FDA Tobacco Action Center

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.

Fact sheet clarifying two conflicting decisions related to graphic warnings on cigarette packages and advertisements: the 6^th 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

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.

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

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 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 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.

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.

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).

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.

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 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.

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

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

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.

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

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

Potential arguments to make in comments to the FDA on the draft guidance on modified risk tobacco products.

Suggested talking points to include in comments to the FDA on the draft guidance regarding harmful constituents in tobacco products.

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.

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

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.