The Supreme Court on Wednesday unanimously upheld the Food and Drug Administration’s decision to deny authorization for two companies to sell flavored e-cigarettes, delivering a win to federal regulators and reversing a lower court ruling that had temporarily undercut the agency’s tobacco control powers.
In a 9-0 opinion authored by Justice Samuel Alito, the justices concluded the FDA acted lawfully and was not “arbitrary and capricious” in rejecting premarket applications from Triton Distribution and Vapetasia. The companies had sought approval to sell vape liquids in flavors like “Killer Kustard” and “Suicide Bunny Mother’s Milk and Cookies,” which the FDA found posed a particular risk to youth.
The Supreme Court found that the FDA’s decision not to evaluate the companies’ marketing plans, despite earlier calling such plans “critical,” did not warrant reversing the agency’s determinations.
While the U.S. Court of Appeals for the 5th Circuit had ruled that the FDA blindsided the companies by applying stricter standards than its guidance suggested, the Supreme Court disagreed, stating the agency’s position had remained consistent and within its statutory discretion.
“The FDA’s denial orders were sufficiently consistent with its predecisional guidance,” Alito wrote, emphasizing that manufacturers had failed to provide “robust and reliable” scientific evidence showing their products would benefit public health.
The decision marks a significant endorsement of the FDA’s authority under the Tobacco Control Act to limit flavored e-cigarette products, which the agency says are particularly attractive to minors.
FDA RETURN-TO-WORK MANDATE RESULTS IN ‘ABSOLUTE CHAOS’
Though e-cigarettes remain widely available, most flavored varieties lack FDA approval and are technically on the market illegally.
Last year, the FDA partnered with several agencies within the Justice Department to crack down on illegal vapes and e-cigarettes in response to statistics showing nearly 10% of high schoolers used such products.