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Supreme Court to weigh FDA’s refusal to approve flavored vapes


Birds fly outside the U.S. Supreme Court on the day justices issue orders in pending appeals in Washington, U.S., June 24, 2024. 

Nathan Howard | Reuters

WASHINGTON —The Supreme Court on Tuesday agreed to consider whether the Food and Drug Administration acted unlawfully in refusing to approve flavored e-cigarettes that are often used by teens.

The case marks a test of the FDA’s role in approving new nicotine products at a time when new ones are proliferating.

E-cigarette makers have brought court cases around the country challenging the FDA’s decisions.

The FDA won most of them, but appealed to the Supreme Court after the 5th U.S. Circuit Court of Appeals in January ruled in favor of two vape companies seeking to have their products approved. The appeals court concluded that the FDA had failed to correctly assess the companies’ requests in violation of a federal law called the Administrative Procedure Act.

That case was brought by Triton Distribution, which makes e-liquids for vape pens in such flavors as “Signature Series Mom’s Pistachio” and “Suicide Bunny Mother’s Milk and Cookies,” and Vapestasia, which has sought approval for flavors including “Iced Pineapple Express” and “Killer Kustard Bluebery.”

Three other appeals brought by vape companies that lost in lower courts are also pending at the high court.

The FDA has consistently declined to approve flavored vapes, saying they may be a health risk because they may encourage young people to use tobacco, although they remain widely available. The companies say the FDA got it wrong, arguing that their products can be used to help people stop smoking.

The FDA has concluded that the potential benefits to helping adult smokers quit do not outweigh the potential health risks to young people.

Meanwhile, there has been a growth in teens using other products containing nicotine.

The FDA recently approved menthol-flavored e-cigarettes for the first time. It has approved other e-cigarette products as well.

Amid the debate on the potential health dangers of vaping, the FDA this month also rescinded its ban on Juul selling its vape products.

The justices will hear oral arguments and decide the case in the next Supreme Court term, which begins in October and ends in June 2025.



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