Nicotine Product Standard ANPRM
On March 16, 2018, the FDA issued an advance notice of proposed rulemaking, seeking information as it considers the development of a product standard setting a maximum level of nicotine in cigarettes.
July 2018
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.
Sign-Up for Alerts!
Sign up for our FDA Tobacco Action Alerts, notifying you of opportunities to strengthen FDA regulation of commercial tobacco.
Current Action Items
Flavored Products ANPRM
On March 21, 2018, the FDA issued an advance notice of proposed rulemaking, seeking information on the role of flavors in tobacco products, including the role of menthol in cigarettes.
Premium Cigar ANPRM
On March 21, 2018, the FDA issued an advance notice of proposed rulemaking, seeking information about premium cigars.
Draft Paper on Illicit Trade
The FDA is seeking public comment on a draft concept paper regarding the potential for illicit trade markets to develop in response to a tobacco product standard.
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.
FDA’s New Regulatory Plan
On July 28, 2017, the FDA announced a comprehensive regulatory plan for tobacco products that establishes a cohesive agency-wide approach to nicotine.
Federal Deregulation
Since taking office, the Trump administration has taken several steps to delay, halt, and rollback federal regulation. Some of these actions have had larger impacts than others.
Current Litigation
Current Status of Deeming Litigation
The FDA’s deeming regulation is being challenged in multiple courts around the country. This is the current status of each case.
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
Action Center Resources
From Canada to California: Building Momentum on Menthol Restrictions
September 20, 2017
Pressing the FDA on Menthol
November 13, 2012
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.
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.