After SCOTUS arguments on sweet vape flavors, some lawyers hope opinion brings more FDA clarity
FDA v. Wages and White Lion Investments, which was argued before the high court in December, focused on whether the New Orleans-based 5th U.S. Circuit Court of Appeals erred when it set aside FDA denial orders banning the flavored vapes as arbitrary and capricious. (Image from Shutterstock)
When it comes to fruity puffs, the Food and Drug Administration traditionally believes the stakes are more sour than sweet.
The key questions pitting flavored vape manufacturers against the FDA: Are flavored vapes marketed to teens? Are vapes healthier than traditional cigarettes? And what exactly is the FDA requesting from the vaping industry?
It’s been a confusing and contentious issue since e-cigarettes, also known as vapes, were introduced to the American market in the mid-2000s. The electronic devices heat liquid cartridges, which contain nicotine and flavoring, into an inhalable aerosol.
The battle has come to a head, with the U.S. Supreme Court weighing in on vape flavors with names like Jimmy the Juice Man Peachy Strawberry. FDA v. Wages and White Lion Investments, which was argued before the high court in December, focused on whether the New Orleans-based 5th U.S. Circuit Court of Appeals erred when it set aside FDA denial orders banning the flavored vapes as arbitrary and capricious. Under the Family Smoking Prevention and Tobacco Control Act, the FDA can authorize a product only if the applicant can demonstrate the product is appropriate for the protection of public health.
The Supreme Court also heard arguments last month in FDA v. RJ Reynolds a case concerning whether RJ Reynolds can take its challenge the FDA’s regulations to the 5th Circuit despite not having operations there. The case raises questions about jurisdictional strategy in regulatory challenges.
The FDA has argued that sweet vape flavors are particularly appealing to youths, contributing to increased underage use. In 2021, Wages and White Lion Investments filed a motion with the 5th Circuit to stay the FDA’s denials of their marketing applications for certain flavored e-cigarettes, and the stay was granted.
Eric Heyer, who represents Wages and White Lion Investments, did not provide comments to the ABA Journal.
The overall argument from the Biden administration FDA in White Lion was that vaping companies need to provide evidence showing that vapes are healthier than traditional cigarettes and that they aren’t marketed to youth. The Trump administration FDA did not respond to an ABA Journal interview request.
In September, then-presidential candidate Donald Trump posted on Truth Social that he “saved Flavored Vaping in 2019,” and he’d do it again, because it “greatly helped people get off smoking.” Trump signed legislation during his first term raising the federal minimum age for sale of tobacco products, including e-cigarettes, to 21.
Hazy direction
In 2009, the Family Smoking Prevention and Tobacco Control Act was signed into law, requiring authorization from the FDA before new tobacco products are introduced. The question of whether a product is “appropriate for the protection of the public health” is the key part of the law.
Since the law took effect, the FDA has changed various vaping manufacturer requirements multiple times, and lawsuits have followed, lawyers interviewed say. Also, there are reports of e-cigarette companies spending millions of dollars on studies to try and prove the two things the act requires for FDA approval: that vapes are a healthier option than cigarettes, and that the products aren’t marketed to youth, says Marc Scheineson, a senior counsel at Alston & Bird an a former FDA associate commissioner.
The FDA’s position simply isn’t clear, and it’s frustrating manufacturers, says Jonathan Adler, a professor at Case Western Reserve University School of Law. His academic work focuses on environmental, administrative and constitutional law.
“What is pretty clear is the FDA, faced with the overwhelming volume of applications, started taking various shortcuts,” Adler says. “Of the millions of applications, the FDA has approved three dozen and rejected virtually everything else.”
Lighting up the Supreme Court
The White Lion case involves flavors with names like Chewy Clouds Sour Grape and Killer Kustard. The original application was denied when the FDA decided the company didn’t include a sufficient study, though White Lion contends specific regulatory requirements weren’t made clear.
“More important than what happens to the individual company is what the Supreme Court says about the process the FDA is supposed to be using going forward,” Adler says. “It doesn’t mean the FDA will approve a particular product, but it will require the FDA to provide greater notice and transparency to other companies that have applications.”
The majority of SCOTUS justices appeared unconvinced there was any deviation in the evaluation of products, says Mark Samburg, senior counsel at Democracy Forward. The Washington, D.C., nonprofit that aims to advance democracy and social progress.
“There’s a reason that seven federal appellate courts have had no problem with the FDA’s denial of authorization for other similar-flavored products,” he says.
The 2nd, 3rd, 4th, 9th, 10th and District of Columbia Circuit have considered challenges to FDA denial orders and rejected them, Samburg says. According to the Congressional Research Service, the 6th and 7th Circuits have also denied petitions to stay the FDA’s denial orders.
E-cig evidence
Vapes were originally designed with the idea that they would be healthier than smoking cigarettes, but no long-term studies exist to support that, according to lawyers interviewed. Vapes contain nicotine, but less than traditional cigarettes, according to John Hopkins Medicine. Also, carcinogens, heavy metals and acrolein—a herbicide used to kill weeds that can cause lung damage—have been found in e-cigarettes, according to the American Lung Association.
According to the 2024 National Youth Tobacco Survey, conducted by the Centers for Disease Control and Prevention and the FDA, more than a quarter of youth e-cigarette users smoke daily, and 88% of e-cigarette users prefer flavored e-cigarettes—fruit flavors are the most popular, followed by candy, desserts or other sweets.
“It’s not like the FDA set out to eliminate flavored vapes, but in the process of reviewing the marketing applications, the FDA determined that the flavors of the products they were reviewing are so attractive to young people,” says Dennis Henigan, vice president for legal and regulatory affairs for the Campaign for Tobacco-Free Kids.
A study by the National Academies of Sciences found there is substantial evidence that e-cigarette use by youth and young adults increases their risk of ever of using tobacco cigarettes.
“So you can discern a correlation between the attractiveness of flavored vapes to youth and the subsequent tendency to fall into a habit of smoking,” says Dalya Farah, a product liability and personal injury attorney at Farah & Farah. The marketing of the flavored vapes additionally targets kids, with eye-catching, cartoon-laden packaging, she adds. But determining the long-term health effects of any consumer product—including vaping—requires extensive scientific research, Farah says.
Short-term e-cigarette studies have revealed potential risks like lung damage, respiratory issues and its addictive nature, but a full empirically based study is still years in the making and would require funding to conduct, she adds.
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