Cigar Association of America et al. v. United States Food and Drug Administration et al.

Top Food and Drug Cases, 2021

Do larger and more prominent health warnings deter people from smoking cigars? This question was at the center of Cigar Association of America, et al. v. United States Food and Drug Administration, et al., a case decided by the US Court of Appeals for the District of Columbia Circuit. Analysis Group Principal Rene Befurt and Senior Analyst Genna Liu were part of a team of authors that analyzed the case for this year’s edition of the Food and Drug Law Institute publication Top Food and Drug Cases.

The matter involved a challenge by a group of cigar associations to the “Deeming Rule,” a regulation promulgated by the Food and Drug Administration (FDA), under which it can deem tobacco products subject to the same regulations imposed on cigarettes and other forms of tobacco already covered. Under the rule, cigars were subjected to rules dictating the size and prominence of health warnings in cigar packaging and advertising. Reversing a lower court, the court of appeals held that the FDA’s implementation of the Deeming Rule violated the Tobacco Control Act and Administrative Procedure Act, in part because the agency failed to sufficiently explain how the warnings would affect the number of cigar smokers or the cessation rate of cigar smoking.

In their analysis, Dr. Befurt and Ms. Liu pointed out that because the FDA will need to present “concrete evidence to bridge the gap between an updated warning label and its impact on consumer behavior,” the agency would be wise to consider empirical marketing research to meet this demand. In particular, they wrote, “survey research methods are particularly appropriate for evaluating consumer responses to new labelling options.”

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MacMenamin N, Befurt R, Liu G