{"abstract":"The Food and Drug Administration (FDA, the Agency, us, or we) is issuing a final rule that sets forth requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The rule will help ensure that PMTAs contain sufficient information for FDA to determine whether a marketing granted order should be issued for a new tobacco product. The rule codifies the general procedures FDA will follow when evaluating PMTAs and creates postmarket reporting requirements for applicants that receive marketing granted orders. The rule also requires tobacco product manufacturers to keep records establishing that their tobacco products are legally marketed, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.","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/2021/10/05/2021-21011.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1100,"title":21},{"chapter":null,"citation_url":null,"part":1107,"title":21},{"chapter":null,"citation_url":null,"part":1114,"title":21}],"citation":"86 FR 55300","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective November 4, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-2854"],"dockets":[],"document_number":"2021-21011","effective_on":"2021-11-04","end_page":55439,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/10/05/2021-21011.xml","html_url":"https://www.federalregister.gov/documents/2021/10/05/2021-21011/premarket-tobacco-product-applications-and-recordkeeping-requirements","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-21011?publication_date=2021-10-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-10-05/2021-21011/mods.xml","not_received_for_publication":null,"page_length":140,"page_views":{"count":35848,"last_updated":"2026-04-04 04:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-10-05/pdf/2021-21011.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-21011.pdf?1633351525","publication_date":"2021-10-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/10/05/2021-21011.txt","regulation_id_number_info":{"0910-AH44":{"issue":"202104","html_url":"https://www.federalregister.gov/regulations/0910-AH44/premarket-tobacco-product-applications-and-recordkeeping-requirements-","title":"Premarket Tobacco Product Applications and Recordkeeping Requirements ","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202104&RIN=0910-AH44&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AH44"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Memorandum to FDA DMS on PMTA Final Rule (Docket No. FDA-2019-N-2854) re: Premarket Tobacco Product Applications and Recordkeeping Requirements","document_id":"FDA-2019-N-2854-1148"},{"title":"Memorandum to FDA DMS on PMTA NPRM (Docket No. FDA-2019-N-2854)","document_id":"FDA-2019-N-2854-0664"},{"title":"PRIA Reference 4 - Deeming Tobacco Products - Final Regulatory Impact Analysis, 2016","document_id":"FDA-2019-N-2854-0125"},{"title":"PRIA Reference 1 - Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act Final Rule,2016","document_id":"FDA-2019-N-2854-0122"},{"title":"Reference 106 - Nicotine Levels and Presence of Selected Tobacco-Derived Toxins in Tobacco Flavoured, 2015","document_id":"FDA-2019-N-2854-0117"},{"title":"Reference 95 - pH Changes in Smokeless Tobaccos Undergoing Nitrosation During Prolonged Storage, 1993","document_id":"FDA-2019-N-2854-0101"},{"title":"Reference 98 - Microbial Community Structure and Dynamics of Dark Fire-Cured Tobacco Fermentation, 2007","document_id":"FDA-2019-N-2854-0100"},{"title":"Reference 85 - The Role of Oral Controlled Release Matrix Tablets in Drug Delivery Systems, 2012","document_id":"FDA-2019-N-2854-0094"},{"title":"Reference 89 - Characteristics and Toxicant Emissions of JUUL electronic cigarettes, 2019","document_id":"FDA-2019-N-2854-0090"},{"title":"Reference 91 - A Literature Review of Aging and Fermentation of Tobacco, 1964","document_id":"FDA-2019-N-2854-0088"}],"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-2854","supporting_documents_count":150,"docket_id":"FDA-2019-N-2854","document_id":"FDA-2019-N-2854-1147","regulation_id_number":null,"title":"Premarket Tobacco Product Applications and Recordkeeping Requirements","checked_regulationsdotgov_at":"2021-10-06T03:30:11Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":55300,"subtype":null,"title":"Premarket Tobacco Product Applications and Recordkeeping Requirements","toc_doc":"Premarket Tobacco Product Applications and Recordkeeping Requirements","toc_subject":null,"topics":["Administrative practice and procedure","Smoking","Tobacco","Tobacco"],"type":"Rule","volume":86}