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.
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
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.
Philip Morris International (PMI) has filed a Modified Risk Tobacco Product Application to the FDA for its iQOS system.
The FDA’s deeming regulation is being challenged in multiple courts around the country. This is the current status of each case.
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
Action Center Resources
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
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.