Newswise — Just published: “FDA-Required Tobacco Product Inserts & Onserts – and the First Amendment,” Food and Drug Law Journal, March 2017 (pdf available upon request). This legal analysis examines:

−The FDA’s regulatory authority to provide consumers with information via tobacco products and their labeling;-How actively FDA could do that within existing First Amendment constraints; and−New approaches to interpreting and applying the federal Tobacco Control Act and the First Amendment.

“All prescription and over the counter drugs are regulated by the FDA and come with detailed inserts, onserts, or package labeling that provides consumers with warnings, instructions for use, and other important product and product use information (e.g., how to identify harms from use so that they can be quickly identified and treated or otherwise addressed).  The same should be done for tobacco products that deliver nicotine, an addictive drug, along with even larger health risks and no offsetting benefits,” says author Eric N. Lindblom, JD, of the O’Neill Institute for National & Global Health Law at Georgetown University Law Center. (Read more of his opinion on the O’Neill Institute blog.)

Abstract: In 2012, a federal court of appeals struck down an FDA rule requiring graphic health warnings on cigarettes as violating First Amendment commercial speech protections. Tobacco product inserts and onserts can more readily avoid First Amendment constraints while delivering more extensive information to tobacco users, and can work effectively to support and encourage smoking cessation. [Inserts are small printed leaflets, typically providing product information for consumers, placed inside the product package; onserts are similar leaflets temporarily stuck to the outside of product packages that consumers can pull off, open, and read.] This paper examines FDA’s authority to require effective inserts and onserts and shows how FDA could design and support them to avoid First Amendment problems. Through this process, the paper offers helpful insights regarding how key Tobacco Control Act provisions can and should be interpreted and applied to follow and promote the statute’s purposes and objectives. The paper’s rigorous analysis of existing First Amendment case law relating to compelled commercial speech also provides useful guidance for any government efforts either to compel product disclosures or to require government messaging in or on commercial products or their advertising, whether done for remedial, purely informational, or behavior modification purposes.

About the authors:Corresponding author: Eric N. Lindblom, JD, is the Director for Tobacco Control and Food & Drug Law at the O’Neill Institute for National & Global Health Law at Georgetown University Law Center, and the former Director of the Office of Policy at FDA’s Center for Tobacco Products. [email protected], 202-661-6688.

Micah L. Berman, JD, is an Assistant Professor at the College of Public Health and the Moritz College of Law at Ohio State University. [email protected], 614-688-1438

James F. Thrasher, PhD, MA, MS, is an Associate Professor in the Department of Health Promotion, Education & Behavior at the Arnold School of Public Health, University of South Carolina. [email protected], 803-777-4862