Regulatory Filings - Altria

The Family Smoking Prevention and Tobacco Control Act, enacted in June 2009, granted the U.S. Food and Drug Administration the authority to regulate tobacco products.

Currently, the Food and Drug Administration (FDA) regulates cigarettes, cigarette tobacco, "roll-your-own" tobacco and smokeless tobacco products; however, the law allows the FDA to extend its authority to regulate other tobacco products, including cigars and pipe tobacco. The FDA has indicated that regulation of cigars is on its agenda of items for possible rule-making.

 

Regulatory Filings

To filter the documents below please select Year, Topic and Filing Type and then click on the GO button.

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TitleDateTopicFiling TypePDF Size
IOM Report on Scientific Standards on MRTPs 03/05/2012Modified Risk ProductsComments233 KB
Response to R.J. Reynolds Tobacco Company and American Snuff Company Citizen Petition 02/06/2012Health WarningsComments1 MB
Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products 01/19/2012Marketing and AdvertisingComments701 KB
Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products 01/19/2012Remote SalesComments2 MB
Draft Guidance on Premarket Review of New Tobacco Products 12/23/2011New Tobacco ProductsComments1 MB
Demonstrating Substantial Equivalence of a New Tobacco Product: Responses to FAQ’s 11/08/2011Substantial EquivalenceComments2 MB
Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke 10/11/2011ConstituentsComments1 MB
Scientific Evaluation of Modified Risk Tobacco Product Applications 09/23/2011Modified Risk ProductsComments3.6 MB
Scientific Evaluation of Modified Risk Tobacco Product Applications 08/26/2011Modified Risk ProductsComments84 KB
Dissolvable Tobacco Products 07/22/2011Dissolvable Tobacco ProductsPresentation84 KB
Tobacco Products Scientific Advisory Committee Evaluation of Dissolvable Tobacco Products* 07/19/2011TPSACLetter968 KB
Draft Guidance for Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007 06/24/2011Substantial EquivalenceComments436 KB
Submission to Participate in Site Tours Program* 06/09/2011GeneralLetter324 KB
Exemptions from Substantial Equivalence Requirements 03/22/2011Substantial EquivalenceComments2.0 MB
PM USA Report to the FDA on the Use of Menthol in Cigarettes 03/22/2011MentholSubmission9.7 MB
March 2, 2011 TPSAC meeting: Use of Menthol in Cigarettes 03/02/2011MentholComments91 KB
February 10, 2011 TPSAC meeting: Countervailing Effects of a Potential Ban on Menthol Cigarettes 02/10/2011MentholPresentation1.98 MB
February 10, 2011 TPSAC meeting: Comparisons Between Adult Menthol and Non-Menthol Smokers 02/10/2011MentholPresentation220 KB
Demonstrating Substantial Equivalence for Tobacco Products 02/08/2011Substantial EquivalenceComments1.0 MB
Exclusion of Industry Representatives and the Appropriate Protection of Proprietary Information* 02/07/2011TPSACLetter728 KB
TPSAC Process and Scientific Principles* 01/27/2011TPSACLetter194 KB
Required Warnings for Cigarette Packages and Advertisements 01/11/2011Health WarningsComments4.2 MB
Testimony of Dr. Henningfield and FDA's response* 01/06/2011TPSACLetter469 KB
Unintended Consequences and Other Countervailing Effects of a Ban on Menthol Cigarettes 12/30/2010MentholSubmission10.4 MB
Impact of Dissolvable Tobacco Products on Public Health 09/20/2010Dissolvable Tobacco ProductsComments2.25 MB
Constituents in Tobacco Products 09/08/2010ConstituentsComments682 KB
Advocacy of Dr. Connolly to TPSAC Subcommittee on Constituents* 08/26/2010TPSACLetter864 KB
Constituents in Tobacco Products 08/23/2010ConstituentsComments1.0 MB
Regulation of Outdoor Advertising 07/19/2010Marketing and AdvertisingComments1.95 MB
July 15-16, 2010 TPSAC meeting: Introduction 07/15/2010MentholPresentation35.6 KB
July 15-16, 2010 TPSAC meeting: Characerization of Menthol 07/15/2010MentholPresentation289 KB
July 15-16, 2010 TPSAC meeting: Clinical Effects 07/15/2010MentholPresentation1.05 KB
July 15-16, 2010 TPSAC meeting: Biomarkers 07/15/2010MentholPresentation342 KB
July 15-16, 2010 TPSAC meeting: Marketing Menthol Cigarettes 07/15/2010MentholPresentation128 KB
July 15-16, 2010 TPSAC meeting: Menthol Cigarettes and Smoking Initiation 07/15/2010MentholPresentation149 KB
Menthol Use in Cigarettes - Background Information 06/30/2010MentholSubmission17 MB
Proposed Extension of Collection of Information 06/22/2010GeneralComments682 KB
Conflicts of Interest and Bias of Consultants to TPSAC Subcommitte on Constituents and FDA's response* 06/04/2010TPSACLetter667 KB
Constituents in Tobacco Products 05/27/2010ConstituentsSubmission806 KB
Menthol Use in Cigarettes 03/22/2010MentholSubmission10.6 MB
Announcement of TPSAC Voting Members and FDA's response* 03/22/2010TPSACLetter2.4 MB
Timetable for Review of Applications for Modified Risk Products 02/25/2010Modified Risk ProductsComments211 KB
Use of Product Descriptors for Smokeless Tobacco Products 02/18/2010DescriptorsComments326 KB
Use of Product Descriptors for Cigarettes 02/18/2010DescriptorsComments1.1 MB
Tobacco Health Document Submissions 01/22/2010Health EffectsComments804 KB
Regulatory Framework for Harm Reduction 12/22/2009Harm ReductionComments1.89 MB
Reissuance of the 1996 Rule 12/22/2009Marketing and AdvertisingComments2.52 MB
General Principles for Implementating Federal Tobacco Regulation 12/22/2009GeneralComments760 KB
Listing Tobacco Product Ingredients 11/13/2009Reporting and RegistrationComments6.0 MB
Manufacturing Facility Registration and Tobacco Product Listing 10/30/2009Reporting and RegistrationComments715 KB
Processing and Collection of Tobacco Establishment Registration and Certain Health Information 10/01/2009Reporting and RegistrationComments569 KB


*Note: The FDA has not responded to every letter. When the Agency has, we included its responses in the links above.

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