Supreme Court backs FDA’s denials of flavored vaping products for now
The US Supreme Court Building is seen on Capitol Hill on February 12
By John Fritze, CNN
(CNN) — The Supreme Court on Wednesday backed a series of decisions by the US Food and Drug Administration to deny market access for flavored vaping products in a rare win for government regulators that may limit access to those products across the nation, though the justices sent the case back to an appeals court for further review.
Though a partial win for the FDA, it remains uncertain whether President Donald Trump’s administration will shift gears and free up access to the products. During the campaign, Trump vowed to “save vaping.” The vaping companies are also entitled to reapply to the FDA for approval of their products.
Justice Samuel Alito wrote the opinion for a unanimous court.
At issue were a series of FDA denials during the first year of the Biden administration for vaping products that officials said are geared toward minors with flavors like “Pink Lemonade,” “Rainbow Road” and “Jimmy the Juice Man Peachy Strawberry.”
Public health advocates have been warning for years about a spike in vaping among young Americans. The FDA reports that 19% of high school students and 4.7% of middle school students vaped in 2020 – a far higher share than students who smoked.
The vaping industry says its nicotine-delivering products help Americans transition off cigarettes and that the dessert-themed flavors are attractive to adults.
Recognizing the harm caused by youth smoking, Congress passed a law in 2009 giving the FDA new powers to regulate tobacco products. In 2016, the FDA decided that e-cigarettes qualified as tobacco products and it began reviewing authorization applications for millions of new vaping products.
The multi-billion-dollar industry says that the FDA changed its method for that review in the middle of the process, requiring companies to show, with randomized trials, that flavored products are more effective than tobacco-flavored products at helping smokers quit or cut back on cigarettes.
The 5th Circuit Court of Appeals sided with the industry in January, finding that officials had perpetrated a “regulatory switcheroo,” sending manufactures on a “wild goose chase” to get approval. Seven other appeals courts rejected similar challenges of the agency’s denials.
Alito wrote that the vaping companies “express frustration about the lack of clear prior notice regarding the type of scientific evidence that was essential for approval of an application, but we cannot agree with their argument that the FDA went back on any commitments made in the guidance it provided before ruling on respondents’ applications.”
“We thus conclude that (the companies) failed to show that the FDA changed its position with respect to the scientific evidence supporting premarket tobacco product applications,” he wrote for the court.
During the oral arguments in December, Justice Brett Kavanaugh pressed the parties on the practical effect of a decision either way.
“I’m curious what relief looks like in this case, because the companies can always reapply, correct?” Kavanaugh asked.
Curtis Gannon, an attorney with the Justice Department, agreed that they could.
“They can reapply without a fee,” he said. “And some other applicants have reapplied.”
But an attorney for the vaping industry countered that the FDA sometimes takes years to resolve applications.
“They can’t afford to wait that out,” said Eric Heyer, for the companies. “This was their one shot.”
This story has been updated with additional details Wednesday.
CNN’s Devan Cole contributed to this report.
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