Bidi Vapor LLC v. U.S. Food and Drug Administration, et al, No. 21-13340 (11th Cir. 2022)
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Petitioners petitioned for review concerning whether it was arbitrary and capricious for the Food and Drug Administration (FDA or Administration) to issue marketing denial orders to six tobacco companies for their electronic nicotine-delivery systems without considering the companies’ marketing and sales-access-restriction plans designed to minimize youth exposure and access. The Administration refused to consider the marketing and sales-access-restriction plans.
The Eleventh Circuit granted the petitions for review, set aside the orders of the Administration, and remanded to the Administration. The court concluded that it was arbitrary and capricious for the Administration to ignore the relevant marketing and sales-access restriction plans do not mandate a different result on remand. The court acknowledged the evidence in the record cataloged by the dissent of the serious risk to youth, and it may be that the Administration will conclude on remand that the marketing and sales-access restriction plans submitted in the tobacco companies’ applications do not outweigh those risks. The court wrote that it decides only that the Administration must at least consider the relevant evidence before it, which includes the companies’ marketing and sales-access-restriction plans.
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