Supreme Court to hear arguments in case over FDA denials of flavored vapes

WASHINGTON (Gray DC) - On Monday, the Supreme Court will hear arguments in a case that challenges the Food and Drug Administration’s decision to deny applications for new flavored vaping products.

The agency has declined to approve over a million applications to sell the flavored vaping products in recent years, prompting legal challenges from several companies who argue that the FDA changed their approval process without fair notice.

The agency has maintained that flavored vapes pose a public health risk to young people and has said that they did not change their requirements.

The two vape manufacturers involved in the case before the high court are Triton Distribution and Vapetasia, who were denied applications to sell their flavored products.

“The FDA has said principally that the evidence to support this being good for the public health, and not intended to get more kids hooked, isn’t there. And so the FDA rejected these applications,” said Stephen Wermiel, a law professor at American University.

The 2009 Family Smoking Prevention and Tobacco Control Act requires FDA approval when tobacco product manufacturers want to sell new products. The act requires that the manufacturers show that the marketing of the new products be “appropriate for the protection of public health.” Specifically, the FDA has to consider both the “likelihood that existing users of tobacco products will stop using such products” and the “likelihood that those who do not use tobacco products will start using such products.”

The FDA has stated that flavored vapes, including products flavored to taste like candy, fruit, and desserts, “pose a serious, well-documented risk of attracting young people to the use of tobacco” and denied the applications for the new products.

“FDA denied marketing authorization because it found insufficient evidence that the benefits provided by the flavored e-cigarette products outweighed the risks they posed,” wrote Solicitor General Elizabeth Prelogar, in her petition to the Supreme Court.

Vape manufacturers have argued that their products can help tobacco users quit smoking cigarettes and have proposed plans to keep their products out of kids’ hands.

While several legal challenges to the FDA’s decisions have failed, Triton Distribution and Vapetasia were successful in the Court of Appeals for the Fifth Circuit.

“FDA started issuing mass marketing denials in the fall of 2021, and the industry stood up, fought. We have now gotten this position to the Supreme Court,” said Greg Troutman, an attorney who filed an amicus brief in the case for vaping industry stakeholders.

Judge Andrew Oldham wrote in the appeals court ruling that the FDA sent the vape manufacturers “on a wild goose chase.”

“First, the agency gave manufacturers detailed instructions for what information federal regulators needed to approve e-cigarette products“ he wrote. “Just as importantly, FDA gave manufacturers specific instructions on what regulators did not need. The agency said manufacturers' marketing plans would be “critical” to the success of their applications.“

The ruling went on to say that the companies spent millions to adhere to the FDA’s guidance but then later faced different testing requirements.

“Then, months after receiving hundreds of thousands of applications predicated on its instructions, FDA turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all one million flavored e-cigarette applications for failing to predict the agency’s volte face.”

Prelogar wrote in the FDA’s petition to the Supreme Court that the Fifth Circuit’s ruling was not correct.

“As seven courts of appeals have held, the agency has evaluated applications for authorization to market e-cigarette products in accordance with the standards set forth in the statute and the 2019 guidance.”

The question before the high court is whether the FDA’s denials were “arbitrary and capricious.”

Some public health and medical groups, like the Campaign for Tobacco Free Kids, have filed an amicus brief in the case in support of the FDA.

“We’re finding that every new generation of these e-cigarette products has more and more nicotine to it,” said Dennis Henigan, Vice President of Legal Affairs and Regulatory Affairs for the Campaign for Tobacco-Free Kids. “And so it becomes more and more addictive. So the threat grows and that’s why it’s then very important for the FDA to begin to take these products off the market, which has resulted in a decline in the prevalence of e-cigarette use amongst kids.”

Members of Congress have also filed briefs in the case, both in support of and against the FDA.

“Federal law is clear that a tobacco company must first prove its product has a public health benefit before it can be sold,” Sen. Dick Durbin (D-IL) said in a statement. “Since tobacco companies peddling ‘peachy strawberry’ and ‘milk and cookies’ flavored e-cigarettes could never meet that requirement, they are now turning to the courts in a desperate attempt to avoid commonsense regulation.”

In a brief filed on behalf of Sen. Tedd Budd (R-NC), Sen. Roger Marshall (R-KS), Sen. Thom Tillis (R-NC). Sen. Tommy Tuberville (R-AL) and other lawmakers, they argue that the FDA should not be regulating vaping products.

“Congress, not the FDA, should determine the major question of whether e-cigarette devices should be banned...” the brief said. “After claiming that authority, it has then spent years putting the manufactures of such devices through a long elaborate review process where they were directly informed what materials were and were not required of their premarket tobacco product application (“PMTA”). Only after that process had concluded did the FDA then surprise manufacturers with totally new, arbitrary, and extra-statutory requirements for these devices, a new requirement that imposed a de facto ban. It had no authority to do so.”