The Supreme Court on Monday heard arguments on federal regulation of flavored e-cigarettes in a case pitting the Food and Drug Administration (FDA) against two e-cigarette companies.
The justices considered whether the agency acted lawfully when it denied applications from companies selling fruity and dessert-flavored liquids for electronic nicotine products. The FDA determined that this flavor was too appealing to young people but not sufficiently beneficial for existing smokers looking to switch to e-cigarettes.
A ruling is expected to be rendered by the end of the Supreme Court justice's term in June.
Here's what you need to know about FDA vs. Wages and investing in White Lion.
The justices seemed sympathetic to the FDA.
The case centered on the FDA's appeal of a ruling by the ultra-conservative U.S. Court of Appeals for the Fifth Circuit that said the agency had improperly changed its standards when reviewing companies' applications.
The appeals court faulted 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.
But at least two of the Supreme Court's conservative justices have made it clear from the beginning that the FDA is acting appropriately and that it makes decisions based on whether a product is of interest to young people. It seems that he thought so.
“This is kind of the end of it, right?” Justice Brett Kavanaugh said after authorities reviewed the application and rejected it, citing risks to youth.
His opinion was echoed by Judge Amy Coney Barrett, who seemed to agree that the FDA did not significantly change its requirements during the review.
Mr. Kavanaugh also questioned why the companies would fight in court in the first place, when the relief they want — FDA review of their applications — is already an option. Although companies are free to reapply for approval after being denied, there is no guarantee that the FDA will not come to the same conclusion and deny the application again.
The three liberal justices also appear to think the FDA's stance has been consistent.
“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 the FDA was thinking,” Elena said. Justice Kagan said.
Young man smoking electronic cigarette in focus
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.
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.
White Lion Investments, doing business as Triton, makes e-liquids with flavors such as Signature Series Mom's Pistachio and Suicide Bunny Mother's Milk and Cookies. Vapetasia, another e-cigarette maker involved in the lawsuit, sought approval for flavors such as Iced Pineapple Express and Killer Custard Blueberry.
“I'm not sure what's surprising or what's changed here,” Kagan said. “Basically everyone knows that flavors are especially dangerous for children who start using smoking products.”
Justice Department attorney Curtis Gannon echoed Kagan's comments and said the FDA's position has been consistent.
“There's no wonder here…that the FDA thought there was a risk to youth,” Gannon said.
Gannon said the companies tried to prove that the flavors had “offsetting effects on adults,” but the FDA concluded that was not the case.
“Common sense would tell us that flavors like 'Mother's Milk and Cookies' would be disproportionately appealing to children,” Gannon said.
The looming impact of President Trump
At stake in 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.
Eric Heyer, a lawyer for the companies, said he didn't know what President Trump's pledge would be, but if a court orders the FDA to reconsider the application, his clients would be interested in seeing a new FDA review. He said he expected different results to be obtained.
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. ”
But Andrew J. Tuinamatsko, director of the Center for Health Policy and Law at Georgetown University Law Center, said the Tobacco Control Act has very strict standards for allowing products to be sold.
“We have to show that this product is not an entry point for non-users, but an exit for existing users of more dangerous tobacco products,” Tuinamatsko said.
So even if the new administration approves fruit- and candy-flavored products, “there's still a chance that the FDA will throw their feet to the fire,” Tuinamatsko said.
