The US Supreme Court appeared sympathetic this week to arguments that the Food and Drug Administration (FDA) acted properly when it rejected applications to market fruit- and dessert-flavoured liquids for e-cigarettes.
The judges 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 1m fruit-, candy- and dessert-flavoured 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 flavoured e-cigarettes.
Judge Elena Kagan and several other judges expressed doubts that the FDA had misled the companies, reports The Washington Post.
“Everybody basically knows that flavours are particularly dangerous in terms of kids starting the use of smoking products,” said Kagan.
Health officials say 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 criticised the FDA’s denials of e-cigarette products, however, saying 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% since its peak in 2019 and is at its lowest level in a decade, according to an annual federal survey released in September.
But anti-vape groups say the estimated 1.6m US youth users is still far too many and that flavoured vaping liquids are helping to create a new generation of children addicted to nicotine.
The case this past 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 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-flavoured liquids that have a documented appeal to young people. Still, some sweet flavours that were grandfathered in under the Control Act remain on the market.
Triton Distribution, which makes e-cigarette liquids, applied to market flavours 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 flavours that included “Iced Pineapple Express” and “Killer Kustard Blueberry”.
The companies conceded in their FDA applications that surveys showed such flavours 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 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.
After legal wrangling, the full 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 judges appeared open to the companies’ arguments, questioning whether the FDA had been clear enough about its standards.
Reuters reports that the FDA found nearly one in five high school students and almost one in 20 middle school students used e-cigarettes in 2020, making e-cigarettes “the most widely used tobacco product among youth by far”.
The agency also found that youth users consistently cited flavour as a top reason for why they vape.
Over the years, the FDA has approved only 34 flavoured e-cigarette varieties, all tobacco or menthol flavoured. The agency maintains that it has not categorically banned the flavoured products, but companies seeking the agency’s approval face a particularly demanding health benefits-versus-risk legal test due to the FDA’s finding that flavoured e-cigarettes pose a “known and substantial risk” to youth.
A decision in the case will probably come early next year.
Reuters article – US Supreme Court to scrutinise FDA denial of flavoured vape products (Open access)
See more from MedicalBrief archives:
Ban flavoured vapes, says EU as as e-cigarette use rises
FDA takes flak for green-lighting menthol vapes