{"abstract":"The Food and Drug Administration (FDA) is issuing this final rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The final rule describes the process and statutory criteria for requesting an exemption and explains how FDA reviews requests for exemptions. This regulation satisfies the requirement in the Tobacco Control Act that FDA issue regulations implementing the exemption provision.","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/2011/07/05/2011-16766.html","cfr_references":[{"chapter":null,"citation_url":null,"part":16,"title":21},{"chapter":null,"citation_url":null,"part":1107,"title":21}],"citation":"76 FR 38961","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective August 4, 2011.","disposition_notes":null,"docket_ids":["Docket No. FDA-2010-N-0646"],"dockets":[],"document_number":"2011-16766","effective_on":"2011-08-04","end_page":38975,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/07/05/2011-16766.xml","html_url":"https://www.federalregister.gov/documents/2011/07/05/2011-16766/tobacco-products-exemptions-from-substantial-equivalence-requirements","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-16766?publication_date=2011-07-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-07-05/2011-16766/mods.xml","not_received_for_publication":null,"page_length":15,"page_views":{"count":5054,"last_updated":"2026-07-26 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-07-05/pdf/2011-16766.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-07-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/07/05/2011-16766.txt","regulation_id_number_info":{"0910-AG39":{"issue":"201104","html_url":"https://www.federalregister.gov/regulations/0910-AG39/tobacco-product-substantial-equivalence-exemptions","title":"Tobacco Product Substantial Equivalence Exemptions","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201104&RIN=0910-AG39&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AG39"],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-07-23T10:09:48Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":38961,"subtype":null,"title":"Tobacco Products, Exemptions From Substantial Equivalence Requirements","toc_doc":"Exemptions From Substantial Equivalence Requirements","toc_subject":"Tobacco Products:","topics":["Administrative practice and procedure"],"type":"Rule","volume":76}