The Supreme Court is scheduled Monday to consider the regulation of flavored e-cigarettes in a case that illustrates an enduring public health conundrum: how to keep kids away from sweet-flavored, addictive vapes while giving adult smokers better options to help them quit cigarettes.
The justices will hear arguments about the Food and Drug Administration’s rejection of some of the products, and they could upend how the agency handles e-cigarettes, adding to the court’s curbing of the federal government’s regulatory powers. The hearing comes as President-elect Donald Trump has vowed to protect the vaping industry.
Agency backers say a ruling that rolls back the FDA’s decisions on e-cigarettes has the potential to undermine its congressionally mandated authority to regulate tobacco products. And it could force the FDA to reconsider millions of applications to market e-cigarette products, overwhelming an agency strapped for resources.
“It would really set a new standard of the [court] substituting its own decisions for the decisions of an expert agency like the FDA,” said Andrew J. Twinamatsiko, a director of the Center for Health Policy and the Law at Georgetown University Law Center.
Justices will review a lower-court ruling that found the FDA, which rejected more than a million similar applications, acted in an “arbitrary and capricious” way in denying market authorization to two vape companies, Triton Distribution and Vapetasia. The lower court said that action sent companies on a “wild goose chase” of requirements.
The companies offer liquids with fanciful names: killer kustard, strawberry parfait, iced pineapple express. The FDA declared that the flavored addictive nicotine products appealed too much to underage users. The companies – which have been calling on the FDA to revisit their applications – did not return requests for comment.
Vapetasia describes vapes as cigarette alternatives that can help smokers desperate to quit. The electronic devices don’t burn tobacco, meaning they don’t pose the same threat of inhaling toxic chemicals as traditional cigarettes do.
The vaping industry argues that the FDA has manipulated agency standards because of political pressure and that it ignores mounting evidence that e-cigarettes do more good than harm.
“Science has not been at the forefront of what FDA has based its decisions on,” said Tony Abboud, executive director of the Vapor Technology Association, a trade group representing manufacturers, retailers and others.
Monday’s oral arguments add to years of legal battles between an industry worth billions of dollars and the FDA, which regulates electronic nicotine delivery systems that involve heating nicotine liquid solutions to make an inhalable aerosol.
The FDA announced in 2016 it would begin regulating e-cigarettes as tobacco products as lawmakers and public health officials expressed alarm at a dramatic rise in youth vaping. Critics blamed the increase on advertising by e-cigarette company Juul Labs that showcased young models on websites and social media. As part of a company “reset,” Juul halted television, print and digital advertising and took its sweet and fruity flavors off the market. It has also allocated more than $1 billion to states to settle lawsuits over its marketing practices.
In 2020, the Trump administration issued restrictions on flavored e-cigarettes but exempted tobacco and menthol flavors.
After President Joe Biden took office, the FDA in 2022 ordered Juul off shelves after raising concerns about “insufficient and conflicting data” on damage to DNA and potentially harmful chemicals leaching from the company’s cartridges. But this summer, the FDA reversed its ban on Juul products, which had remained on store shelves, saying the agency had “gained more experience” with scientific issues involving e-cigarette products.
The FDA had been overwhelmed by millions of applications for new tobacco products including e-cigarettes, although the agency notes one company might seek authorization to market tens of thousands of products that vary in flavors, sizes and variety but rely on largely the same evidence. It has rejected more than a million sweet and fruity vaping products, but many remain under review despite pressure from companies and lawmakers to finish.
In recent years, illegal disposable vapes with fruity flavors and made in China have flooded store shelves, prompting outrage from Congress and public health groups about the FDA’s lack of enforcement.
As the Supreme Court case loomed, the agency in June approved several menthol vaping liquids made by NJOY, a subsidiary of tobacco giant Altria Group. The decision, criticized by anti-tobacco advocates, marked the first time the FDA approved flavored vaping products. The agency deemed that the benefit to adult smokers looking to quit outweighed the risks to youths. In all, the FDA has approved 34 tobacco- and menthol-flavored vape products.
Such risk-reward calculations lie at the heart of the legal fight before the Supreme Court.
