FDA Tobacco Action Center

Our FDA Project

The Family Smoking Prevention and Tobacco Control Act gives the Food and Drug Administration (FDA) the authority to protect the public health by regulating commercial tobacco products. We educate and mobilize the public health community to engage with the FDA to promote bold and effective commercial tobacco regulation.

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Sign up for our FDA Tobacco Action Alerts, notifying you of opportunities to strengthen FDA regulation of commercial tobacco.

Current Action Items

E-Cigarette Draft Guidance

The FDA issued a new guidance document outlining proposed changes to the agency’s use of enforcement discretion with respect to premarket review of e-cigarettes, cigars, and other products subject to the deeming rule.

Camel Snus MRTP Application

R.J. Reynolds Tobacco Co. (RJR) has filed a Modified Risk Tobacco Product Application to the FDA for several varieties of its Camel Snus product.

iQOS MRTP Application

Philip Morris International (PMI) has filed a Modified Risk Tobacco Product Application to the FDA for its iQOS system.

Current Litigation

Other Tobacco Control Act Litigation

In addition to the challenges to the FDA’s deeming rule, other FDA regulations and the preemptive scope of the Tobacco Control Act have been litigated as well. We track this litigation and provide easy-to-understand summaries of the cases.

Public Health Priorities

Federal Regulation of Menthol Tobacco

The Tobacco Control Act prohibited all flavors in cigarettes, except the most common and harmful one: menthol. Despite overwhelming evidence of the health harms of menthol and the public health benefit of removing it from the market, the FDA has yet to take action. For resources related to menthol regulation click learn more below.



E-Cigarettes and Other Tobacco Products

The FDA published the final deeming rule on May 10, 2016, allowing the agency to begin regulating e-cigarettes. But since that date, the agency has delayed the implementation of several important requirements. At the same time, tobacco companies are aggressively challenging the deeming in court. Click below to learn more about the history of FDA regulation of e-cigarettes and get all of the latest updates.

FDA Premarket Review of Tobacco Products

The FDA has unprecedented authority to regulate tobacco products, including the ability to decide whether or not a new tobacco product can be introduced to the market. However, the implementation of this authority is rife with problems. Click learn more below for information on the importance of premarket review and how the FDA should improve the process to better protect health.


