On Monday, the Supreme Court was divided on whether the Food and Drug Administration had outlawed Millions of flavored e-cigarettes allowed to be sold in US over concerns about nicotine addiction among young people.
In oral arguments in a case that could have a major impact on public health, the courts confronted the tobacco industry that the government had issued clear and variable requirements for new product applications and failed to provide companies with adequate notice.
“The FDA changed its position on the studies that were needed” to show that the products have benefits for existing smokers that offset the risks to youth, argued Eric Heyer, an attorney representing vape manufacturers Triton Distribution and Vapetasia, which are seeking the green light to market. – Liquids like “Jimmy the Juice Man Peachy Strawberry” and “Iced Pineapple Express”.
Federal law requires sellers of new nicotine products to provide regulators with scientific evidence to show that the products would promote public health, but the statute does not specify what evidence is necessary and sufficient. The FDA’s guidance on meeting this requirement is at the center of the case.
“Their argument is that the orientation was really a moving target, that they weren’t clear or that you changed your orientation over time,” said Judge Clarence Thomas, who appeared sympathetic to vape manufacturers.
“That’s their argument,” responded Biden administration attorney Curtis Gannon, representing the FDA, adding, “But I think the key is that they knew from the statute that they had to make that comparison in terms of what benefit they had to existing smokers and that to non-smokers and young people.” by measuring the costs of attraction”.
Judge Neil Gorusch suggested that the companies may not have been given “fair warning” about how they could comply with the law. “Wouldn’t due process require notice and an opportunity to be heard?” he asked Gannon.
There have been electronic cigarettes and vaporizers that deliver nicotine without the harmful effects of smoking. rising popularity. Children’s flavors such as fruit, candy, mint, menthol, and dessert are not approved by the FDA and are marketed illegally.
While vaping among youth is on the decline, more than 1.6 million children use the products, according to the Centers for Disease Control and Prevention. Almost 90% of them consume brands with illegal flavors.
The manufacturers have admitted that their products may appeal to young people, but that “growing scientific evidence” shows that “flavours are key to getting older smokers to switch and stay away from combustible cigarettes”.
A federal appeals court ruled in favor of the companies last year, saying the agency acted arbitrarily. If the Supreme Court upholds this ruling, it could clear the way for the wider marketing and sale of nicotine-flavored products.
The court’s three liberal justices appeared to share the government’s view that the FDA did not illegally move the target posts during the process and that the companies lacked the evidence to win approval.
Since 2009, when Congress passed legislation aimed at reducing tobacco use among youth, the government has almost universally denied requests from tobacco companies to sell nicotine-flavored e-liquids, citing the risks of addiction among minors.
The FDA said in this case that the two companies did not provide enough evidence that the benefits of flavored electronic products outweighed the risks of linking children to tobacco smokers.
In this undated file photo, the United States Supreme Court is shown in Washington, DC
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“I’m totally confused,” Justice Sonia Sotomayor told Heyer. “What (the FDA) said was that what you provided was not enough.”
Judge Ketanji Brown Jackson said he was “disgusted” with Heyer’s argument that the FDA had explicitly articulated its own standard.
“I guess I don’t really see what the surprise is here, or what the change is here,” said Justice Elena Kagan. “There’s not a lot of mystery here about what the FDA was doing. You might not agree with it, because you think, in fact, that the 40-year-old world wants to do blueberry vaping, but you can’t tell. The FDA hasn’t told you what it thinks on that front.” .
Judge Brett Kavanaugh, who could be a critical vote in the case, expressed sympathy for the industry’s complaint about discretionary government regulation, but suggested he was not convinced the FDA acted unreasonably.
“If the agency says (claims of benefit to adult smokers) don’t outweigh the harm to youth, we’ve reviewed everything, we know everything, of course they know everything that’s out there, that’s kind of the end of it, right?” Kavanaugh asked.
Even if they lose the case, several judges have noted, vaporizer manufacturers can reapply to the FDA for approval in a new application.
The first Trump administration came down hard on the marketing and sale of sweet vaporizers and flavored candy, with President-elect Donald Trump saying on the campaign trail that he wants to “save” flavored vaporizers.
“We don’t know exactly what it’s going to look like,” Heyer said. But, he added, his customers “can’t wait for it”.
Nearly a quarter of high school students who use e-cigarettes use illegal menthol-flavored varieties, according to the 2023 National Youth Tobacco Survey.
Josie Shapiro, the national youth ambassador for the Campaign for Tobacco-Free Kids 2024, who testified before Congress about the dangers of nicotine addiction, said illegal flavored vaporizers linked 14-year-olds.
“I think any flavored product marketed as gum or some type of candy is going to catch kids’ eyes,” Shapiro said. “I’m still an addict, and I’m trying to fight my addiction. Frankly, the FDA needs to regulate all flavored tobacco to flavor ‘tobacco’ products and take them off the market.”
Public health experts have credited the FDA’s crackdown on nicotine-flavored products with helping reduce the number of teens vaping from “epidemic” levels five years ago.
The case, Food and Drug Administration v. Wages and White Lion Investments, LLC, will be decided before the Supreme Court’s term ends in June 2025.
ABC News’ Patty See contributed to this report.
