The decision concludes a seven-year conflict between the cigar industry and FDA
On August 9, 2023, Judge Amit P. Mehta of the U.S. District Court of the District of Columbia issued a final Memorandum Opinion in Cigar Association of America et al. v. United States Food and Drug Administration et al., vacating the decision of the Food and Drug Administration (FDA) to deem premium cigars subject to the agency’s regulatory authority under the Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (TCA).
The decision concludes a seven-year conflict between the cigar industry and FDA. As previously reported, FDA issued a Final Rule on August 8, 2016, deeming all products meeting the statutory definition of a “tobacco product” to be subject to its regulatory authority, including premium cigars (“Deeming Rule”). In the preceding rulemaking phase, the Cigar Association of America (CAA), the Cigar Rights of America (CRA), and the Premium Cigar Association (PCA) had submitted comments to FDA regarding the usage patterns of premium cigar consumers, asserting that premium cigars did not pose the same type of public health concerns as other tobacco products. Nonetheless, in the Federal Register notice for the Deeming Rule, FDA asserted that no data had been provided to support different usage patterns and public health concerns.
The CAA, CRA, and PCA subsequently challenged the Final Rule in federal court. In July of 2022, the Court held that FDA’s decision to deem premium cigars was arbitrary and capricious, insofar as that FDA failed to consider data before it concerning the use of premium cigars and the health effects of such use and requested further briefing from the parties on potential remedies. Since then, Plaintiffs have requested that the Court vacate the Deeming Rule, while FDA has requested that the Court remand the decision without vacating it, a remedy that is typically reserved only for exceptional circumstances. Relevant case law dictates that a court must consider two factors: first, the seriousness of the rule’s deficiencies; and second, the disruptive consequences of vacating the rule.
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