{"abstract":"The Food and Drug Administration (FDA or we) is responding to objections and a public hearing request that we received from Combe Inc., on the final rule entitled \"Termination of Listing of Color Additives Exempt From Certification; Lead Acetate,\" which published on October 31, 2018. The final rule amended the color additive regulations to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp. After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. Therefore, the stay of the effectiveness for the repeal and delisting of the color additive regulation is now lifted, and we are amending the color additive regulations to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp.","action":"Final rule; response to objections and denial of public hearing requests; removal of administrative stay.","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/2021/10/08/2021-21892.html","cfr_references":[{"chapter":null,"citation_url":null,"part":73,"title":21}],"citation":"86 FR 56183","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective January 6, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-C-1951"],"dockets":[],"document_number":"2021-21892","effective_on":"2022-01-06","end_page":56195,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/10/08/2021-21892.xml","html_url":"https://www.federalregister.gov/documents/2021/10/08/2021-21892/termination-of-listing-of-color-additives-exempt-from-certification-lead-acetate","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-21892?publication_date=2021-10-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-10-08/2021-21892/mods.xml","not_received_for_publication":null,"page_length":13,"page_views":{"count":2807,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-10-08/pdf/2021-21892.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-21892.pdf?1633610721","publication_date":"2021-10-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/10/08/2021-21892.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 13 RE: Termination of Listing of Color\nAdditives Exempt From Certification;\nLead Acetate","document_id":"FDA-2017-C-1951-0240"},{"title":"Attachment 11-1 RE: Termination of Listing of Color\nAdditives Exempt From Certification;\nLead Acetate","document_id":"FDA-2017-C-1951-0239"},{"title":"Attachment 11 RE: Termination of Listing of Color\nAdditives Exempt From Certification;\nLead Acetate","document_id":"FDA-2017-C-1951-0238"},{"title":"Attachment 10 RE: Termination of Listing of Color\nAdditives Exempt From Certification;\nLead Acetate","document_id":"FDA-2017-C-1951-0237"},{"title":"Attachment 9 re: Termination of Listing of Color\nAdditives Exempt From Certification;\nLead Acetate","document_id":"FDA-2017-C-1951-0236"},{"title":"06) FDA-2017-C-1951-Fourth National Report on Human Exposure to Environmental Chemicals_Volume1_Mar2018","document_id":"FDA-2017-C-1951-0229"},{"title":"05) FDA-2017-C-1951-NTP Monograph on Health Effects of Low-Level Lead","document_id":"FDA-2017-C-1951-0228"},{"title":"04) FDA-2017-C-1951-ATSDR Tox Profile for Lead","document_id":"FDA-2017-C-1951-0227"},{"title":"03) FDA-2017-C-1951-Lead Acetate Chemistry Memorandum_Redacted","document_id":"FDA-2017-C-1951-0226"},{"title":"02) FDA-2017-C-1951-Lead Acetate Toxicology review Memorandum_Redacted","document_id":"FDA-2017-C-1951-0225"}],"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-2017-C-1951","supporting_documents_count":11,"docket_id":"FDA-2017-C-1951","document_id":"FDA-2017-C-1951-0235","regulation_id_number":null,"title":"Environmental Defense Fund, Earthjustice, Environmental Working Group,  Center for Environmental Health, Healthy Homes Collaborative, Health Justice Project of Loyola University Chicago School of Law, Breast Cancer Fund, Improving Kids’ Environment, Consumers Union, Natural Resources Defense Council, Consumer Federation of America, Learning Disabilities Association, Maricel Maffini,","checked_regulationsdotgov_at":"2021-10-09T03:30:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":56183,"subtype":null,"title":"Termination of Listing of Color Additives Exempt From Certification; Lead Acetate","toc_doc":"Lead Acetate","toc_subject":"Termination of Listing of Color Additives Exempt From Certification:\n","topics":["Color additives","Cosmetics","Drugs","Foods","Medical devices"],"type":"Rule","volume":86}