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Regulatory Submissions

Regulatory Submissions to FDA

Date Description PDF
8.7.2014 Comments on FDA Proposed Deeming Regulation
10.21.2013 Menthol Request for Comments – PSE Response.
10.21.2013 Menthol Request for Comments – ANPRM Responses.
9.25.2012 Comments on Pretesting of Tobacco Communications.
7.18.2012 Comments on Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products.
6.1.2012 Comments on Draft Guidance for Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke.
6.1.2012 Comments on Draft Guidance for Modified Risk Tobacco Product Applications.
5.22.2012 Comments on Experimental Study of Graphic Cigarette Warning Labels.
2.13.2012 Comments on Experimental Study on Public Display of Lists of Harmful and Potentially Harmful Tobacco Constituents.
1.11.2012 Comments on Non Face To Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products.
12.22.2011 Comments on Draft Guidance for Applications for Premarket Review of New Tobacco Products.
11.8.2011 Comments on Draft Guidance for Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products.
10.11.2011 Joint Comments on Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke.
09.23.2011 Comments to FDA on Scientific Evaluation of Modified Risk Tobacco Product (MRTP) Applications
06.23.2011 Comments to FDA on the TPSAC Report on Menthol Cigarettes
03.23.2011 The Industry Menthol Report
02.04.2011 Comments on Guidance for demonstrating substantial equivalence for tobacco products
01.11.2011 Technical comments on proposed rule implementing graphic warning requirements
01.11.2011 Joint comments on proposed rule implementing graphic warning requirements
09.08.2010 Comments on Draft Guidance for “Harmful and Potentially Harmful Constituents”
08.02.2010 Response to FDA request for information regarding youth smoking, advertising and promotion of cigarettes
07.26.2010 Response to FDA request for information on tobacco product advertising and promotion to youth and racial and ethnic minority populations
07.19.2010 Comments on Advance Notice of Proposed Rulemaking on outdoor advertising restrictions
02.18.2010 Comments on use of tobacco marketing descriptors to convey modified risk
01.22.2010 Comments on Draft Guidance on tobacco health document submission
01.08.2010 CRTR comments on request for information for approved tobacco retailer training program
11.13.2009 Comments on Draft Guidance on listing of ingredients in tobacco products
09.29.2009 Comment on tobacco product establishment registration and submission of health documents (reporting burden estimate)
09.29.2009 Comments on request for information on the implementation of the FSPTCA

Lorillard Submissions and Presentations to TPSAC

Date Description PDF
03.17.2011 03-17-2011 Submission to TPSAC of draft Executive Summary of Industry Menthol Report
02.10.2011 Presentation to TPSAC at February 10-11, 2011 meeting
10.07.2010 Submission to TPSAC for October 7-8, 2010 meeting
09.27.2010 Joint submission to TPSAC for September 27, 2010 meeting
07.15.2010 Slides for presentations made by Lorillard for July 15-16, 2010 TPSAC meeting
07.15.2010 Submission to TPSAC to address inaccuracy in FDA presentations at March 31, 2010 meeting
07.15.2010 Background material submission to TPSAC – Responses to FDA requests for information on menthol cigarettes asked by TPSAC at the March 31, 2010 meeting
06.06.2010 Submission to TPSAC for Constituents Subcommittee meeting
03.31.2010 Submission to TPSAC for March 31, 2010 meeting

Third Party Submissions to TPSAC

Report Date TPSAC Meeting Description PDF
01.19.2011 01.10.2010 and 02.10.2011 Covance Study – The role of menthol flavoring in smoking initiation, cessation and other smoking behaviors- A search and methodological evaluation of the literature
12.20.2010 02.10.2010 Compass Lexecon Study – Estimating consequences of a ban on the legal sale of menthol cigarettes