water to which fluoride is added--that 
is, the sum of added and naturally occurring fluoride amounts in 
bottled water to which fluoride is added may not exceed 0.7 mg/L. The 
regulation of bottled water to which no fluoride is added (which may 
contain naturally occurring fluoride) and of municipal water is outside 
the scope of this rule. However, the PHS considered the availability of 
other fluoride-containing products when establishing the 0.7 mg/L 
optimum level for community water fluoridation (80 FR 24936 at 24937).
    (Comment 10) One comment recommended a level of 0.6 mg/L and cited 
the recommendation from the New Hampshire Department of Environmental 
Services (NH DES) (Ref. 3).
    (Response 10) The NH DES recommends a drinking water fluoride level 
of 0.6 to 0.8 mg/L. It references the Centers for Disease Control and 
Prevention (CDC) community water fluoridation website (Ref. 4), which 
further references the 2015 U.S. PHS recommended level of 0.7 mg/L. As 
such, the NH DES's recommendation is consistent with the 2015 PHS 
recommendation. The comment did not provide other information to 
support the 0.6 mg/L level. Therefore, we are not revising the 
allowable level to 0.6 mg/L.
    (Comment 11) One comment asked FDA to create an acceptable range of 
fluoride for the purposes of compliance with the rule, because such a 
range would appropriately recognize that: (a) Adding fluoride to 
bottled water is not an exact process; and (b) existing FDA regulations 
require added minerals to be present at least at the level declared on 
the label. The comment stated that this type of operational flexibility 
is needed because the level of fluoride in a bottled water product with 
added fluoride will be subject to some variation, consistent with good 
manufacturing practices. The comment said that, if the proposed rule is 
finalized without the requested range for compliance, the rule would 
appear to create a paradox with respect to compliance with two sets of 
FDA regulations: (1) This rule, which establishes 0.7 mg/L as the 
maximum or ceiling for bottled water to which fluoride is added; and 
(2) the FDA compliance standard for nutrition labeling, which 
establishes the declared level as the minimum or floor by requiring a 
composite sample tested for an added mineral like fluoride to contain 
the mineral at least 100 percent of the declared level. The comment 
specifically asked FDA to establish a range of 0.6 to 1.0 mg/L for 
fluoride in bottled water intended for children 4 years and older and 
adults, and a separate range of 0.4 to 0.7 mg/L for fluoride in bottled 
water intended for infants and toddlers under 4 years of age.
    (Response 11) We decline to create a compliance range and are 
finalizing the revision of the standard for the allowable level for 
fluoride to 0.7 mg/L in bottled water to which fluoride has been added.
    We recognize that there are potential variabilities in adding 
fluoride in bottled water during manufacturing and variabilities during 
fluoride measurement. We also recognize that the CDC proposed an 
operational control range of 0.6 to 1.0 mg/L in community water systems 
that adjust fluoride (83 FR 32666, July 13, 2018). The proposed range 
is based on the ability of community water systems to stay successfully 
within a particular operational control range (83 FR 32666 at 32667). 
The comment did not provide information on fluoride variations within 
community water systems that are applicable to a bottled water 
manufacturing environment or to

[[Page 23439]]

support the requested compliance ranges. Additionally, we have no 
information, and received no comments, suggesting that some current 
single-level fluoride standards that have no compliance range (e.g., 
0.8 mg/L for bottled water to which fluoride is added and that is at an 
annual average of maximum daily air temperature between 79.3 to 90.5 
[deg]F) have posed unreasonable challenges to the bottled water 
industry.
    We agree that our regulations require added minerals to be present 
at least at the level declared on the label. Our regulations, at Sec.  
101.9(g)(4)(i), state that a food with a label declaration of, among 
other things, a mineral that meets our definition of a Class I nutrient 
is misbranded under section 403(a) of the FD&C Act unless its nutrient 
content is formulated to be at least equal to the value for that 
nutrient declared on the label. We explained in the Nutrition Facts 
Label final rule that we consider fluoride to be a nutrient, and 
specifically, a mineral (81 FR 33742 at 33883). Added fluoride is a 
Class I nutrient for nutrition labeling purposes because it is an added 
nutrient in fortified or fabricated foods (Sec.  101.9(g)(3)(i)).
    A label declaration is required if a claim about fluoride content 
is made on the label or in the labeling of foods (see Sec.  
101.9(c)(5)). Our regulations would require the fluoride levels in such 
products to be at least at the level declared on the label. That 
minimum fluoride level is not incompatible with the fluoride level 
finalized in this rule. We understand that, to account for process 
variability, industry may formulate to a slightly higher fluoride 
content to ensure the impacted products consistently meet the minimum 
requirement for nutrient declaration as described in Sec.  
101.9(g)(4)(i). We expect that the slight overage of fluoride used to 
account for process variability is small and would be consistent with 
current good manufacturing practice (Sec.  101.9(g)(6)). In addition, 
an FDA sample for nutrient analysis consists of a composite of 12 
subsamples (consumer units), with one sample taken from each of 12 
different randomly chosen shipping cases, to be representative of a lot 
(Sec.  101.9(g)(2)). FDA conducts nutrient analyses using appropriate 
methods as given in the Official Methods of Analysis of the AOAC 
International (id.). Therefore, our sampling procedure for compliance 
purposes already takes into account the sample variabilities within a 
lot. Furthermore, as discussed in our response to comment 2, bottled 
water manufacturers that fluoridate their water are not required to 
fluoridate to a level of 0.7 mg/L--lower levels are permitted. A 
bottled water manufacturer could target a fluoridation level below 0.7 
mg/L, and, even with the slight overage consistent with current good 
manufacturing practices, we would expect the finished product to be in 
compliance with both the labeling requirement in Sec.  101.9(g)(4)(i) 
and the allowable level for fluoride finalized in this rule.

