id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id FDA-2015-N-2002-2005,FDA,FDA-2015-N-2002,Petition Interim Response from FDA OP to MIWG,Other,Letter(s),2017-08-01T04:00:00Z,2017,8,2017-08-01T04:00:00Z,,2017-08-01T14:11:37Z,,0,0,090000648299066a FDA-2015-N-2002-1990,FDA,FDA-2015-N-2002,"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; Extension of Comment Period",Rule,Extension of Comment Period,2017-05-18T04:00:00Z,2017,5,2017-05-18T04:00:00Z,2017-07-19T03:59:59Z,2017-07-19T01:01:40Z,2017-10036,0,0,09000064825dcd61 FDA-2015-N-2002-1988,FDA,FDA-2015-N-2002,"Request for Extension from MIWG, PhRMA, and BIO",Other,Request for Extension,2017-04-05T04:00:00Z,2017,4,2017-04-05T04:00:00Z,,2017-04-05T20:52:17Z,,0,0,090000648253db32 FDA-2015-N-2002-1981,FDA,FDA-2015-N-2002,"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",Supporting & Related Material,Background Material,2017-03-20T04:00:00Z,2017,3,,,2017-03-20T15:11:06Z,,0,0,090000648250ead8 FDA-2015-N-2002-1987,FDA,FDA-2015-N-2002,"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",Supporting & Related Material,Background Material,2017-03-20T04:00:00Z,2017,3,,,2017-03-20T15:20:58Z,,0,0,090000648250ef2e FDA-2015-N-2002-1983,FDA,FDA-2015-N-2002,"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",Supporting & Related Material,Background Material,2017-03-20T04:00:00Z,2017,3,,,2017-03-20T15:13:17Z,,0,0,090000648250eada FDA-2015-N-2002-1979,FDA,FDA-2015-N-2002,"Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products",Rule,Delay of Effective Date,2017-03-20T04:00:00Z,2017,3,2017-03-20T04:00:00Z,2017-05-20T03:59:59Z,2017-05-20T01:00:19Z,2017-05526,0,0,090000648251322d FDA-2015-N-2002-1984,FDA,FDA-2015-N-2002,"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",Supporting & Related Material,Background Material,2017-03-20T04:00:00Z,2017,3,,,2017-03-20T15:14:17Z,,0,0,090000648250eadb FDA-2015-N-2002-1980,FDA,FDA-2015-N-2002,"List of References for Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products",Supporting & Related Material,Background Material,2017-03-20T04:00:00Z,2017,3,,,2017-03-20T15:10:16Z,,0,0,090000648250e0c7 FDA-2015-N-2002-1985,FDA,FDA-2015-N-2002,"Reference 5 United States v. Bowen, 14-cr-00169-PAB, Rule 11(c)(1)(A) and (B) Plea Agreement and Statement of Facts Relevant to Sentencing (D. Colo. Jan. 29, 2015) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products",Supporting & Related Material,Background Material,2017-03-20T04:00:00Z,2017,3,,,2017-03-20T15:18:51Z,,0,0,090000648250eadc FDA-2015-N-2002-1982,FDA,FDA-2015-N-2002,"Reference 2 United States v. Carlson, 12-cr-00305-DSD-LIB, Amended Superseding Indictment (D. Minn. Sept. 11, 2013) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products",Supporting & Related Material,Background Material,2017-03-20T04:00:00Z,2017,3,,,2017-03-20T15:12:21Z,,0,0,090000648250ead9 FDA-2015-N-2002-1986,FDA,FDA-2015-N-2002,"Reference 6 United States v. Zeyid, 114-cr-0197, First Superseding Indictment (N.D. Ga. June 24, 2014) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products",Supporting & Related Material,Background Material,2017-03-20T04:00:00Z,2017,3,,,2017-03-20T15:19:51Z,,0,0,090000648250ef2d FDA-2015-N-2002-1977,FDA,FDA-2015-N-2002,Petition to Stay and for Reconsideration,Other,Petition(s),2017-02-09T05:00:00Z,2017,2,2017-02-09T05:00:00Z,,2017-02-09T15:45:28Z,,0,0,09000064824b6b0e