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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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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.
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.
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: