WASHINGTON (Gray DC) – On Monday, the Supreme Court will hear arguments in a case that challenges the Food and Drug Administration’s authority to approve or deny new vaping products.
The agency has declined to approve new flavored vaping products in recent years, prompting legal challenges from several companies who argue that the FDA unfairly changed their approval process.
The agency has maintained that flavored vapes pose a public health risk to young people.
“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 FDA has stated that flavored vapes are enticing to young users, especially those that taste like candy, fruit and desserts.
The agency has been trying to combat the use of vapes which have become the most commonly used tobacco product among youth.
“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, which filed an amicus brief for the case. “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.”
Vape companies have said for years 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 decision have failed, two companies were successful in a federal appeals court. It found that the regulatory agency failed to correctly assess the companies’ requests and changed its authorization requirements without fair notice.
“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.
Now the high court decide if the FDA’s denials were “arbitrary and capricious.”
Sixteen members of Congress also filed an amicus brief in the case, in support of 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. But make no mistake, if the Supreme Court fails to reverse the Fifth Circuit’s decision, it would be a gift to Big Tobacco and unleash a wave of youth tobacco addiction.”
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