In rejecting the applications of Las Vegas’s Vapetasia and Texas manufacturer Triton Distribution, the FDA noted they relied on an industry-funded review of studies that concluded there was not enough quality research on whether flavored vapes can help smokers quit, according to a court filing by Solicitor General Elizabeth B. Prelogar, whose office is representing the agency.
The agency determined that tobacco-flavored e-cigarettes offer the benefit of helping smokers quit without the same degree of risk of youth uptake posed by other flavored products, the filing said. The agency has said nicotine from vapes can adversely influence development of adolescent brains, affecting attention, learning and memory, and their use may be associated with asthma, chronic bronchitis and emphysema.
Seven appeals courts have backed the FDA’s denials of e-cigarettes in similar cases. Two others ruled against the FDA.
That includes the U.S. Court of Appeals for the 5th Circuit in New Orleans. That court agreed with companies’ contention that the FDA had shifted its scientific goal posts by abruptly requiring long-term studies that would show whether flavored vapes that aren’t tobacco-flavored are more effective than tobacco varieties in helping people stop smoking. The FDA instituted what amounted to a blanket ban on flavored vapes, the court ruled.
The famously conservative court known for repeatedly striking down federal regulations did not order the FDA to approve the applications but directed the agency to conduct another review.
Legal experts regard the case as a major test of the agency’s authority under the 2009 Family Smoking Prevention and Tobacco Control Act. The FDA appealed to the Supreme Court, asking that the appellate court’s decision be overturned, arguing that the agency properly considered the applications and that appeals court judges misinterpreted administrative law.
The 5th Circuit hasn’t always ruled against the FDA. In March, it upheld the agency’s requirement that graphic images, including photos of smoke-damaged lungs, be added to cigarette packages and ads. The Supreme Court in November declined to hear the case.
In the vape case, the justices could issue a narrow ruling that preserves the authority of the FDA but requires it to reconsider Vapetasia’s and Triton Distribution’s applications.
The wider debate about the risk of vapes appears poised to continue.
FDA product denials reflect a broader stubbornness – rooted in suspicion of Big Tobacco – by public health officials and researchers loath to accept evidence that the products are not as harmful as once believed, said Jasjit S. Ahluwalia, a Brown University School of Public Health researcher. Studies have shown e-cigarettes work better than nicotine patches and as well as certain prescription medications in helping people quit cigarettes, Ahluwalia said.
“Let’s be very clear – they are dramatically safer than cigarettes,” Ahluwalia said.
Ahluwalia, a physician and professor of medicine, stressed that governments should restrict underage access to such products, particularly unregulated products predominantly made in China. But he rejected arguments that vapes lead to cigarette use, citing continued drops in youth cigarette smoking.
“That is an unbelievably positive public health story,” Ahluwalia said. “The gateway hypothesis never turned out to be true.”
Vape supporters also point to an annual federal survey showing a dramatic decline in e-cigarette use by teenagers since 2019 as evidence that e-cigarettes do not pose a problem of epidemic proportion.
But anti-vape groups credit awareness campaigns and aggressive FDA restrictions for the decline. They maintain that it is unacceptable to have an estimated 1.6 million U.S. youth users – a figure that could rise again if the Supreme Court rules against the agency.
Such a decision “would be a gift to Big Tobacco and unleash a wave of youth tobacco addiction,” Sen. Dick Durbin (D-Illinois), a vocal critic of the tobacco industry, said in a statement to The Washington Post.
Tobacco companies have increasingly turned to Black and LGBTQ+ groups to sway public opinion in favor of vaping. Companies are also making vaping devices with screens resembling video games that critics say are clearly aimed at hooking young people.
While fewer high-schoolers are using e-cigarettes, those who do use puff more frequently, “indicating that the level of addiction among these students has been rising,” public health organizations, including the Campaign for Tobacco-Free Kids and the American Academy of Pediatrics, wrote in an amicus brief to the Supreme Court.
Federal officials concede that more work needs to be done to reduce usage, as many youth vapers say they want to stop but need help doing so.
Roughly half of young people who use e-cigarettes have said they intend to quit – and 1 in 3 report attempts to quit in the past year, said Cristine Delnevo, director of the Rutgers Institute for Nicotine & Tobacco Studies.
“More recently, we’ve seen increased demand for support among this population to quit vaping,” Delnevo said.
(c) Washington Post