Supreme Court upholds FDA decision banning flavored vapes
The Supreme Court ruled unanimously Wednesday that the FDA properly refused to approve flavored vape products by two e-cigarette companies because regulators determined they were too great a risk to public health.
The ruling overturned a decision by the 5th Circuit Court of Appeals that found that the FDA unfairly changed its standards while assessing products made by Triton Distribution and Vapetasia.
The FDA's denial orders were 'sufficiently consistent with its predecisional guidance,' Justice Samuel Alito wrote for the court. 'Affected parties may have come away with the impression that the agency would apply a less demanding standard of proof than is evident in the denial orders the FDA ultimately issued, but in the end, we cannot say that the FDA improperly changed its position with respect to scientific evidence, comparative efficacy, or device type.'
The e-liquid flavor products marketed by Triton and Vapetasia include dessert, candy and fruit flavors such as 'Killer Kustard Blueberry,' 'Rainbow Road' and 'Pineapple Express.' They were among millions of other flavored e-cigarette products that the FDA barred in 2021 due to their attractiveness to young people and addictive nature, the court said.
E-cigarettes hit the market in 2007 and soon became ubiquitous. Use surged after 2010, reaching 11.2 million American adults by 2016, according to a study cited by the court.
A 2009 law called the Tobacco Control Act gave the FDA broad powers to restrict the sale and marketing of new tobacco products that would negatively impact public health, especially in terms of the potential for addiction.
Justice Sonia Sotomayor wrote separately to clarify that she did not agree with the majority that the FDA had been unwilling to clearly state what companies needed to prove to get their products approved. The agency instead gave manufacturers 'some flexibility as to the forms of evidence,' while sticking to its duty to ensure products were ultimately safe for the general public, Sotomayor said.
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Bloomberg
an hour ago
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Merck Says It Wins US Approval for Shot to Prevent Infant RSV
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