By John Kruzel
WASHINGTON (Reuters) – A dispute over the U.S. Food and Drug Administration’s refusal to let two e-cigarette companies sell flavored vape products due to their health risk to youths goes before the U.S. Supreme Court on Monday in another case involving the power of regulatory agencies.
The FDA has appealed a lower court’s ruling that the agency did not follow proper legal procedures under a federal law called the Administrative Procedure Act when it denied applications by Triton Distribution and Vapetasia to sell their nicotine-containing products.
The case gives the Supreme Court a chance to further weaken federal regulatory agencies following major rulings in recent years limiting the authority of the bureaucracy that interprets laws, crafts rules and implements executive action.
“This case places the Supreme Court in a position of oversight over the FDA’s scientific decisions,” University of Utah law professor Daniel Aaron said. “Should it overrule the FDA, it could allow tens of thousands of e-cigarettes onto the market the FDA has determined are harmful to the public health, while continuing a trend of judges intruding on agencies’ scientific expertise.”
A 2016 FDA rule deemed e-cigarettes to be tobacco products that, like traditional cigarettes, are subject to agency review under a 2009 federal law called the Tobacco Control Act. That law requires manufacturers of e-cigarette products to apply for authorization to sell nicotine vaping devices and e-liquids.
Triton and Vapetasia filed FDA applications in 2020 for products with flavors such as sour grape, pink lemonade and crème brulee, and names including “Jimmy The Juice Man Peachy Strawberry” and “Suicide Bunny Mother’s Milk and Cookies” – offerings that critics call designed to appeal to children.
The FDA has approved only 34 flavored e-cigarette varieties, all tobacco or menthol flavored, and rejected applications for more than a million other products including e-liquids with flavors from candy to fruit to various desserts.
E-cigarettes in a range of flavors are still easily available despite being illegal. The FDA lacks its own litigating authority, meaning enforcement of its regulation requires cooperation from the U.S. Justice Department, which has generally been unwilling to crack down on unauthorized flavored vape products despite requests from the agency, Aaron said.
“These companies are flouting the law and are also using litigation to avoid FDA enforcement,” Aaron added.
To get FDA approval, e-cigarette companies must show that a product would be “appropriate for the protection of the public health,” meaning any health benefits – like helping traditional cigarette smokers transition to generally less-harmful vaping – must outweigh the risks of bringing the new product to market.
‘KNOWN AND SUBSTANTIAL RISK’
The FDA maintains it has not categorically banned flavored e-cigarette products. But companies seeking its approval face a particularly demanding health benefits-versus-risk legal test due to the FDA’s finding that flavored e-cigarettes pose a “known and substantial risk” to youths.
“The FDA has rejected all applications for flavored vaping products because such products simply cannot meet the public health standard because of their documented potential for creating new underage tobacco users,” said Mark Gottlieb, executive director of Northeastern University School of Law’s Public Health Advocacy Institute.
The FDA found that nearly one in five high school students and almost one in 20 middle school students used e-cigarettes in 2020, making e-cigarettes “the most widely used tobacco product among youth by far.” It found that youth users consistently cited flavor as a top reason for why they vape.
“Flavored e-cigarette use is highly prevalent among youth, which raises concerns about creating a new generation of adults addicted to nicotine,” Aaron said.
Ohio State University law and health policy professor Micah Berman said that in this case “the two sides have very different views about what happened.” The FDA, Berman said, maintains that it simply followed a law that was largely designed to protect minors.
Yet e-cigarette manufacturers have sought to portray the FDA as “an out-of-control agency that subjected them to a Kafka-esque series of constantly shifting and impossible-to-understand requirements,” Berman said.
Triton and Vapetasia in 2021 asked the New Orleans-based 5th U.S. Circuit Court of Appeals to review the FDA’s denial of their applications. The 5th Circuit in January ruled in favor of them, finding that the FDA had been arbitrary and capricious in violation of the Administrative Procedure Act.
The 5th Circuit ruling created a split with seven other federal appellate courts that have sided with the FDA in similar cases, and prompted the agency’s Supreme Court appeal.
The 5th Circuit’s ruling “seemed to strongly suggest that in rejecting the plaintiffs’ marketing applications, the FDA got the outcome wrong,” Berman said.
“It will be interesting to see whether the justices engage in similar second-guessing of how the FDA weighed the evidence,” Berman added.
(Reporting by John Kruzel; Editing by Will Dunham)
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