By John Kruzel and Andrew Chung
WASHINGTON (Reuters) – The U.S. Supreme Court on Monday will hear the U.S. Food and Drug Administration’s defense of the agency’s refusal to let two e-cigarette companies sell flavored vape products that regulators have found to pose a significant health risk to young people .
The FDA under the administration of outgoing Democratic President Joe Biden appealed after a lower court ruled that the agency had failed to follow proper legal procedures under a federal law called the Administrative Procedure Act when it had rejected the applications to sell these nicotine-containing products.
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It is the latest case in which the justices will scrutinize the actions of a US regulator, with newly-elected Republican President Donald Trump coming to power on January 20 on the promise of broad deregulation.
The FDA rule in question, which took effect in 2016 under Democratic President Barack Obama, considered e-cigarettes tobacco products that, like traditional cigarettes, are subject to agency review under a 2009 federal law called the Tobacco Control Act called. The law requires manufacturers of e-cigarette products to apply for a license to sell nicotine vapes and e-liquids.
Two e-cigarette liquid companies, Triton Distribution and Vapetasia, filed FDA applications in 2020 for products with flavors such as sour grape, pink lemonade and crème brulee, and names such as “Jimmy The Juice Man Peachy Strawberry” and “Suicide Bunny Mother’s Milk and Cookies” – offers that critics say are intended to appeal to minors. These were rejected, as were other applications from various companies for more than a million other flavored vape products.
To gain regulatory approval, e-cigarette manufacturers must demonstrate that their product is “suitable for the protection of public health,” meaning any health benefits – such as helping traditional cigarette smokers switch to generally less harmful vaping – must outweigh the risks. to bring the new product to market.
The FDA found that nearly one in five middle school students and nearly one in 20 high school students used e-cigarettes in 2020, making e-cigarettes “by far the most commonly used tobacco product among youth.” The agency also found that youth users consistently cited taste as one of the top reasons they vape.
The FDA has only approved 34 types of flavored e-cigarettes over the years, all with a tobacco or menthol flavor. The agency maintains that it has not categorically banned flavored e-cigarette products. But companies seeking approval from the agency face an especially demanding legal test between health benefits and risks, because of the FDA’s finding that flavored e-cigarettes pose a “known and substantial risk” to young people.
Triton and Vapetasia asked the New Orleans-based 5th US Circuit Court of Appeals in 2021 to review the FDA’s denial of their applications.
In January, the full bench of 5th Circuit judges ruled by a 10-6 vote that the FDA had been arbitrary and capricious, in violation of the Administrative Procedure Act, by denying the applications without considering the companies’ plans to gain access and prevent use by minors.
The 5th Circuit’s ruling split with seven other federal appeals courts that sided with the FDA in similar cases and prompted the agency to appeal to the Supreme Court.
The Supreme Court on Nov. 25 declined to hear an appeal by RJ Reynolds and other tobacco companies of a lower court’s ruling upholding the FDA’s required graphic health warnings on cigarette packs.
The Supreme Court, with a 6-3 conservative majority, has curbed the authority of federal agencies in a series of cases in recent years.
In another high-profile case involving the FDA, the court in June decided on procedural grounds to reject a bid by anti-abortion groups and doctors to restrict access to the abortion pill mifepristone. The justices reversed the 5th Circuit’s decision to reverse the FDA’s moves in 2016 and 2021 that relaxed how the abortion pill is prescribed and distributed.
(Reporting by John Kruzel; Editing by Will Dunham)
