Supreme Court Upholds FDA’s Rejection of Flavored Vape Applications

Supreme Court Upholds FDA’s Rejection of Flavored Vape Applications

On Wednesday, the U.S. Supreme Court largely supported the Food and Drug Administration's decision to deny flavored e-cigarette product applications from two companies, citing concerns over youth health risks.

In a unanimous ruling, the justices overturned a lower court's finding that the FDA had violated the Administrative Procedure Act when it rejected applications from Triton Distribution and Vapetasia. The companies had sought approval to market nicotine products with flavors like pink lemonade and crème brûlée.

Justice Samuel Alito, writing for the court, acknowledged that some businesses may have believed the FDA would apply a more lenient standard during the approval process. However, he ultimately concluded that the agency had not improperly shifted its stance on scientific evidence.

One unresolved issue remains: whether the FDA’s failure to assess the companies' proposed plans for preventing youth access had a significant legal impact. The case has been sent back to the lower court to reconsider that aspect under a revised standard.

Advocacy group Campaign for Tobacco-Free Kids celebrated the ruling, calling it a win for public health and youth protection.

The FDA first established regulatory authority over e-cigarettes in 2016 under the Tobacco Control Act. While it has authorized a limited number of tobacco and menthol-flavored vaping products, it has consistently rejected others, emphasizing the heightened risks flavored options pose to young users.

Despite claims from e-cigarette companies that their products aid adult smokers in transitioning away from traditional cigarettes, the FDA has maintained that the public health risks outweigh potential benefits. The agency’s data shows that nearly 20% of high schoolers and 5% of middle schoolers used e-cigarettes in 2020, making them the most commonly used tobacco product among American youth.

The Supreme Court’s decision aligns with rulings from seven other federal appellate courts that previously upheld the FDA’s authority in similar cases. However, it also marks another instance in which the high court has scrutinized the power of federal agencies—a trend seen in recent decisions involving regulations on abortion medication and cigarette health warnings.

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