Tobacco Industry Abuse of the Substantial Equivalence Pathway: The Case of Changing Cigarette Filter Ventilation

Micah L. Berman, Sarah Reisinger, Desmond Jenson, Richard O'Connor, K. Michael Cummings, Irina Stepanov, Warren K. Bickel, Peter G. Shields, Dorothy Hatsukami

Research output: Contribution to journalArticlepeer-review


A major goal of the 2009 Family Smoking Prevention and Tobacco Control Act (TCA) was to end the tobacco industry's practice of secretly manipulating product characteristics to increase their attractiveness and addictiveness. Under the law, "grandfathered" cigarette products that were marketed prior to the TCA's enactment do not require premarket review, but any new or modified product that is not "substantially equivalent" to a grandfathered product requires an extensive assessment by the U.S. Food and Drug Administration (FDA) of a premarket tobacco product application (PMTA) before it can be sold. This Article reports that cigarette companies appear to have used the substantial equivalence (SE) review process in previously unreported ways that avoid the otherwise-required PMTA review: they appear to have modified currently available cigarette brands by using an entirely different product as the predicate product for purposes of the SE review, and to have changed product features gradually in ways that may have significant public health effects. Thus, FDA has authorized products marketed with the same branding and same packaging to be modified substantially - and with limited, if any, notice to the public, researchers, or consumers - under the SE review pathway, contrary to the law's intent. This Article details one case study of such an SE authorization, provides broader evidence of cigarette product modifications occurring in the marketplace, and calls on FDA to take corrective action.

Original languageEnglish (US)
Pages (from-to)341-358
Number of pages18
JournalFood and Drug Law Journal
Issue number4
StatePublished - 2023

Bibliographical note

Funding Information:
Micah L. Berman, JD, Associate Professor of Public Health and Law, The Ohio State University; Sarah Reisinger, PhD, Associate Director, The Ohio State University—James Comprehensive Cancer Center; Desmond Jenson, JD, Lead Staff Attorney for Federal Regulation, Commercial Tobacco Control, Public Health Law Center; Richard O’Connor, PhD, Professor, Roswell Park Cancer Center; K. Michael Cummings, PhD, Professor, Medical University of South Carolina; Irina Stepanov, PhD, Mayo Professor, University of Minnesota School of Public Health; Warren K. Bickel, PhD, Professor, Fralin Biomedical Research Institute, Virginia Tech Carilion School of Medicine; Peter G. Shields, MD, Deputy Director, The Ohio State University—James Comprehensive Cancer Center; and Dorothy Hatsukami, PhD, Forster Family Chair in Cancer Prevention, University of Minnesota Masonic Cancer Center. Research reported in this Article was supported by grant numbers K07CA197221 and P01CA217806 from the National Cancer Institute (NCI). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NCI or the National Institutes of Health.

Publisher Copyright:
© 2023 Food and Drug Law Institute. All rights reserved.


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