A recent ruling by a federal appeals court has compelled the U.S. Food and Drug Administration (FDA) to reconsider its refusal to allow two manufacturers of flavored e-cigarette liquids to market their products. The court deemed the FDA’s decision arbitrary and capricious, emphasizing the agency’s failure to review the companies’ marketing plans.
The 5th U.S. Circuit Court of Appeals in New Orleans, in a 9-5 decision, overturned a prior ruling from July 2022 by a three-judge panel. Circuit Judge Andrew Oldham, appointed by former President Donald Trump, asserted that the FDA had solicited detailed marketing plans from e-cigarette companies, deeming them crucial for preventing youth abuse. However, the agency subsequently denied the applications without examining the plans, falling short of its obligation to deal straightforwardly with companies.
Oldham emphasized the importance of adhering to principles when evaluating the actions of unelected administrators within government branches, likening the FDA’s regulatory decisions to a lack of straightforwardness. Eric Heyer, representing liquid manufacturers Triton Distribution and Vapetasia LLC, expressed satisfaction with the ruling, hoping it would prompt the FDA to provide specific communication regarding approval criteria.
The FDA, which initially categorized e-cigarettes as tobacco products subject to agency review, faced pressure to restrict flavored e-cigarettes due to the growing trend of youth vaping. Triton and Vapetasia sought approval for products with flavors like sour grape, pink lemonade, crème brulee, and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”
Since 2021, the FDA has rejected over a million applications, including those from Triton and Vapetasia, asserting a lack of evidence showing benefits for adult smokers. The dissenting opinion by Circuit Judge Catharina Haynes argued that the FDA’s decision was reasonable, emphasizing the irrelevance of marketing plans if the products lacked benefits for adults.
The FDA has yet to provide a comment on the recent court decision.
