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


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.