FDA-2015-N-2002-1978,FDA,FDA-2015-N-2002,Acknowledgment Letter From FDA DDM to Sidley Austin LLP and Ropes & Gray LLP,Other,Acknowledgement Letter/Receipt,2017-02-09T05:00:00Z,2017,2,2017-02-09T05:00:00Z,,2017-02-09T16:48:37Z,,0,0,09000064824b6e4e FDA-2015-N-2002-1976,FDA,FDA-2015-N-2002,"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",Rule,Delay of Effective Date,2017-02-07T05:00:00Z,2017,2,2017-02-07T05:00:00Z,,2017-02-07T14:31:31Z,2017-02485,0,0,09000064824afc98 FDA-2015-N-2002-1975,FDA,FDA-2015-N-2002,TAB C 2016-308 Jurisdiction RIA as Cleared by OMB.docx,Supporting & Related Material,Background Material,2017-01-11T05:00:00Z,2017,1,,,2017-01-11T16:20:57Z,,0,0,090000648245bac6 FDA-2015-N-2002-1973,FDA,FDA-2015-N-2002,TAB B 2016-308 Jurisdiction Final Rule Redline Changes,Supporting & Related Material,Background Material,2017-01-11T05:00:00Z,2017,1,,,2017-01-11T16:19:38Z,,0,0,090000648245bac4 FDA-2015-N-2002-1974,FDA,FDA-2015-N-2002,TAB C 2016-308 Jurisdiction Final Rule as Cleared by OMB,Supporting & Related Material,Background Material,2017-01-11T05:00:00Z,2017,1,,,2017-01-11T16:20:30Z,,0,0,090000648245bac5 FDA-2015-N-2002-1972,FDA,FDA-2015-N-2002,TAB A 2016-308 Jurisdiction Final Rule as Submitted to OMB,Supporting & Related Material,Background Material,2017-01-11T05:00:00Z,2017,1,,,2017-01-11T16:19:47Z,,0,0,090000648245bac3 FDA-2015-N-2002-1971,FDA,FDA-2015-N-2002,Memorandum to FDA DDM Tobacco Jurisdiction Final Rule,Supporting & Related Material,Background Material,2017-01-11T05:00:00Z,2017,1,,,2017-01-11T16:20:00Z,,0,0,090000648245bac2 FDA-2015-N-2002-1945,FDA,FDA-2015-N-2002,"Reference 1 - Defendant's Memorandum of Points and Authorities in Support of Motion to Dismiss or Summary Judgment, Allergan Inc., v. U.S. re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:45:15Z,,0,0,0900006482453a8a FDA-2015-N-2002-1958,FDA,FDA-2015-N-2002,"Reference 14 - NCI, President's Cancer Panel re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:46:18Z,,0,0,0900006482453ea0 FDA-2015-N-2002-1950,FDA,FDA-2015-N-2002,"Reference 6 - Good-2016-Off-Label Drug Use and Adverse Drug re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:45:33Z,,0,0,090000648245417e FDA-2015-N-2002-1952,FDA,FDA-2015-N-2002,"Reference 8 - Avorn-2015-Forbidden and Permitted Statements re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:45:46Z,,0,0,0900006482454180 FDA-2015-N-2002-1953,FDA,FDA-2015-N-2002,"Reference 9 - Kapczynski-2016-Free Speech and Pharmaceutical re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:45:54Z,,0,0,0900006482454181 FDA-2015-N-2002-1947,FDA,FDA-2015-N-2002,"Reference 3 - Byron, Adolescents and Adults Perceptions of Natural Organic and re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:45:22Z,,0,0,090000648245417a FDA-2015-N-2002-1944,FDA,FDA-2015-N-2002,"Jurisdiction References List re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-19T15:02:07Z,,0,0,0900006482453a89 FDA-2015-N-2002-1959,FDA,FDA-2015-N-2002,"Reference 15 - IOM_Blueprint_2007 re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:46:21Z,,0,0,0900006482453ea1 FDA-2015-N-2002-1965,FDA,FDA-2015-N-2002,"Jurisdiction FRIA references_final2 re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:46:44Z,,0,0,0900006482453ebd FDA-2015-N-2002-1969,FDA,FDA-2015-N-2002,"Reference 4 - Size Standards Table re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:46:59Z,,0,0,0900006482453ec1 