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Member Research and Reports

Member Research and Reports

Ohio State: Like Prescription, OTC Drugs, Tobacco Products Should Include Educational Inserts, Onserts to Help Consumers

A study recently appearing in the Food and Drug Law Journal recommends the FDA begin requiring that the tobacco products they regulate (cigarettes, cigars, smokeless tobacco, e-cigarettes, hookah) include product educational and warning inserts and onserts for consumers.

This requirement using inserts and onserts would “avoid the First Amendment issues raised by the use of graphic imagery, while delivering more extensive information to tobacco users,” according to Mr. Micah Berman, assistant professor of public health and law at The Ohio State University, and one of the paper’s three authors.

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.

According to Berman, tobacco product onserts and inserts are “promising policy options,” yet they have not been a part of the tobacco control discussion in the United States, unlike in other countries such as Canada where they have been used effectively for years.

“Studies from Canada, where inserts have been required since 2001, show that they are an important complement to pack warnings,” said Mr. Berman.  “The tobacco industry’s use of inserts and onserts over the years also suggests that the industry believes they are an effective way of communicating with consumers.”

The article’s authors call for the FDA to move quickly to propose new graphic health warnings, but they suggest that the FDA should “also recognize that inserts and onserts can actually provide consumers with more information about tobacco-related harms and resources for quitting smoking,” said Mr. Berman.

The study, “FDA-Required Tobacco Product Inserts & Onserts – and the First Amendment,” points out that the Tobacco Control Act requires only that the FDA determine that such inserts or onserts would be “appropriate for the protection of the public health,” and that its determination not be “arbitrary or capricious.”

Even if the FDA has clear authority to require such inserts or onserts as “appropriate for the protection of the public health,” any such requirements must also fit within the constitutional constraints established by the First Amendment’s protections for “commercial speech,” according to the authors.

“Any such First Amendment concerns should be much weaker regarding insert or onsert requirements as opposed to required warning labels on product packages or labels, where, unlike with inserts or onserts, the required speech is seen prior to purchase and takes up product packaging space that the manufacturer could otherwise use for its own speech,” said Berman.

In addition to Mr. Berman, the paper’s authors include Mr. Eric Linblom, director for tobacco control and food & drug law at the O’Neil Institute for National and Global Health Law at Georgetown University Law Center, and Dr. James Thrasher, associate professor in the Arnold School of Public Health at the University of South Carolina.  Lindblom is the former director of the Office of Policy at the FDA’s Center for Tobacco Products, and Berman was previously a senior advisor in that office.

https://cph.osu.edu/news/2017/03/analysis-prescription-and-otc-drugs-tobacco-products-should-include-educational-inserts

https://www.fdli.org/2017/03/fda-required-tobacco-product-inserts-onserts-first-amendment.