FDA-Required Tobacco Product Inserts & Onserts – And the First Amendment

Food & Drug Law Journal 72(1): 1-25 (2017)

Ohio State Public Law Working Paper No. 391

29 Pages Posted: 29 Mar 2017 Last revised: 10 Apr 2017

See all articles by Eric Lindblom

Eric Lindblom

O'Neill Inst. for National & Global Health Law - Georgetown Law

Micah L. Berman

Ohio State University (OSU) - Michael E. Moritz College of Law

James Thrasher

University of South Carolina - Arnold School of Public Health

Date Written: 2017

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. 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.

Keywords: Tobacco, First Amendment, FDA

Suggested Citation

Lindblom, Eric and Berman, Micah and Thrasher, James, FDA-Required Tobacco Product Inserts & Onserts – And the First Amendment (2017). Food & Drug Law Journal 72(1): 1-25 (2017), Ohio State Public Law Working Paper No. 391, Available at SSRN: https://ssrn.com/abstract=2942266

Eric Lindblom (Contact Author)

O'Neill Inst. for National & Global Health Law - Georgetown Law ( email )

600 New Jersey Avenue, NW
Washington, DC 20001
United States

Micah Berman

Ohio State University (OSU) - Michael E. Moritz College of Law ( email )

55 West 12th Avenue
Columbus, OH 43210
United States

James Thrasher

University of South Carolina - Arnold School of Public Health ( email )

Dept. of Health Promotion, Education & Behavior
SC
United States

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