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Mitigating the Incidence and Severity of Injuries and Other Harms

Cigar Association of America v. U.S. Food & Drug Administration

Overview

Cigar Association of America v. U.S. Food & Drug Administration (U.S. District Court – D.C. Feb. 3, 2020): The U. S. District Court for D.C. granted summary judgment in favor of the cigar industry rejecting the U.S. Food and Drug Administration’s (FDA’s) argument that its health-warning label requirements under the deeming rule apply to premium cigars. Cigar merchants’ associations, manufacturers, and retailers brought an action against FDA and others challenging FDA’s application of the deeming rule’s health warning requirements to premium cigars. The court held that requiring premium cigars to include health-warnings labels for packaging and advertisements violated the Administrative Procedures Act because it was arbitrary and capricious and not a product of reasoned decision making. FDA claimed the warnings were necessary to address misimpressions about the health risks of cigar use. However, FDA failed to analyze whether consumers were actually mis- or under-informed about the health effects of premium cigars. The court vacated the deeming rule’s warning requirements for premium cigars and remanded the rule back to FDA for further proceedings.  Read the decision here.

View all cases in the Judicial Trends in Public Health – March 17, 2020.

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