D. Comment on the Health Effects of Added Fluoride and FDA Response

    (Comment 12) A few comments expressed concern that dental fluorosis 
could occur in infants who consume infant formula reconstituted with 
fluoridated bottled water.
    (Response 12) The PHS considered this when they issued their 2015 
recommendation. They stated that, if an infant is consuming only infant 
formula mixed with fluoridated water, there may be an increased chance 
for permanent teeth to have mild dental fluorosis (80 FR 24936 at 24940 
through 24941). To lessen this chance, parents may choose to use low-
fluoride bottled water some of the time to mix infant formula, e.g., 
bottled waters labeled as deionized, purified, demineralized, or 
distilled, and without any fluoride added after purification treatment 
(80 FR 24936 at 24940). However, the PHS concluded that their 
recommendation to lower the fluoride concentration for community water 
fluoridation should decrease fluoride exposure during the time of 
enamel formation, from birth through 8 years of age for most permanent 
teeth, and further lessen the chance for children's teeth to have 
dental fluorosis, while keeping the decay prevention benefits of 
fluoridated water (80 FR 24936). We expect the same balance between the 
prevention of dental caries and the risk of dental fluorosis from 
consumption of bottled water to which fluoride is added because this 
rule revises the allowable fluoride level in those products to be 
consistent with the 2015 PHS recommendation. The comments provided no 
new information on this topic, and we agree with PHS' analysis.
    As discussed in our response to comment 2, fluoride added to 
bottled water must be declared in the ingredient list in accordance 
with Sec.  101.4. Consumers can examine bottled water labeling to 
determine whether fluoride has been added by, for instance, noting the 
type of bottled water (e.g., purified) and reading the ingredient 
declaration (i.e., for whether fluoride is listed as an ingredient).

E. Comment on the Compliance Date and FDA Response

    (Comment 13) One comment expressed concern over bottled water 
manufactured prior to the effective date of the final rule. It asked 
whether these products can continue to be sold, and if these products 
would impact consumer health. The comment suggested FDA state publicly 
that bottled water produced under the current standard will not 
adversely influence consumers health so that the consumer can keep 
buying in the period between the effective date and the compliance 
date. The comment also stated that the proposed compliance date of 120 
days after the effective date is too tight for large companies, which 
may need a longer time to adjust all of their fluoridated water 
products.
    (Response 13) The comment provided, and we are aware of, no 
information suggesting that that there will be product remaining in 
inventories that does not comply with the rule after the compliance 
date, and that large companies may need a longer time to adjust their 
fluoridated products. We stated in the proposed rule that many bottled 
water manufacturers in the United States have already adjusted their 
addition of fluoride to obtain the 0.7 mg/L fluoride in their finished 
bottled water in response to the updated 2015 PHS recommendation and 
FDA's April 27, 2015, letter to manufacturers, distributors or 
importers of bottled water (84 FR 12975 at 12977). We received no 
comments from bottled water manufacturers or industry groups expressing 
concerns with inventory remaining after the compliance date. Therefore, 
we do not expect any significant amount of bottled water products to 
which fluoride has been added and whose fluoride are at levels above 
0.7 mg/L to remain in inventory after the compliance date. We are 
finalizing the effective and compliance dates as proposed. With regard 
to the comment's question about the impact on public health of bottled 
water manufactured prior to this rule's effective date that meets the 
previous quality standard for added fluoride, we do not have safety 
concerns. We note that any such bottled water would be misbranded if it 
did not comply with the label statement requirements under Sec.  
165.110(c).

F. Miscellaneous Comments and FDA Response

    Many comments addressed aspects of fluoride other than the 
allowable level in bottled water to which fluoride is added. Some 
aspects, such as allowable

