Federal Court Rules That FDA Was Arbitrary and Capricious in Deeming Premium Cigars Subject to the Tobacco Control Act

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Since it became effective in 2016, the cigar industry has mounted several challenges to the U.S. Food and Drug Administration’s (FDA) “Deeming Rule,” which extended the Agency’s tobacco product authority beyond cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco, to all products that meet the “tobacco product” definition in the Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act.[1]

In 2020, the United States District Court for the District of Columbia (the “Court”) issued an order vacating the health warning requirements for cigars and pipe tobacco set forth in 21 CFR §§ 1143.3 and 1143.5, and remanding the final Deeming Rule’s warning requirements for cigars and pipe tobacco back to the Agency.[2]

On August 19, 2020, the Court issued a ruling, in part, to prohibit FDA enforcement of the Tobacco Control Act’s premarket authorization requirement for premium cigars until after the Agency considers developing a streamlined substantial equivalence process specifically for premium cigars.

Read full article here.

Azim Chowdhury, Josephine Hsu & Daniel McGee – Continuum of Risk – 2022-07-14.

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