Supreme Court declines to hear case challenging FDA authority to reject flavored e-cigarettes

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A woman smokes an E-Cigarette at Digital Ciggz in San Rafael, California.

Justin Sullivan | Getty Images

The Supreme Court on Tuesday declined to hear arguments in a case challenging the Food and Drug Administration’s authority to reject approvals of flavored electronic cigarettes. The case is part of a series of challenges to FDA regulation of the vaping market, which has grown into an $8.2billion industry in less than 10 years.

The 4th Circuit U.S. Court of Appeals in December ruled that the FDA has the power to deny applications for flavored e-cigarette products because of its mandate to protect public health by discouraging younger people from smoking.

The lower court ruling rebuffed an appeal by Avail Vapor, a vape retailer, which argues that the FDA unfairly denied its product applications based on requirements the agency “secretly” changed without notifying companies.

Avail’s attorney, Eric Heyer, told CNBC on Tuesday that the company is “disappointed that the Supreme Court declined to review the flawed process by which FDA issued its marketing denial orders to Avail without adequate prior notice of the specific longitudinal comparative efficacy study requirements the agency ultimately imposed.”

The FDA issues marketing denial orders to reject product applications.

A spokesperson for the FDA did not immediately respond to a request for comment on the Supreme Court’s decision.

In 2016, the FDA determined that e-cigarettes were subject to its regulation, like traditional tobacco products. E-cigarettes, or handheld devices that inhale a vapor containing nicotine, flavoring, and other chemicals, are used to smoke. The FDA rejected more than 1 million e-cigarette applications by the March deadline.

The FDA in March said nearly seven million applications were submitted by that deadline, but the agency has rejected more than 1 million of them.

Why did the FDA reject the e-cigarette applications?

The case is related to the FDA’s 2021 decision to reject all of Avail Vapor’s applications for its fruit- and dessert-flavored e-cigarettes.

The FDA said Avail did not present long-term studies demonstrating that its sweet-flavored vapes were more effective at helping adult smokers quit than tobacco-flavored e-cigarettes.

The agency said those studies are necessary to demonstrate that the benefits of Avail’s products to adults outweigh their risks to youth. According to the FDA, children, teens, and young adults prefer ecigarettes that taste like sweet treats. The company also detailed its marketing strategies, such as age verification online, to prevent minors from using its flavored electronic cigarettes. In its appeal before the 4th Circuit, Avail argued that FDA did not say it would require long-term studies to compare the company’s fruit- and dessert-flavored electronic cigarettes with tobacco-flavored vapes. “The FDA claims Avail and other retail outlets should have known what the FDA was going to look for. Heyer said that virtually no one in the industry was aware of this. The FDA had five-years to inform applicants of this fact, but they didn’t. “

Avail also argued that the FDA was obligated to consider the marketing plan included in its applications.

What are implications for vaping industry?

But 4th Circuit Judge J. Harvie Wilkinson wrote in December that Avail “encourages us to neglect forest for trees” by focusing on procedural objections rather than the FDA’s mandate

to “ensure that another generation of Americans does not become addicted nicotine and tobacco products. “

Avail also argued that the FDA was obligated to consider the marketing plan included in its applications.

What are the implications for the vaping industry?

But 4th Circuit Judge J. Harvie Wilkinson wrote in December that Avail “encourages us to neglect the forest for the trees” by focusing on procedural objections rather than the FDA’s mandate

to “ensure that another generation of Americans does not become addicted to nicotine and tobacco products. Wilkinson stated that the FDA rejected the applications because they lacked specific long-term research. He said the agency followed its mandate by requiring strong, product-specific evidence to evaluate the benefit of new e-cigarette products to adults, which Avail did not provide.

Avail exited the retail business after selling all of its 100 brick-and-mortar stores in October 2021, a month after the FDA rejected its applications. JUUL advertising outside a vape shot in New York.

Melissa Fares | Reuters

Avail is not the only company to challenge application rejections from the FDA.

Last year, Juul Labs lost in its appeal of the FDA’s ban on its vaping products. The e-cigarette giant, which slashed nearly a third of its workforce in a bid to avoid bankruptcy, said the FDA conducted an incorrect and incomplete assessment of its data.

Upon review of the appeal and a temporary reprieve that allowed some of Juul’s products to come back to market, the agency determined Juul’s products still pose a risk to public health.

However, in some cases, the FDA has rescinded, or partially rescinded, rejections following the appeal process. To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices.

Efforts to restrict e-cigarette flavors favored by teens may have fallen flat as new brands hit the market. Between January 2020 and December 20,22, e-cigarette sales increased by nearly 47%. Many of the most popular disposable e-cigarettes available on the market do not meet FDA standards and are illegal.