{"abstract":"The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.","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/2017/01/09/2016-31950.html","cfr_references":[{"chapter":null,"citation_url":null,"part":201,"title":21},{"chapter":null,"citation_url":null,"part":801,"title":21},{"chapter":null,"citation_url":null,"part":1100,"title":21}],"citation":"82 FR 2193","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective February 8, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-2002"],"dockets":[],"document_number":"2016-31950","effective_on":"2017-02-08","end_page":2217,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/01/09/2016-31950.xml","html_url":"https://www.federalregister.gov/documents/2017/01/09/2016-31950/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-31950?publication_date=2017-01-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-01-09/2016-31950/mods.xml","not_received_for_publication":null,"page_length":25,"page_views":{"count":31274,"last_updated":"2026-04-24 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-01-09/pdf/2016-31950.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-31950.pdf?1483710330","publication_date":"2017-01-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/01/09/2016-31950.txt","regulation_id_number_info":{"0910-AH19":{"issue":"201610","html_url":"https://www.federalregister.gov/regulations/0910-AH19/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-or-devices-","title":"Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs or Devices ","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201610&RIN=0910-AH19&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AH19"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"REFERENCE 10 - Eguale, T., D.L. Buckeridge, A. Verma, et al RE Regulations Regarding Intended Uses","document_id":"FDA-2015-N-2002-2034"},{"title":"REFERENCE 3 -  Citizen Petition from the Medical Information Working Group at 18 RE Regulations Regarding Intended Uses","document_id":"FDA-2015-N-2002-2033"},{"title":"REFERENCE 2 -  Complaint at 35–37, Par Pharmaceutical Inc. v. United States RE Regulations Regarding Intended Uses","document_id":"FDA-2015-N-2002-2032"},{"title":"REFERENCE 1 - Plaintiff’s Memorandum of Law at 38–40, Allergan Inc. v. United States RE Regulations Regarding Intended Uses","document_id":"FDA-2015-N-2002-2031"},{"title":"Reference 7 DOJ_Atlanta Man Convicted of Illegally Importing and Distributing Male Enhancement Products from China re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products","document_id":"FDA-2015-N-2002-1987"},{"title":"Reference 4 United States v. Bowen, 14-cr-00169-PAB, Indictment (D. Colo. May 5, 2014) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products","document_id":"FDA-2015-N-2002-1984"},{"title":"Reference 3 United States v. Carlson, 12-cr-00305-DSD-LIB, Court’s Instructions to the Jury, (D. Minn. Oct. 8, 2013) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products","document_id":"FDA-2015-N-2002-1983"},{"title":"Reference 1 United States v. LA Rush, 213-cr-00249, First Superseding Information (C.D. Cal. April 3, 2014) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products","document_id":"FDA-2015-N-2002-1981"},{"title":"TAB C 2016-308 Jurisdiction RIA as Cleared by OMB.docx","document_id":"FDA-2015-N-2002-1975"},{"title":"TAB C 2016-308 Jurisdiction Final Rule as Cleared by OMB","document_id":"FDA-2015-N-2002-1974"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-2002","supporting_documents_count":50,"docket_id":"FDA-2015-N-2002","regulation_id_number":null,"title":"Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products","checked_regulationsdotgov_at":"2017-01-29T06:00:18Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":2193,"subtype":null,"title":"Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”","toc_doc":"Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding Intended Uses","toc_subject":null,"topics":["Drugs","Labeling","Medical devices","Reporting and recordkeeping requirements","Smoking","Tobacco"],"type":"Rule","volume":82}