FDA-2015-N-2002-1948,FDA,FDA-2015-N-2002,"Reference 4 - Green, Evidence of the Effects of Mandatory Disclaim re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:45:26Z,,0,0,090000648245417b FDA-2015-N-2002-1951,FDA,FDA-2015-N-2002,"Reference 7 - Eguale-2016-Association of Off-Label Drug Use re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:45:36Z,,0,0,090000648245417f FDA-2015-N-2002-1956,FDA,FDA-2015-N-2002,"Reference 12 - Kesselheim, ProspectsforRegulationofOffLabelDr re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:46:11Z,,0,0,0900006482453e9e FDA-2015-N-2002-1970,FDA,FDA-2015-N-2002,"Reference 5 - U.S. Census - Tobacco and Tobacco Product re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:47:03Z,,0,0,0900006482453ec2 FDA-2015-N-2002-1960,FDA,FDA-2015-N-2002,"Reference 16 - Roditis-2015-Adolescents' Perceptions of Risks re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:46:25Z,,0,0,0900006482453ea2 FDA-2015-N-2002-1954,FDA,FDA-2015-N-2002,"Reference 10 - Cardarelli-2006-A cross-sectional evidence-bas re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:46:00Z,,0,0,0900006482454182 FDA-2015-N-2002-1957,FDA,FDA-2015-N-2002,"Reference 13 - Stafford-2008-Regulating off-label drug use--r re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:46:14Z,,0,0,0900006482453e9f FDA-2015-N-2002-1961,FDA,FDA-2015-N-2002,"Reference 17 - Vickerman-2013-Use of electronic cigarettes am re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:46:29Z,,0,0,0900006482453ea3 FDA-2015-N-2002-1963,FDA,FDA-2015-N-2002,"Reference 19 - Jurisdiction Final Rule re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:46:35Z,,0,0,0900006482453ea5 FDA-2015-N-2002-1966,FDA,FDA-2015-N-2002,"Reference 1 - Deeming Rule_FRIA re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:46:47Z,,0,0,0900006482453ebe FDA-2015-N-2002-1946,FDA,FDA-2015-N-2002,"Reference 2 - Etter-2011-Electronic cigarette_ users profile re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:45:19Z,,0,0,0900006482454179 FDA-2015-N-2002-1943,FDA,FDA-2015-N-2002,"Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Rule,Final Rule,2017-01-09T05:00:00Z,2017,1,2017-01-09T05:00:00Z,,2017-01-09T15:27:31Z,2016-31950,0,0,0900006482452b42 FDA-2015-N-2002-1955,FDA,FDA-2015-N-2002,"Reference 11 - Eisenberg, The Role of the FDA in Innovation P",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T22:50:08Z,,0,0,0900006482453e9d FDA-2015-N-2002-1962,FDA,FDA-2015-N-2002,"Reference 18 - Gallup Consumption Habits re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:46:32Z,,0,0,0900006482453ea4 FDA-2015-N-2002-1964,FDA,FDA-2015-N-2002,"Reference 20 - Janssen, Outline of the History of U.S. Drug re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:46:39Z,,0,0,0900006482453ea6 FDA-2015-N-2002-1967,FDA,FDA-2015-N-2002,"Reference 2, FDA, Safety and Effectiveness of Consumer Antiseptics Rub Products re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:46:51Z,,0,0,0900006482453ebf FDA-2015-N-2002-1949,FDA,FDA-2015-N-2002,"Reference 5 - Kesselheim-2008-Pharmaceutical Promotion to Ph re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:45:29Z,,0,0,090000648245417d FDA-2015-N-2002-1968,FDA,FDA-2015-N-2002,"Reference 3 - RTI, FDA Labeling Cost ModelFINAL re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ""Intended Uses""",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-01-09T18:46:54Z,,0,0,0900006482453ec0