{"abstract":"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).","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2022/04/20/2022-08273.html","cfr_references":[{"chapter":null,"citation_url":null,"part":165,"title":21}],"citation":"87 FR 23434","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective June 21, 2022. The compliance date is October 17, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-1815"],"dockets":[],"document_number":"2022-08273","effective_on":"2022-06-21","end_page":23441,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/04/20/2022-08273.xml","html_url":"https://www.federalregister.gov/documents/2022/04/20/2022-08273/beverages-bottled-water","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-08273?publication_date=2022-04-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-04-20/2022-08273/mods.xml","not_received_for_publication":null,"page_length":8,"page_views":{"count":5681,"last_updated":"2026-04-05 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-04-20/pdf/2022-08273.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-08273.pdf?1650372313","publication_date":"2022-04-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/04/20/2022-08273.txt","regulation_id_number_info":{"0910-AI03":{"issue":"202110","html_url":"https://www.federalregister.gov/regulations/0910-AI03/beverages-bottled-water","title":"Beverages: Bottled Water","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202110&RIN=0910-AI03&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AI03"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Tab C - FDA - Fluoride Bottled Water - FRIA (2021-253) as cleared OMB (version 2-14-22)","document_id":"FDA-2018-N-1815-0108"},{"title":"Tab C - FDA - FluorideBottledWater - FINAL RULE (2021-253) as cleared OMB (version 4-1-2022)","document_id":"FDA-2018-N-1815-0107"},{"title":"Tab B - Fluoride Bottled Water - FRIA (2021-253) comparision OMB original to final","document_id":"FDA-2018-N-1815-0106"},{"title":"Tab B - Fluoride Bottled Water - Final Rule (2021-253) comparison OMB original to final","document_id":"FDA-2018-N-1815-0105"},{"title":"Tab A - (2021-253) FluorideBottledWater - FRIA - as submitted to OMB (1-7-22 version)","document_id":"FDA-2018-N-1815-0104"},{"title":"Tab A - (2021-253) FluorideBottledWater- Final Rule - as submitted to OMB (1-7-22 version)","document_id":"FDA-2018-N-1815-0103"},{"title":"Memorandum to FDA DMS on Bottled Water Final Rule (DocketNo.FDA-2018-N-1815)","document_id":"FDA-2018-N-1815-0102"},{"title":"Reference 5 - FDA - Fluoride Bottled Water - FRIA 2021-253 final RE Beverages: Bottled Water","document_id":"FDA-2018-N-1815-0101"},{"title":"Reference 4 - Community Water Fluoridation Division of Oral Health  CDC RE Beverages: Bottled Water","document_id":"FDA-2018-N-1815-0100"},{"title":"Reference 3 - NHDES Fact Sheet 2020 RE Beverages: Bottled Water","document_id":"FDA-2018-N-1815-0099"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-1815","supporting_documents_count":16,"docket_id":"FDA-2018-N-1815","document_id":"FDA-2018-N-1815-0096","regulation_id_number":null,"title":"Beverages: Bottled Water","checked_regulationsdotgov_at":"2022-04-21T03:30:05Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":23434,"subtype":null,"title":"Beverages: Bottled Water","toc_doc":"Bottled Water","toc_subject":"Beverages:\n","topics":["Beverages","Beverages","Food grades and standards"],"type":"Rule","volume":87}