By John Kruzel

WASHINGTON (Reuters) – A dispute over the U.S. Food and Drug Administration’s refusal to allow two e-cigarette companies to sell flavored e-cigarette products because of their health risks to teenagers will go before the Supreme Court on Monday USA is negotiating. Another case concerns the powers of supervisory authorities.

The FDA is appealing a lower court’s ruling that the agency failed to follow proper legal procedures under a federal law called the Administrative Procedure Act in rejecting applications from Triton Distribution and Vapetasia to sell their nicotine-containing products.

The case gives the Supreme Court a chance to further weaken federal regulators after key decisions in recent years that limited the authority of the bureaucracy that interprets laws, makes rules and implements executive actions.

“This case puts the Supreme Court in a position to oversee the FDA’s scientific decisions,” said Daniel Aaron, a law professor at the University of Utah. “Should it overrule the FDA, it could put on the market tens of thousands of e-cigarettes that the FDA has determined are harmful to public health, while continuing the trend of judges encroaching on the authorities’ scientific expertise intervention.”

A 2016 FDA rule says e-cigarettes are tobacco products that, like traditional cigarettes, are subject to regulatory review under a 2009 federal law called the Tobacco Control Act. This law requires manufacturers of e-cigarette products to apply for a license to sell nicotine vapor devices and e-liquids.

Triton and Vapetasia filed applications with the FDA in 2020 for products with flavors like sour grape, pink lemonade and crème brûlée, and names like “Jimmy The Juice Man Peachy Strawberry” and “Suicide Bunny Mother’s Milk and Cookies” – offerings that critics described as Designed to appeal to children.

The FDA has approved just 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 ranging from candy to fruit to various desserts.

E-cigarettes in various flavors are still readily available despite their illegality. The FDA lacks its own litigation authority, meaning enforcing its regulations requires cooperation with the U.S. Department of Justice, which has generally been unwilling to take action against unauthorized flavored e-cigarette products despite requests from the agency, Aaron said.

“These companies ignore the law and also use litigation to avoid FDA enforcement,” Aaron added.

To receive FDA approval, e-cigarette companies must demonstrate that a product is “suitable for protecting the public health,” meaning any health benefits — such as helping traditional cigarette smokers switch to generally less harmful ones Vaping – the risks must outweigh the risks of bringing the new product onto the market.

“KNOWN AND SIGNIFICANT RISK”

The FDA maintains it has not categorically banned flavored e-cigarette products. However, companies seeking approval face a particularly challenging legal health benefit-risk test because the FDA has determined that flavored e-cigarettes pose a “known and significant risk” to youth.

“The FDA has rejected all applications for flavored e-cigarette products because such products simply cannot meet public health standards due to their documented potential to create new underage tobacco users,” said Mark Gottlieb, executive director of the Public Health Advocacy Institute Northeastern University School of Law.

The FDA found that nearly one in five high school students and nearly one in 20 middle school students used e-cigarettes in 2020, making e-cigarettes “by far the most commonly used tobacco product among youth.” It found that teen users consistently cited taste as the main reason they vape.

“Use of flavored e-cigarettes is widespread among youth, raising concerns that a new generation of nicotine-addicted adults could emerge,” Aaron said.

Micah Berman, a professor of law and health policy at Ohio State University, said that in this case, “the two sides have very different views about what happened.” The FDA, Berman said, insists that it was simply following a law that was largely aimed at protecting minors.

Still, e-cigarette makers have tried to portray the FDA as “an out-of-control agency that has subjected them to a Kafka-like set of ever-changing and incomprehensible requirements,” Berman said.

In 2021, Triton and Vapetasia asked the 5th U.S. Circuit Court of Appeals, based in New Orleans, to review the FDA’s rejection of their applications. The 5th Circuit ruled in their favor in January, finding that the FDA had arbitrarily and capriciously violated the Administrative Procedure Act.

The 5th Circuit’s ruling created a split with seven other federal appeals courts that had sided with the FDA in similar cases and prompted the agency to appeal to the Supreme Court.

The 5th Circuit’s ruling “strongly appeared to suggest that the FDA reached an erroneous conclusion in rejecting plaintiffs’ marketing applications,” Berman said.

“It will be interesting to see whether the justices apply similar considerations to how the FDA weighed the evidence,” Berman added.

(Reporting by John Kruzel; Editing by Will Dunham)