Supreme Court justices ruled Monday that the Food and Drug Administration (FDA) acted unfairly in its regulation of flavored e-cigarettes and in its decision to bar two companies from selling products with flavors they determined pose a risk to young people. engaged in a debate about whether or not the .
The justices found that the FDA had no right in deciding to deny approval to companies selling flavors such as sour grape, pink lemonade, and crème brûlée and names such as “Jimmy the Juiceman Strawberry Astronaut.” The court examined whether he acted in an “arbitrary and capricious” manner. “Suicide Bunny Bunny Season”.
The FDA found that Triton and Vapetasia LLC did not provide reliable and solid evidence that their products overcome the risk of addiction in youth and provide benefits to adult smokers.
But the companies filed suit, claiming that the FDA changed its rules midway through its review of how the products were evaluated. They said flavored products can be used to help adults quit smoking.
Several lower courts all ruled in favor of the FDA, but the ultra-conservative U.S. Court of Appeals for the Fifth Circuit said the FDA had moved the goalposts. The court criticized the FDA's actions, arguing that the companies were told the agency needed a particular study, but then changed their minds and requested a different study.
The court did not order the FDA to approve the product, but ordered the agency to reconsider and reexamine the product.
The agency appealed to the Supreme Court, arguing that if the lower court's ruling were left in place, it would “severely undermine FDA's efforts to protect youth from the harmful effects of e-cigarettes.”
Conservative justices focused on the alleged change in standards, but the court's majority seemed largely unsympathetic to this argument.
Justice Clarence Thomas asked the government, represented by Justice Department Attorney Curtis Gannon, to respond to arguments that the guidance was “actually a moving target.”
Gannon said the agency's position has been consistent.
“Importantly, we knew from the law that we needed to weigh what the benefits were in terms of existing smokers and weigh that against the potential costs in terms of attracting non-smokers and young people. 'I think they've known all along that the FDA was concerned about the fact that the flavor was appealing to young people,' Gannon said.
Justice Brett Kavanaugh joined liberal justices in pushing back against lawyers for e-cigarette companies, pointing out that the FDA had made clear from the beginning that it was making decisions based on whether a product would be of interest to young people. did.
If a government agency reviews the application and rejects it, “that's kind of the end, right?” Kavanaugh said.
Justice Elena Kagan made a similar argument.
“The FDA has been pretty upfront about this,” Kagan told Eric Heyer, a lawyer for both companies.
“There's not much mystery about what the FDA was doing. You may disagree with it, but you can't say it doesn't tell you everything about what the FDA was thinking,” Kagan said. said.
The incident comes as teen e-cigarette use rates have fallen to their lowest levels in a decade, something federal officials have largely blamed on regulatory efforts.
Still, more than 1.6 million children use the product, according to the U.S. Centers for Disease Control and Prevention. Nearly 90% of them use illegal flavored brands, according to federal data.
The FDA has approved only 27 e-cigarette products for sale, and all but one are tobacco-flavored and are not commonly used by young people. Rejected millions of other people. The FDA said such products pose “a known and significant risk to youth,” and companies seeking FDA approval must clear high legal hurdles.
E-cigarette companies must demonstrate that their products are “appropriate for the protection of public health.”
But what looms over this case is the future of the FDA's approach to e-cigarettes. President-elect Trump has vowed to “save vaping,” but the Trump administration tried to restrict flavored e-cigarette products in 2020.
The Vapor Technology Association, an industry group representing manufacturers, retailers and others, said in a statement that the incoming administration “introduces new measures to eliminate all current litigation and any future cases following the industry-favorable SCOTUS decision.” “We can bring all cases to a swift and decisive end.” Standards for tobacco products. ”