Action Center Resources

Latest Resources
Citizen Petitions
Comments
Fact Sheets
Talking Points
Videos
Webinars
Extensions and an Epidemic: The FDA's Gatekeeping Authority for E-Cigarettes
2019
The FDA's New Tobacco Regulatory Plan
2018
WEBINAR: Too Little, Too Late? The FDA’s New Enforcement Guidance
March 2019
WEBINAR: The FDA Tools to Tackle the JUUL Epidemic
February 2019
WEBINAR: Unanswered Questions about the FDA’s Juul Enforcement Blitz
January 2019
Lawsuits Challenging the FDA’s Deeming Rule
March 2019
Asking the FDA to regulate all tobacco products
September 6, 2013
Asking the FDA to prohibit menthol as a characterizing flavor in cigarettes
April 12, 2013
Calling on the FDA to implement a track-and-trace program to monitor tobacco products
March 6, 2013
Public Health Groups' comments on the Proposed Rule on Content and Format of Substantial Equivalence Reports
2019
Comments to the FDA on Modifications to Compliance Policy for Certain Deemed Tobacco Products; Draft Guidance for Industry
2019
Comments to the FDA on Modifications to Compliance Policy for Certain Deemed Tobacco Products (CTFK)
2019
Comments to the FDA on Enforcement Policy for Certain Marketed Tobacco Products
2019
Comments to the FDA on ANPRM for Regulation of Premium Cigars
2018
Comments to the FDA on ANPRM for Flavored Products
2018
Comments to the FDA on ANPRM for Nicotine Level of Combusted Cigarettes
2018
Public Health Groups' comments to the FDA on Illicit Trade Draft Concept Paper
2018
Public Health Groups' comments to the FDA on Nicotine Standard ANPRM
2018
Public Health Groups' comments to the Center for Tobacco Products on Existing Enforcement Opportunities
2018
Comments to Center for Drug Evaluation and Research on NRT Enforcement Opportunities
2018
Comments to the FDA on Existing Center for Tobacco Products Regulatory and Information Collection Requirements
2018
Comments to the FDA on Tobacco Industry’s Good Manufacturing Practices Proposal
2017
Comments to the FDA on Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delay
2017
Comments on Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products
2017
Comments to the FDA on Draft Guidance on The Prohibition of Distributing Free Samples of Tobacco Products
2017
Consortium Comment on FDA Draft Guidance
2016
Comments to the FDA on Procedures for Premarket Tobacco Product Submissions
2016
Comments to the FDA on the psychosocial predictors of initiation into tobacco use
2016
Comments to the FDA on Clarification of When Tobacco-Derived Products are Regulated as Drugs, Devices, or Combination Products
2015
Comments to the FDA on Swedish Match MRTP Application
2015
Comments to the FDA upon reopening of the docket for Swedish Match MRTP
2015
Comments to the FDA to inform the agency's future regulation of e-cigarettes
2015
Comments to the FDA on Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine and E-Liquids
2015
Comments to the FDA on the Proposed Deeming Regulation
2014
Comments on Petition of Lorillard for Enforcement Discretion with Respect to Premarket Approval Requirements for New Tobacco Products
2014
Comments to FDA on Preliminary Evaluation of Menthol in Cigarettes
2014
Comments to the Tobacco Products Scientific Advisory Regarding Approaches to Evaluation of Modified Risk Tobacco Products
2014
Comments to FDA on Health Document Submission
2013
Comments to FDA on Smokeless Tobacco Product Warning Statements
2013
Comments to FDA on Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research
2013
Comments to FDA on Tobacco Industry's Product Manufacturing Practices Proposal
2013
Comments to the Tobacco Product Scientific Advisory Committee Regarding Harmful and Potentially Harmful Constituents
2013
Comments to the Tobacco Product Scientific Advisory Committee Regarding Modified Risk Tobacco Products
2013
Consortium Testimony - FDA Public Hearing on NRT
2012
Comments to FDA on Guidance Regarding Testing for Harmful and Potentially Harmful Constituents
2012
Comments to FDA on Guidance for Industry on Modified Risk Tobacco Product Applications
2012
Comments to FDA on Petition of Center for Tobacco Regulation, Litigation and Advocacy for Rulemaking to Assert Jurisdiction Over Cigars
2012
Comments to FDA on Tobacco Industry's Product Manufacturing Practices Proposal - Coalition of Health Groups
2012
Comments on Petition of R.J. Reynolds & Am. Snuff Co. for Rulemaking to Adjust Statutory Smokeless Tobacco Warning
2012
Comments to FDA on Required Warnings for Cigarette Packages and Advertisements
2011
Comments to FDA on Guidance for Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Products to Protect Children and Adolescents
2011
Comments to FDA on the Impact of Dissolvable Tobacco Use on Public Health
2010
Extensions and an Epidemic: The FDA's Gatekeeping Authority for E-Cigarettes
2019
Getting Scientific Research to the FDA
2018
Telling the Public Health Story to the FDA
2018
The FDA's New Tobacco Regulatory Plan
2018
Lawsuits Challenging the FDA’s Deeming Rule
2018
The Deeming Regulation: FDA Authority Over E-Cigarettes, Cigars, and Other Tobacco Products
2017
State and Local Tobacco Regulation in a Post-Deeming World
2016
The FDA’s Premarket Review of Tobacco Products Fails to Fully Protect Public Health
2015
The Deeming Regulation: The FDA's Questions for the Public Health Community
2014
The FDA Takes Small Steps to Expand Tobacco Regulation
2014
A Deeming Regulation: What is Possible Under the Law
2014
Racketeers at the Table: How the Tobacco Industry is Subverting the Public Health Purpose of Tobacco Regulation
2013
Highlights of Citizen Petition to FDA on Regulating all Tobacco Products
2013
Cigarette Graphic Warning Labels and the Divided Federal Courts
2014
Highlights of Citizen Petition to FDA on Menthol as a Characterizing Flavor
2013
Citizen Petitions: An Underutilized Tool in Tobacco Regulation
2012
Freedom of Information Act and the FDA
2016
Federal Regulation of Tobacco and Its Impact on the Retail Environment
2012
FDA Proposes Product Standard for Smokeless Tobacco
2017
Urge the FDA to Strengthen the Proposed Deeming Regulation
2014
Tell the FDA to Prohibit Menthol in Cigarettes
2013
Encourage the FDA to Implement a Third-Party Governance System for Tobacco Product Research
2013
Encourage the FDA to Reject the Tobacco Industry's GMP Proposal and to Implement Strong, Meaningful Regulations
2013
Encourage the FDA to Strengthen Warning Labels for Smokeless Tobacco
2013
Encourage the FDA to Keep the Existing Warning Labels for Smokeless Tobacco
2012
Modified Risk Tobacco Products: Suggested Talking Points for Comments to FDA
2012
Harmful and Potentially Harmful Constituents: Suggested Talking Points for Comments to FDA
2012
Why Should I Care About a Deeming Regulation?
2014
A Deeming Regulation: Expanding FDA Regulation of Tobacco Products
2014
Too Little, Too Late? The FDA’s New Enforcement Guidance
March 20, 2019
The FDA Tools to Tackle the JUUL Epidemic
February 26, 2019
Unanswered Questions about the FDA’s Juul Enforcement Blitz
January 23, 2019
From Canada to California: Building Momentum on Menthol Restrictions
September 20, 2017
The Federal Government and Tobacco Control: The Immediate Future and Beyond
June 06, 2017
The Deeming Rule Explained: What the Public Health Community Needs to Know
May 19, 2016

About The FDA Tobacco Action Center

FDA Regulatory Authority

The Family Smoking Prevention and Tobacco Control Act, gives the U.S. Food and Drug Administration unprecedented authority to regulate tobacco products. The FDA’s regulatory process requires an informed and engaged public to support bold regulation. The tobacco industry continues to commit tremendous resources to this process and the public health community must do all that it can to counter the industry’s influence.

Public Health Legal Technical Assistance

To assist public health officials, advocates, lawyers, and researchers, the Consortium’s FDA tobacco project is working to make the FDA’s process easy to navigate. Ultimately, we are working to achieve several goals:

  • Provide strong, evidence-based information to help the FDA enact strong tobacco regulations to promote public health.

  • Help the FDA defend its decisions against the tobacco industry’s legal challenges.

  • Proactively engage with the FDA to shape its agenda for the benefit of public health.

Contact Our Staff Attorneys

Desmond Jenson: (651) 695-7612 Desmond.Jenson@mitchellhamline.edu

Natalie Hemmerich: (651) 695-7666 Natalie.Hemmerich@mitchellhamline.edu

PLEASE NOTE that although commenting on FDA regulations does not traditionally constitute lobbying, each organization must consider its own limitations based on its legal structure, funding sources and relevant law. If you have any questions regarding what activities are permitted for your organization, please contact your funder or an attorney licensed in your jurisdiction.