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HHS/FDA RIN: 0910-AI03 Publication ID: Fall 2021 
Title: Beverages: Bottled Water 

The final rule revises the quality standard regulations for the allowable level of fluoride in bottled water to which fluoride is added, to make these regulations consistent with an updated 2015 recommendation by the United States Public Health Service (PHS) for optimal fluoride concentration in community water systems. The final rule will not affect the allowable levels of fluoride in bottled water to which fluoride is not added, but which may contain fluoride from its source water.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 165.110   
Legal Authority: 21 U.S.C. 341    21 U.S.C. 343    21 U.S.C. 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  04/03/2019  84 FR 12975   
NPRM Comment Period End  06/03/2019 
Final Rule  03/00/2022 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Local, State 
Small Entities Affected: No  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
David Whitman
Supervisory Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
5001 Campus Drive, HFS-317,
College Park, MD 20740
Phone:240 402-3752