O'Neill Institute  |  July 6, 2016

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This working paper describes the major legal authorities and legal constraints relevant to the possibility that the U.S. Food and Drug Administration or state or local governments might attempt to require tobacco product manufacturers to provide informative tobacco product inserts or onserts to provide consumers with useful information relevant to understanding or reducing the harms and risks caused from using those tobacco products. Given that any such insert or onsert requirements could be legally challenged by affected tobacco product manufacturers, this paper carefully considers how the courts might interpret and apply the relevant legal authorities and preemption provisions in the Federal Tobacco Control Act and other federal law and in light of the First Amendment’s constraints on compelled commercial speech. Going further, the paper also provides guidance on how any government insert or onsert requirements could be structured to minimize the risk that any legal challenges would be successful, and on what related research could provide further support or guidance.

Read the working paper here.