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.  This is particularly important given the antics of the tobacco industry in the regulatory process so far. The tobacco industry has opposed nearly every action the agency has taken and has already filed four lawsuits in efforts to block various provisions in the law. The public health community must provide a strong counterbalance to the tobacco industry’s immense resources to ensure that the FDA enacts bold regulations to protect public health.


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Action Opportunities:

Proposed Regulations

  • None at this time.

Citizen Petitions

  • 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 Hygiene and 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.

Requests for Information

  • None at this time.

Goals:

The Consortium’s FDA tobacco project is designed to mobilize the public health community to improve and support FDA regulation of tobacco.  To ensure that the FDA is supported by an informed and engaged public health community, we are working to achieve several goals: 

  1. Provide strong, evidence-based information to help the FDA enact strong tobacco regulations to promote public health;
  2. Help the FDA defend its decisions against the tobacco industry’s legal challenges; and
  3. Proactively engage with the FDA to shape its agenda for the benefit of public health.

Litigation Challenges:

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.

Contact FDA Tobacco Project staff attorneys:

Desmond Jenson: desmond.jenson@wmitchell.edu or (651) 695-7612

Joelle Lester: joelle.lester@wmitchell.edu or (651) 695-7603

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.

Check out our FDA Tobacco Action Center resources!

For Other Related Topics:

 

Featured Publications

  A Deeming Regulation: What is Possible Under the Law (2014)

Frequently asked questions about what a deeming regulation is, generally speaking, and what will happen once the U.S. Food and Drug Administration issues a proposed regulation expanding its authority over tobacco products.

  Why Should I Care About a Deeming Regulation? (2014)

Short clip that explains why, under federal law, the U.S. Food and Drug Administration must “deem” certain products to be subject to the Tobacco Control Act before it can exert its regulatory authority over them.  Watch now.

  A Deeming Regulation: Expanding FDA Regulation of Tobacco Products (2014)

Short video clip that explains generally what happens once the U.S. Food and Drug Administration “deems” a product to be subject to the Tobacco Control Act.  Watch now.

  Tell the FDA to Regulate All Tobacco Products (2013)

The FDA has opened a docket for public comments on our Citizen Petition urging the agency to assert jurisdiction over and regulate all tobacco products as stringently as it regulates cigarettes and smokeless tobacco.

  Racketeers at the Table: How the Tobacco Industry is Subverting the Public Health Purpose of Tobacco Regulation (2013)

Law synopsis describing the tobacco industry’s long history of misleading the public about the dangers of its products and explaining how the industry’s interest and behavior prevent meaningful participation in the regulation of its products.

  Urge the FDA to Regulate All Tobacco Products (2013)

Suggested talking points to help you craft your comments on the FDA tobacco docket.

  Comments to FDA on Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research (2013)

Comments to the FDA on behalf of the Tobacco Control Legal Consortium to assist the agency in designing an effective third-party governance system for tobacco product research.

  FDA Citizen Petition – Asking FDA to Regulate all Tobacco Products (2013)

Citizen Petition to Food & Drug Administration on behalf of the Tobacco Control Legal Consortium and a coalition of state and local public health organizations and their national membership organizations asking the FDA to regulate e-cigarettes, cigars, “little cigars,” hookah and other tobacco products currently free of federal regulation.

  Highlights of Citizen Petition to FDA on Regulating all Tobacco Products (2013)

Highlights of Citizen Petition on behalf of a coalition of state and local public health organizations and their national membership organizations asking the FDA to assert jurisdiction over and regulate all tobacco products.

  How and Why Society for Research on Nicotine and Tobacco Members Should Participate in the FDA's Rulemaking on Menthol (2013)

Slides from August 22, 2013 webinar presented by SRNT, Tobacco Control Legal Consortium, FDA, Campaign for Tobacco-Free Kids, and Legacy.

  FDA Seeks Input on Menthol

The FDA released a scientific evaluation of the health effects of menthol cigarettes and wants public input. Comments are due November 22, 2013.

  Tell the FDA to Prohibit Menthol in Cigarettes

These suggested talking points will help you craft your comments on the FDA menthol docket.

  Comments to FDA on Tobacco Industry's Product Manufacturing Practices Proposal (2013)

Comment to FDA urging the FDA to consider the past actions of the tobacco industry when weighing the industry’s proposed tobacco product manufacturing regulations.

  Beyond Cigarettes: Federal Regulation of Other Tobacco Products

Date: 
Tue, 05/21/2013
Time: 
12:00PM

The Family Smoking Prevention and Tobacco Control Act of 2009 granted the U.S. Food and Drug Administration (FDA) the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco and any other tobacco products that the FDA "deems" to be within its authority. So far, the FDA hasn't issued a "deeming" regulation to assert jurisdiction over other tobacco products, meaning that products like e-cigarettes, hookah, little cigars and dissolvables are completely unregulated at the federal level.

  Cigarette Graphic Warning Labels and the Divided Federal Courts (2013)

Fact sheet clarifying two conflicting decisions related to graphic warnings on cigarette packages and advertisements: the 6th Circuit ruling that upholds the Tobacco Control Act’s graphic warning requirement and the D.C. Circuit decision that overturned the FDA’s graphic warning rule

  Encourage the FDA to Reject the Tobacco Industry's GMP Proposal and to Implement Strong, Meaningful Regulations (2013)

Talking points for those interested in commenting on whether the FDA should implement the tobacco industry’s proposal to implement a regulation to govern the manufacturing process for tobacco products.

