The Supreme Court appeared sympathetic Monday to arguments that the Food and Drug Administration acted properly when it rejected applications to market fruit- and dessert-flavored liquids for e-cigarettes that the agency says are particularly attractive to young people who risk getting hooked on nicotine.
The justices heard oral arguments in an FDA appeal of a lower-court decision, which found the agency had unfairly shifted its standards for approving the vaping products while deciding on applications from two companies.
The FDA has rejected applications for more than 1 million fruit-, candy- and dessert-flavored e-cigarettes and liquids in recent years, citing surveys that show vaping has become the most popular form of tobacco product use among young people and that they prefer flavored e-cigarettes.
An e-cigarette or vape is a battery-powered device that heats a nicotine-infused liquid, turning it into a vapor that is inhaled. E-cigarettes are generally considered less harmful than traditional cigarettes but still carry health risks.
Justice Elena Kagan and several other justices expressed doubts that the FDA had misled the companies.
“I’m not really seeing what the surprise is here or what the change is here,” Kagan said. “Everybody basically knows that flavors are particularly dangerous in terms of kids starting the use of smoking products.”
The oral arguments come as President-elect Donald Trump has promised to protect the vaping industry. And it’s a major test case amid years of battles between an industry worth billions of dollars and the FDA, which regulates electronic nicotine-delivery systems. It’s also the latest case before the high court to examine the power of executive agencies, which the justices have clipped in recent terms.
The FDA began regulating e-cigarettes as tobacco products in 2016, as public health officials expressed concern about a dramatic rise in youth vaping. The booming market offered flavors such as bubble gum, mocha and margarita that were popular among middle- and high-schoolers.
Health officials have said that addictive nicotine from vapes can influence the development of adolescent brains, affecting attention, learning and memory. Vaping may also be associated with asthma, chronic bronchitis and emphysema. Some experts have criticized the FDA’s denials of e-cigarette products, however, saying that the agency is reluctant to accept evidence that the products are not as harmful as once believed to be, and that studies show e-cigarettes can help people quit smoking.
Youth e-cigarette use has declined nearly 70 percent since its peak in 2019 and is at its lowest level in a decade, according to an annual federal survey released in September. Federal health officials say the drop comes as the government has ramped up enforcement efforts. But anti-vape groups say that the estimated 1.6 million U.S. youth users is still far too many and that flavored vaping liquids are helping to create a new generation of children addicted to nicotine.
The case heard by the justices Monday revolves around a 2009 law called the Family Smoking Prevention and Tobacco Control Act, which Congress passed to combat tobacco use among adolescents. The act requires any company marketing a new tobacco product not commercially available after 2007 to get approval from the FDA.
Applicants must show that the product will be “appropriate for the protection of the public health.” That means weighing the likelihood that the product will help existing smokers, usually adults, switch to less-dangerous alternatives against the risk that it will encourage new users, typically young people, to start smoking.
The FDA makes that determination using information submitted by the applicant and other sources. If an application is denied, the applicant may challenge that decision in a federal appeals court.
The FDA has allowed the marketing of some menthol- and tobacco-flavored e-cigarettes because existing smokers have expressed interest in using them to cut down on or quit smoking cigarettes. But the agency has rejected applications featuring sweet-flavored liquids that have a documented appeal to young people. Still, some sweet flavors that were grandfathered in under the Control Act remain on the market.
Triton Distribution, which makes e-cigarette liquids, applied to market flavors with names like “Jimmy the Juice Man Peachy Strawberry” and “Suicide Bunny Mother’s Milk and Cookies” in 2020. A second company, Vapetasia, applied to market flavors that included “Iced Pineapple Express” and “Killer Kustard Blueberry.”
The companies conceded in their FDA applications that surveys showed such flavors are popular with young people but argued that they could also help adults quit smoking. However, a survey of scientific literature produced by the companies and other e-cigarette manufacturers found that there wasn’t enough research to reach that conclusion.
The FDA denied the companies’ applications in 2021, finding there was insufficient evidence that the benefits of the new products outweighed their risks. The companies appealed, arguing that the agency had said in rejecting the applications that it needed more rigorous scientific evidence than it initially announced – making it impossible for the companies to win approval.
“It’s a massive sea change,” said Eric Heyer, an attorney for the companies.
After legal wrangling, the full U.S. Court of Appeals for the 5th Circuit in New Orleans sided with the companies, overturned the denial and remanded the case to the FDA for further consideration. The FDA appealed that ruling to the Supreme Court.
Some of the court’s conservative justices appeared open to the companies’ arguments, questioning whether the FDA had been clear enough about its standards. Justice Clarence Thomas asked Deputy Solicitor General Curtis E. Gannon, who is representing the FDA, whether the agency’s standards were “a moving target.”
Gannon denied they were. He added later that the stakes of the case were high for the health of adolescents.
“There’s no mystery here … that the FDA thought there was a risk to youth,” Gannon said. “Common sense tells us that a flavor like ‘Mother’s Milk and Cookies’ is going to be disproportionately attractive to children.”
A decision in the case will probably come by the summer.
(c) Washington Post