[[Page 23440]]

fluoride levels in municipal water systems, the price of bottled water, 
and other substances that we could consider requiring or allowing in 
bottled water, are outside the scope of the rule, and we will not 
address them here.
    We discuss the other miscellaneous comments in the following 
paragraphs.
    (Comment 14) One comment said that too many children, especially 
infants, are ingesting too much fluoride. The comment said that the 
warning statement ``Do Not Use Fluoridated Water For Infants or Making 
Formula'' must be placed on fluoridated water, and the warning 
statement ``For Adult Use Only'' should be placed on fluoridated water.
    (Response 14) As discussed in our response to comment 2, fluoride 
added to bottled water must be declared in the ingredient list in 
accordance with Sec.  101.4. Consumers can examine bottled water 
labeling to determine whether fluoride has been added by, for instance, 
noting the type of bottled water (e.g., purified) and reading the 
ingredient declaration (i.e., for whether fluoride is listed as an 
ingredient). Parents may choose whether to give fluoridated bottled 
water to children and whether to use bottled water with added fluoride 
to mix infant formula. Additionally, as we explained in our response to 
comment 12, the level we are finalizing balances the prevention of 
dental caries and the risk of dental fluorosis from consumption of 
bottled water to which fluoride is added. The comment provided no new 
information on this topic. Therefore, we decline to revise the rule as 
suggested by the comment.
    (Comment 15) One comment asked whether the determination about 
Indian Tribal Governments in the proposed rule has changed.
    (Response 15) In the proposed rule, we tentatively concluded that 
the rule does not contain policies that would have a substantial direct 
effect on one or more Indian Tribes, on the relationship between the 
Federal Government and Indian Tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian Tribes. 
Our tentative conclusion has not changed. The comment did not provide 
any information that would cause us to reexamine or alter our tentative 
conclusion.

V. Effective/Compliance Dates

    Effective date: This rule is effective June 21, 2022.
    Compliance date: The compliance date of this final rule is October 
17, 2022.

VI. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). 
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.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because updating the standards of the allowable level for 
fluoride in bottled water to which fluoride has been added specified in 
this final rule will not significantly increase costs to bottled water 
manufacturers, we certify that the final rule will not have a 
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $158 
million, using the most current (2020) Implicit Price Deflator for the 
Gross Domestic Product. This final rule will not result in an 
expenditure in any year that meets or exceeds this amount.
    The rule revises the bottled water quality standard for the 
allowable level for fluoride to 0.7 mg/L in bottled water to which 
fluoride has been added, a level consistent with the updated PHS 
recommendations for the optimal level of fluoride in community water 
systems to prevent dental caries (tooth decay).
    There will be one-time costs to read and understand the rule for 
all bottled water manufacturers and one-time costs to verify the 
fluoride level after adjustment of the manufacturing process for 
bottled water manufacturers that choose to add fluoride to their 
product. The one-time costs range between $214,370.26 and $333,338.24. 
When discounted at 7 percent over 10 years, the annualized costs range 
from $30,521.50 to $47,459.87. When discounted at 3 percent over 10 
years the annualized costs range from $25,130.73 to $39,077.41.
    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. The full analysis of economic 
impacts is available in the docket for this final rule (Ref. 5) and at 
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.32(m) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

IX. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that this rule 
has federalism impacts as it amends the standard of quality regulations 
for bottled water. The existing standard of quality is not new and 
already preempts State laws because it is within the scope of section 
403A of the FD&C Act, an express preemption provision.

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects on one or 
more Indian Tribes, on the relationship between the Federal Government 
and Indian Tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive order and, consequently, a 
tribal summary impact statement is not required.

XI. References

    The following references are on display at the Dockets Management 
Staff (see ADDRESSES) and are available for

[[Page 23441]]

viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the 
date this document publishes in the Federal Register, but websites are 
subject to change over time.

1. FDA, ``Letter to Manufacturers, Distributors, or Importers of 
Bottled Water with an Update on Fluoride Added to Bottled Water'' 
(April 27, 2015). Available at https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/bottledwatercarbonatedsoftdrinks/ucm444373.htm (accessed March 29, 
2022).
2. International Bottled Water Association Communication to H. Kim, 
FDA, Letter, 6/15/2018.
3. New Hampshire Department of Environmental Services, Environmental 
Fact Sheet: Fluoride in Drinking Water (2020). Available at https://www.des.nh.gov/sites/g/files/ehbemt341/files/documents/2020-01/dwgb-3-5.pdf (accessed March 29, 2022).
4. Centers for Disease Control and Prevention, ``Community Water 
Fluoridation.'' Available at https://www.cdc.gov/fluoridation/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Ffluoridation%2Findex.htm (accessed March 29, 2022).
5. FDA, ``Final Rule to Revise the Allowable Level of Fluoride in 
Bottled Water to which Fluoride Has Been Added, Economic Analysis of 
Impacts, Regulatory Flexibility Analysis, Unfunded Mandates Reform 
Act Analysis.'' Available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (accessed 
March 29, 2022).

List of Subjects in 21 CFR Part 165

    Beverages, Bottled water, Food grades and standards.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
part 165 is amended as follows:

PART 165--BEVERAGES

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e.


0
2. Amend Sec.  165.110 by revising paragraphs (b)(4)(ii)(C) and (D) to 
read as follows:


Sec.  165.110   Bottled water.

* * * * *
    (b) * * *
    (4) * * *
    (ii) * * *
    (C) Bottled water packaged in the United States to which fluoride 
is added must not contain fluoride in excess of 0.7 milligram per 
liter.
    (D) Imported bottled water to which fluoride is added must not 
contain fluoride in excess of 0.7 milligram per liter.
* * * * *

    Dated: April 8, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-08273 Filed 4-19-22; 8:45 am]
BILLING CODE 4164-01-P


