{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing conforming changes to its guidances issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as required by the Consolidated Appropriations Act of 2022, which amended the term \"tobacco product\" in the FD&C Act to include products that contain nicotine from any source.","action":"Notice.","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/2023/03/20/2023-03951.html","cfr_references":[],"citation":"88 FR 16636","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-3261-0001","comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Conforming changes to reflect the changes to FDA's guidance are made beginning March 20, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-N-3261"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-03-20","updated_at":"2024-11-06T21:46:28.481-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-3261-0001","allow_late_comments":true,"id":"FDA-2022-N-3261-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-N-3261","title":"Statutory Amendments to the Definition of the Term “Tobacco Product” in Guidances Issued Under the Federal Food, Drug, and Cosmetic Act."}],"document_number":"2023-03951","effective_on":null,"end_page":16639,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/03/20/2023-03951.xml","html_url":"https://www.federalregister.gov/documents/2023/03/20/2023-03951/definition-of-the-term-tobacco-product-in-guidances-issued-under-the-federal-food-drug-and-cosmetic","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-03951?publication_date=2023-03-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-03-20/2023-03951/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":642,"last_updated":"2026-10-22 16:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-03-20/pdf/2023-03951.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-03951.pdf?1679057115","publication_date":"2023-03-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/03/20/2023-03951.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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-2022-N-3261","supporting_documents_count":0,"docket_id":"FDA-2022-N-3261","document_id":"FDA-2022-N-3261-0001","regulation_id_number":null,"title":"Statutory Amendments to the Definition of the Term “Tobacco Product” in Guidances Issued Under the Federal Food, Drug, and Cosmetic Act.","checked_regulationsdotgov_at":"2024-11-08T00:00:12Z"},"regulations_dot_gov_url":"https://www.regulations.gov/commenton/FDA-2022-N-3261-0001","significant":null,"signing_date":null,"start_page":16636,"subtype":null,"title":"Definition of the Term “Tobacco Product” in Guidances Issued Under the Federal Food, Drug, and Cosmetic Act","toc_doc":"Definition of the Term \"Tobacco Product\" in Guidances Issued under the Federal Food, Drug, and Cosmetic Act","toc_subject":null,"topics":[],"type":"Notice","volume":88}