Prohibition Juice Co. v. FDA, No. 21-1201 (D.C. Cir. 2022)Annotate this Case
The FDA declared that “preventing tobacco use initiation in young people is a central priority for protecting population health.” Congress has called on the FDA to regulate e-cigarette products pursuant to the Family Smoking Prevention and Tobacco Control Act.
Prohibition Juice makes flavored liquids containing nicotine derived from tobacco. Prohibition applied in September 2020 for FDA authorization to market several flavors in a range of sizes. The FDA denied those applications a year later. The FDA requires applicants to present reliable evidence of robust public health benefits exceeding known risks. Finding the manufacturers had presented insufficient evidence that their flavored products are more effective than unflavored products in helping adult cigarette smokers decrease or quit harmful tobacco uses, the FDA denied the applications. The manufacturers petitioned for a review of those denials.
The DC Circuit denied the petitions. The court explained that FDA plainly had statutory authority under the Tobacco Control Act to regulate as it did. As to the arbitrary and capricious challenges, the court held that the FDA did not change the evidentiary or substantive standard from its 2019 Guidance. The court further held that any error in the FDA’s failure to consider the marketing plans was harmless because the manufacturers failed to identify how an individualized review of the plans they submitted could have made any difference. Finally, the FDA did not otherwise fail to consider important aspects of the problem.