Regulatory Submissions

Regulatory Submissions to FDA

Date	Description	PDF
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6.1.2012	Comments on Draft Guidance for Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke.
6.1.2012	Comments on Draft Guidance for Modified Risk Tobacco Product Applications.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12.22.2011	Comments on Draft Guidance for Applications for Premarket Review of New Tobacco Products.
11.8.2011	Comments on Draft Guidance for Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products.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09.08.2010	Comments on Draft Guidance for “Harmful and Potentially Harmful Constituents”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01.22.2010	Comments on Draft Guidance on tobacco health document submission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11.13.2009	Comments on Draft Guidance on listing of ingredients in tobacco products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

Regulatory Submissions

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