Tobacco

U.S. Supreme Court to Review FDA’s Denial of Flavored Vape Products

Agency files appeal after U.S. Fifth Circuit Court of Appeals slams approach of rejecting marketing denial orders
U.S. Supreme Court
Photograph: Shutterstock

The U.S. Supreme Court on Tuesday agreed to consider whether the Food and Drug Administration (FDA) acted properly of barring two makers of flavored liquid for e-cigarettes from marketing their products.

The justices of the Supreme Court are expected to hear the case FDA v. Wages and White Lion Investments LLC, dba Triton Distribution, in the next term, which begins in October.

According to court documents, the question presented is “whether the court of appeals erred in setting aside FDA’s denial orders as arbitrary and capricious.”

The FDA filed an appeal with the Supreme Court after the U.S. Fifth Circuit Court of Appeals in New Orleansruled on January 3 for the agency to reconsider its marketing denial orders (MDOs) for the e-cigarette companies.

The lower court ruling said that the FDA acted arbitrarily and capriciously in rejecting consideration of marketing plans from Triton Distribution and Vapetasia LLC, makers of flavored liquid e-cigarettes. 

Eric Heyer, a partner at Thompson Hine LLP, which represents Triton Distribution and Vapetasia LLC, told CSP Daily News that “Triton looks forward to having the Supreme Court review FDA’s surprise, after-the-fact imposition of new study requirements and failure to follow its own guidance for applicants for marketing authorization for flavored ENDS products.”

Last month, the FDA issued marketing granted orders to Njoy LLC for four menthol-flavored e-cigarette products: Njoy Ace Pod Menthol 2.4%, Njoy Ace Pod Menthol 5%, Njoy Daily Menthol 4.5% and Njoy Daily Extra Menthol 6%. The announcement marks the first non-tobacco flavored e-cigarette products to be authorized by the FDA.

To date, the FDA has authorized 27 tobacco- and menthol-flavored e-cigarette products and devices.

The FDA, which took charge of regulating e-cigarettes in 2016, declined to comment on this story, saying it would not comment on possible, pending or ongoing litigation. 

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