{"abstract":"The Food and Drug Administration (FDA or we) is granting a color additive petition submitted by Center for Science in the Public Interest, et al., by repealing the color additive regulations that permit the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. The petitioners provided data demonstrating that this additive induces cancer in male rats. Therefore, FDA is revoking the authorized uses in food and ingested drugs of FD&C Red No. 3 in the color additive regulations.","action":"Final amendment; order.","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/2025/01/16/2025-00830.html","cfr_references":[{"chapter":null,"citation_url":null,"part":74,"title":21}],"citation":"90 FR 4628","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective January 15, 2027, except for amendatory instruction 4, which is effective January 18, 2028. If any provisions are delayed or stayed by the filing of proper objections, FDA will publish such notification in the Federal Register. Submit either electronic or written objections and requests for a hearing on the order by February 18, 2025. See section X for further information on the filing of objections.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-N-0437"],"dockets":[{"supporting_documents":[{"title":"Reference 7 - CTS84566_C_memo_no redactions needed","document_id":"FDA-2023-N-0437-34792"},{"title":"Reference 6 - CAP 3C0323_T_memo_final","document_id":"FDA-2023-N-0437-34791"},{"title":"Reference 5 - CAC Red 3 Memo Signed 10 30 19","document_id":"FDA-2023-N-0437-34790"},{"title":"Reference 4 - JECFA Safety Evaluation of Certain Food Additives 86th Report 2020 COPYRIGHT","document_id":"FDA-2023-N-0437-34789"},{"title":"Reference 3 - JECFA Evaluation of Certain Food Additives and Contaminants 37th Report 1991 COPYRIGHT","document_id":"FDA-2023-N-0437-34788"},{"title":"Reference 2 - SCF Reports of the Scientific Committee for Food 21st series 1989 COPYRIGHT","document_id":"FDA-2023-N-0437-34787"},{"title":"Reference 1 - CAP3C0323_Reg memo_07012024_Revised Final_signed","document_id":"FDA-2023-N-0437-34786"},{"title":"References and Supporting and Related Material List for FDA-2023-N-0437","document_id":"FDA-2023-N-0437-34785"}],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2025-01-16","updated_at":"2025-02-21T00:55:58.920-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-0437-34784","allow_late_comments":false,"id":"FDA-2023-N-0437-34784","comment_end_date":"2025-02-19","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":8,"id":"FDA-2023-N-0437","title":"Filing of Color Additive Petition from Center for Science in the Public Interest, et al.; Request to Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs."}],"document_number":"2025-00830","effective_on":"2027-01-15","end_page":4634,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/01/16/2025-00830.xml","html_url":"https://www.federalregister.gov/documents/2025/01/16/2025-00830/color-additive-petition-from-center-for-science-in-the-public-interest-et-al-request-to-revoke-color","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-00830?publication_date=2025-01-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-01-16/2025-00830/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":12675,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-16/pdf/2025-00830.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-00830.pdf?1736948729","publication_date":"2025-01-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/01/16/2025-00830.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 7 - CTS84566_C_memo_no redactions needed","document_id":"FDA-2023-N-0437-34792"},{"title":"Reference 6 - CAP 3C0323_T_memo_final","document_id":"FDA-2023-N-0437-34791"},{"title":"Reference 5 - CAC Red 3 Memo Signed 10 30 19","document_id":"FDA-2023-N-0437-34790"},{"title":"Reference 4 - JECFA Safety Evaluation of Certain Food Additives 86th Report 2020 COPYRIGHT","document_id":"FDA-2023-N-0437-34789"},{"title":"Reference 3 - JECFA Evaluation of Certain Food Additives and Contaminants 37th Report 1991 COPYRIGHT","document_id":"FDA-2023-N-0437-34788"},{"title":"Reference 2 - SCF Reports of the Scientific Committee for Food 21st series 1989 COPYRIGHT","document_id":"FDA-2023-N-0437-34787"},{"title":"Reference 1 - CAP3C0323_Reg memo_07012024_Revised Final_signed","document_id":"FDA-2023-N-0437-34786"},{"title":"References and Supporting and Related Material List for FDA-2023-N-0437","document_id":"FDA-2023-N-0437-34785"}],"comments_count":1,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2023-N-0437","supporting_documents_count":8,"docket_id":"FDA-2023-N-0437","document_id":"FDA-2023-N-0437-34784","regulation_id_number":null,"title":"Filing of Color Additive Petition from Center for Science in the Public Interest, et al.; Request to Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs.","checked_regulationsdotgov_at":"2025-02-22T01:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":4628,"subtype":null,"title":"Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs","toc_doc":"Color Additive; Center for Science in the Public Interest, et al.; Request to Revoke Color Additive Listing for Use of FD and C Red No. 3 in Food and Ingested Drugs","toc_subject":"Petition","topics":["Color additives","Cosmetics","Drugs"],"type":"Rule","volume":90}