With the U.S. Supreme Court weighing in on vape flavors with names like Jimmy the Juice Man Peachy Strawberry in FDA v. Wages and White Lion Investments, the industry is anxiously awaiting the decision.
The case was argued before the high court in December and it 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, which is 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.
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.
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.
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.”
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.”
