Supreme Court to hear case involving FDA denial of flavored vape products

The Supreme Court said Tuesday it will hear a case involving the Food and Drug Administration’s (FDA) marketing denial of two companies that sell flavored tobacco vaping products.

The court took up the appeal from FDA after the U.S. Court of Appeals for the 5th Circuit ruled at the beginning of this year that the agency’s actions in rejecting the applications from the companies was arbitrary and capricious.

The firms, Triton and Vapetasia LLC, sell flavored e-liquids, and in 2020 applied for marketing permission for flavors including sour grape, pink lemonade and creme brulee, and names including “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”

FDA denied the authorizations, finding that the companies failed to offer reliable and robust evidence to overcome the risks of youth addiction and show a benefit to adult smokers.  

The FDA has authorized the sale of only 27 e-cigarette products, and all except one have been tobacco flavored, which is not widely used by young people. It has denied millions of others. Companies seeking the agency’s approval must clear a high legal bar since such products pose a “known and substantial risk to youth,” the FDA said.

The companies sued, and the 5th Circuit, viewed as the most conservative panel in the country, heard the case. In January, a full panel of 5th Circuit judges ruled 10-6 that the FDA violated the Administrative Procedure Act by denying the applications without considering plans by the companies to prevent underage access and use.

The court said FDA asked the companies for detailed plans about how they would market their products to prevent abuse by youth, but then denied their applications without looking at them.

In court documents, FDA countered that the companies merely “called for their products to be only sold in age-gated vape and specialty tobacco shops and through age-gated online sales,” which the agency has previously said does not work. The marketing plans were not any different from plans the agency had rejected from other companies.

FDA said other federal appellate courts have ruled in their favor, creating a split and promoting the agency’s appeal to the Supreme Court.

The agency argued that if the decision from the lower court were allowed to stand, it would “seriously impair FDA’s efforts to protect young people from the harmful effects of e-cigarettes.”

The case will be heard when the Supreme Court begins its next term in October.

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