{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to delay the effective date of amendments to the existing medical product \"intended use\" regulations, contained in the final rule published January 9, 2017, until further notice. This final rule delays the effective date of the amendments to allow further consideration of the substantive issues raised in the comments received regarding the amendments. This action does not delay the effective date of the portions of the January 9, 2017, final rule that 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 (FD&C Act), which remains March 19, 2018.","action":"Final rule; partial 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/2018/03/16/2018-05347.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":"83 FR 11639","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective March 16, 2018, the amendments made to Sec. Sec. 201.128 and 801.4, revised at 82 FR 2193 (January 9, 2017), delayed at 82 FR 9501 (February 7, 2017) until March 21, 2017, and further delayed at 82 FR 14319 (March 20, 2017) until March 19, 2018, are delayed indefinitely. Section 1100.5, added at 82 FR 2193 (January 9, 2017), delayed at 82 FR 9501 (February 7, 2017) until March 21, 2017, and further delayed at 82 FR 14319 (March 20, 2017) until March 19, 2018, is effective March 19, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-2002"],"dockets":[],"document_number":"2018-05347","effective_on":"2018-03-16","end_page":11642,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/03/16/2018-05347.xml","html_url":"https://www.federalregister.gov/documents/2018/03/16/2018-05347/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/2018-05347?publication_date=2018-03-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-03-16/2018-05347/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":1637,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-03-16/pdf/2018-05347.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-05347.pdf?1521117921","publication_date":"2018-03-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/03/16/2018-05347.txt","regulation_id_number_info":{"0910-AH94":null},"regulation_id_numbers":["0910-AH94"],"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":"2018-04-05T10:00:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":11639,"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”; Partial Delay of Effective Date","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; Partial Delay of Effective Date","toc_subject":null,"topics":[],"type":"Rule","volume":83}