FDA Tobacco Action Center
In June 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act, giving the Food and Drug Administration unprecedented authority to protect the public health by regulating tobacco products. The ultimate success of the law will depend on an active and engaged public health community that works to support the FDA with the best evidence and input available.
Take Action Today
The FDA is accepting comments to determine whether or not it should require child-resistant packaging and/or poisoning warnings for products that contain liquid nicotine. Submit your comments by August 31, 2015.
Despite the 2009 Tobacco Control Act, new and modified tobacco products are being sold without the FDA’s authorization. While the FDA could enforce the law, it is allowing the tobacco industry to continue selling these unauthorized products.
Public health groups are petitioning the FDA to implement a track and trace program to combat illicit trade. Submit your comment supporting this petition.
Sign up to receive our FDA Tobacco Action Alerts notifying you of opportunities to strengthen FDA regulation of tobacco.
- The U.S. Food and Drug Administration took the first step to regulate other products by proposing a Deeming Regulation to assert jurisdiction over other tobacco products, including e-cigarettes, cigars, “little cigars,” dissolvable products, and hookah. The agency is currently in the process of reviewing the more than 81,000 public comments submitted on this docket. Read the Consortium's comment on the proposed Deeming Regulation and view our other related resources.
Pending Citizen Petitions
- The Tobacco Control Legal Consortium, together with state and local health departments and other health organizations public health organizations, filed a Citizen Petition urging the FDA to regulate other tobacco products as stringently as it regulates cigarettes. View the petition.
- The Tobacco Control Legal Consortium and eighteen other leading public health organizations filed a Citizen Petition urging the FDA to protect America's health by prohibiting menthol as a characterizing flavor in cigarettes. View the petition and submit your supporting comment.
- The New York City Department of Health and Mental Hygieneand six national organizations are petitioning the FDA to establish a “track-and-trace” system to monitor the distribution of cigarettes and other tobacco products. Submit your comment supporting this petition.
- R.J. Reynolds is petitioning the FDA to weaken the required smokeless tobacco warning label. Submit your comment opposing this harmful petition.
- The University of Maryland has petitioned the FDA to assert jurisdiction over and begin regulating cigars. Submit your comment in support of this petition.
Current Requests for Information
- None at this time.
Public Health Priorities for FDA Tobacco Regulation
View Action Center Resources
- 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)
- 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)
- A Dangerous Loophole in the Process for FDA Approval of New Tobacco Products (2015)
- Family Smoking Prevention and Tobacco Control Act: Litigation Update (September 24, 2014)
- 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 (2013)
- Highlights of Citizen Petition to FDA on Menthol as a Characterizing Flavor (2013)
- Getting Scientific Data to the FDA (2012)
- Citizen Petitions: An Underutilized Tool in Tobacco Regulation (2012)
- Freedom of Information Act and the FDA (2012)
- Federal Regulation of Tobacco and Its Impact on the Retail Environment (2012)
- Telling the Public Health Story to the FDA: How the FDA Regulates Tobacco through the Rulemaking Process (2012)
- 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)
- The Tobacco Product Gatekeeper (2014)
- A Dangerous Loophole (2014)
- Tobacco Industry Exploitation (2014)
- The FDA's Misplaced Priorities (2014)
- The Deeming Regulation: Lessons Not Learned (2014)
- A Tool to Protect Public Health (2014)
- Why Should I Care About a Deeming Regulation? (2014)
- A Deeming Regulation: Expanding FDA Regulation of Tobacco Products (2014)
- Calculating the “Benefits” of Smoking: How the FDA’s Economic Model Hinders Tobacco Regulation (September 25, 2014)
- The Tobacco Control Act Four Years Later: Living up to its Promise? (June 24, 2013)
- Beyond Cigarettes: Federal Regulation of Other Tobacco Products (May 21, 2013)
- Pressing the FDA on Menthol (November 13, 2012)
- Telling the Public Health Story to the FDA's Center for Tobacco Products (May 1, 2012)
The tobacco industry has been busy challenging provisions of the Tobacco Control Act since the law passed in 2009. The Consortium has developed litigation resources to explain what is at stake in each lawsuit and track their progress through the court system.
- Litigation Update (last updated September 24, 2014)
- Cigarette Graphic Warnings and the Divided Federal Courts (2013)
About the FDA Tobacco Action Center
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.
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
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.