{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to establish new cigarette health warnings for cigarette packages and advertisements. The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning label statements. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) of 1965 to require each cigarette package and advertisement to bear one of the new required warnings. The final rule specifies the 11 new textual warning label statements and accompanying color graphics. FDA is taking this action to promote greater public understanding of the negative health consequences of cigarette smoking.","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/2020/03/18/2020-05223.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"1141","title":21}],"citation":"85 FR 15638","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective June 18, 2021. The incorporation by reference of a certain publication listed in the rule is approved by the Director of the Federal Register as of June 18, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-3065"],"dockets":[],"document_number":"2020-05223","effective_on":"2021-06-18","end_page":15710,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/03/18/2020-05223.xml","html_url":"https://www.federalregister.gov/documents/2020/03/18/2020-05223/tobacco-products-required-warnings-for-cigarette-packages-and-advertisements","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-05223?publication_date=2020-03-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-03-18/2020-05223/mods.xml","not_received_for_publication":null,"page_length":73,"page_views":{"count":26670,"last_updated":"2026-07-27 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-03-18/pdf/2020-05223.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-05223.pdf?1584449132","publication_date":"2020-03-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/03/18/2020-05223.txt","regulation_id_number_info":{"0910-AI39":{"issue":"201910","html_url":"https://www.federalregister.gov/regulations/0910-AI39/required-warnings-for-cigarette-packages-and-advertisements","title":"Required Warnings for Cigarette Packages and Advertisements","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201910&RIN=0910-AI39&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"}},"regulation_id_numbers":["0910-AI39"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 181 - Effects of Cigarette Smoking on Erectile Dysfunction, 2015","document_id":"FDA-2019-N-3065-0776"},{"title":"Reference 170 - Women and Smoking  - A Report of the Surgeon General, 2001","document_id":"FDA-2019-N-3065-0765"},{"title":"Reference 169 - COPD Guidelines - A Review of the 2018 GOLD Report, 2018","document_id":"FDA-2019-N-3065-0764"},{"title":"Reference 118 - Advancing Tobacco Product Warning Labels Research Methods and Theory, 2019","document_id":"FDA-2019-N-3065-0713"},{"title":"Reference 116 - Know Your Risk for Heart Disease, 2019","document_id":"FDA-2019-N-3065-0711"},{"title":"Reference 110 - Fundamentals of Estimating Sample Size, 2016","document_id":"FDA-2019-N-3065-0705"},{"title":"Reference 108 - How Many Do I Need - Basic Principles of Sample Size Estimation, 2004","document_id":"FDA-2019-N-3065-0703"},{"title":"Reference 96 - Perceived Effectiveness of Pictorial Health Warnings Among Mexican Youth and Adults, 2012","document_id":"FDA-2019-N-3065-0691"},{"title":"Reference 80 - The Visual Communication of Risk, 1999","document_id":"FDA-2019-N-3065-0675"},{"title":"Reference 73 - Three Steps Toward a Theory of Motivated Political Reasoning, 2000","document_id":"FDA-2019-N-3065-0668"}],"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-2019-N-3065","supporting_documents_count":566,"docket_id":"FDA-2019-N-3065","document_id":"FDA-2019-N-3065-0594","regulation_id_number":null,"title":"Tobacco Products; Required Warnings for Cigarette Packages and Advertisements","checked_regulationsdotgov_at":"2022-06-02T03:30:05Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":15638,"subtype":null,"title":"Tobacco Products; Required Warnings for Cigarette Packages and Advertisements","toc_doc":null,"toc_subject":null,"topics":["Advertising","Incorporation by reference","Labeling","Packaging and containers","Smoking","Tobacco"],"type":"Rule","volume":85}