  Encourage the FDA to Implement a Third-Party Governance System for Tobacco Product Research (2013)

Talking points for those interested in commenting on whether the FDA should accept an Institute of Medicine recommendation to implement a system of third-party governance for tobacco product research.

  Highlights of Citizen Petition to FDA on Menthol as a Characterizing Flavor (2013)

Highlights of Citizen Petition on behalf of many leading national organizations asking the FDA to prohibit menthol as a characterizing flavor in cigarettes.

  FDA Citizen Petition - Asking FDA to Prohibit Menthol as a Characterizing Flavor in Cigarettes (2013)

Citizen Petition to Food & Drug Administration on behalf of the Tobacco Control Legal Consortium and many other national organizations focused on public health and ethnic health outcome disparities, asking the FDA to prohibit menthol as a characterizing flavor in cigarettes.

  Comments to FDA on Smokeless Tobacco Product Warning Statements (2013)

Comments from twenty-four national organizations on what changes, if any, to the current statutory warnings on smokeless tobacco products would promote greater public understanding of the risks associated with the use of smokeless tobacco products.

  Citizen Petition to FDA - Track and Trace System to Monitor Tobacco Products (2013)

Citizen petition requesting that the FDA fulfil its responsibilities under the Federal Food, Drug and Cosmetic Act, and implement a track and trace system to monitor manufacturing and flow of tobacco products from production through distribution to retail outlets.

  Encourage the FDA to Strengthen Warning Labels for Smokeless Tobacco (2013)

Information for those interested in submitting comments asking the FDA to strengthen warning labels that appear on smokeless tobacco products and to review these warning labels periodically to evaluate their effectiveness.

  Consortium Testimony - FDA Public Hearing on NRT - 12-17-2012

Testimony of Kathleen Hoke Dachille on behalf of the Consortium, at FDA hearing on issues related to the regulation of nicotine replacement therapies, urging FDA to develop a comprehensive plan for regulating tobacco and nicotine products (Dec. 17, 2012).

  Legal Update -- Fall 2012

This special edition, which is dedicated to issues related to the federal regulation of tobacco products, features an interview with, and profile of, William B. Schultz, Acting General Counsel of the U.S. Department of Health and Human Services, as well as other resources and information on FDA tobacco regulation, and a salute to Mitchell Zeller, a national expert in public health law.

  Encourage the FDA to Keep the Existing Warning Labels for Smokeless Tobacco (2012)

Information for those interested in commenting on RJR's Citizen Petition asking the FDA to issue a new regulation altering the text of the smokeless tobacco product warning statement.

  Comments on Petition of R.J. Reynolds & Am. Snuff Co. for Rulemaking to Adjust Statutory Smokeless Tobacco Warning (2012)

Comments of several public health and medical groups opposing the petition of R.J. Reynolds and American Snuff Co. to alter the text of the statutorily-required smokeless tobacco product warning statement, and asking the FDA to deny the petition.

  Family Smoking Prevention and Tobacco Control Act: Litigation Update (November 2013)

Guide to recent and pending ligation that challenges or implicates the Family Smoking Prevention and Tobacco Control Act.

  Getting Scientific Data to the FDA (2012)

Overview of rulemaking process and how scientists and academics in the public health community can be active participants in this process.

  Pressing the FDA on Menthol

Date: 
Tue, 11/13/2012
Time: 
12:00PM

The Family Smoking Prevention and Tobacco Control Act of 2009 granted the FDA the authority to address the crushing public health burden of menthol in tobacco products, especially on youth, African-Americans, and the LGBTQ community. Unfortunately, in the three years since the law was enacted, the FDA has studied the issue but failed to act on this authority. This webinar will discuss what the public health community can do to press the FDA to take bold action on menthol.

Download the Powerpoint slides here.

  Freedom of Information Act and the FDA

Information on how the public health community can use Freedom of Information Act requests to maximize its impact on the federal regulation of tobacco.

  Citizen Petitions: An Underutilized Tool in Tobacco Regulation (2012)

Overview of how tobacco control advocates can use citizen petitions to influence the FDA's regulation of tobacco.

  Modified Risk Tobacco Products: Suggested Talking Points for Comments to FDA (May 2012)

Potential arguments to make in comments to the FDA on the draft guidance on modified risk tobacco products.

  Harmful and Potentially Harmful Constituents: Suggested Talking Points for Comments to FDA

Suggested talking points to include in comments to the FDA on the draft guidance regarding harmful constituents in tobacco products.

  Telling the Public Health Story to the FDA's Center for Tobacco Products

Date: 
Tue, 05/01/2012
Time: 
12:00PM

This webinar provides an overview of federal regulation of tobacco and explains how to interact directly with the FDA’s Center for Tobacco Products, including how to submit comments to the FDA on tobacco regulation, to promote public health objectives.

  Telling the Public Health Story to the FDA: How the FDA Regulates Tobacco through the Rulemaking Process (2012)

Overview of the rulemaking process under the FDA's Family Smoking Prevention and Tobacco Control Act.

  Federal Regulation of Tobacco and Its Impact on the Retail Environment (2012)

Overview of the federal tobacco restrictions that impact the retail environment, with a focus on provisions in the Family Smoking Prevention and Tobacco Control Act and related regulations. This fact sheet also includes policy options that states and many local governments can consider to further restrict tobacco in retail settings.