{"abstract":"In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled \"Regulatory Freeze Pending Review,\" this action delays the effective date of the final rule (\"Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding `Intended Uses' \"), which published on January 9, 2017, from February 8, 2017, until March 21, 2017.","action":"Final rule; delay of effective date.","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/2017/02/07/2017-02485.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 9501","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The effective date of the rule amending 21 CFR Chapter I published at 82 FR 2193 on January 9, 2017 is delayed until March 21, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-2002"],"dockets":[],"document_number":"2017-02485","effective_on":"2017-03-21","end_page":9502,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/02/07/2017-02485.xml","html_url":"https://www.federalregister.gov/documents/2017/02/07/2017-02485/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/2017-02485?publication_date=2017-02-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-02-07/2017-02485/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1043,"last_updated":"2026-04-24 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-02-07/pdf/2017-02485.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-02485.pdf?1486388752","publication_date":"2017-02-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/02/07/2017-02485.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":"2017-02-27T06:00:19Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":9501,"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”; Delayed Effective Date","toc_doc":"Amendments to Regulations Regarding \"Intended Uses\" Revised Effective Date","toc_subject":"Clarification of When Products Made or Derived from Tobacco Are Regulated as Drugs, Devices, or Combination Products:","topics":[],"type":"Rule","volume":82}