{"abstract":"The Food and Drug Administration (FDA or we) is further delaying the effective date of a final rule published in the Federal Register of January 9, 2017. In the Federal Register of February 7, 2017, we delayed until March 21, 2017, the effective date of the final rule. This action further delays the effective date of the rule until March 19, 2018. FDA has received a petition from affected parties which raises questions about the amendments to the regulations regarding \"intended uses\" and requests that FDA reconsider these amendments. FDA is further delaying the effective date to invite public comment on the important substantive issues raised by the petition and to allow additional time to fully evaluate these issues and any other issues raised in response to this request for comments. FDA is seeking input on some specific questions, and is also interested in any other pertinent information or comments stakeholders would like to provide regarding any aspect of the final rule, or with respect to issues relating to \"intended uses\" generally.","action":"Final rule; further delay of effective date; request for comments.","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/2017/03/20/2017-05526.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 14319","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective date: The effective date for the rule amending 21 CFR chapter 1 published at 82 FR 2193 on January 9, 2017, delayed at 82 FR 9501 on February 7, 2017, is further delayed until March 19, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-2002"],"dockets":[],"document_number":"2017-05526","effective_on":"2017-01-09","end_page":14324,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/03/20/2017-05526.xml","html_url":"https://www.federalregister.gov/documents/2017/03/20/2017-05526/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/2017-05526?publication_date=2017-03-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-03-20/2017-05526/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":2498,"last_updated":"2026-04-24 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-03-20/pdf/2017-05526.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-05526.pdf?1489754752","publication_date":"2017-03-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/03/20/2017-05526.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":"2017-05-20T05:00:25Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":14319,"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”; Further Delayed Effective Date; Request for Comments","toc_doc":"Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products","toc_subject":"Regulations Regarding Intended Uses Amendments:","topics":[],"type":"Rule","volume":82}