- The Supreme Court declined to hear arguments in a case challenging the Food and Drug Administration’s authority to deny approval of flavored electronic cigarettes.
- The Avail Vapor case is one of several challenges to the FDA’s regulation of the vaping industry.
- E-cigarettes have created a market worth $8.2 billion and have made a new generation addicted to nicotine.
A woman smokes an e-cigarette at Digital Cigs in San Rafael, California.Thank you for reading this post, don't forget to subscribe!
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 deny approval of flavored electronic cigarettes.
The case is one of several challenges to the FDA’s regulation of the vaping industry, which has left members of a new generation addicted to nicotine, and has grown to an $8.2 billion market in less than a decade.
In December the Fourth Circuit US Court of Appeals ruled that the FDA has the power to deny applications for flavored e-cigarette products to protect public health by discouraging young people from smoking.
The lower court ruling rejected an appeal by vape retailer Evel Vapor, which had argued that the FDA unfairly rejected its product applications based on requirements the agency “secretly” changed without notifying the companies. done.
Avail’s attorney, Eric Hare, told CNBC on Tuesday that the company is “disappointed that the Supreme Court declined to review the flawed process by which the FDA granted Avail its approval without adequate prior notice of the specific longitudinal comparative efficacy study requirements.” Marketing rejection orders issued. Ultimately imposed.”
The FDA issues marketing rejection orders to reject product applications.
An FDA spokesperson 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 are handheld devices used to inhale vapor, which typically contains nicotine, flavorings, and other chemicals.
The agency gave companies until September 2020 to submit applications for approval for each of their vape products, even if they were already on the market.
In March the FDA said nearly seven million applications had been submitted by that deadline, but the agency had rejected more than 1 million of them.
The case relates to the FDA’s 2021 decision to reject all of Avail Vapor’s applications for fruit- and dessert-flavored e-cigarettes.
The FDA said Avail did not submit long-term studies showing that its sweet-flavored vapes were more effective in helping adult smokers quit smoking than tobacco-flavored e-cigarettes.
The agency said these studies are needed to demonstrate that the benefits of Avel’s products for adults outweigh their risks for youth. According to the FDA, children, teens and young adults are more attracted to e-cigarettes that mimic the taste of sugary treats.
Avail’s applications included four studies that surveyed patients on the safety and usefulness of some of the company’s products and e-cigarettes, but that research did not compare tobacco-flavored vapes. The company also outlined its marketing measures, including age verification for online sales, designed to deter underage use of its flavored e-cigarettes.
Ewell had argued in his appeal to the Fourth Circuit that the FDA did not say it would need to see long-term studies comparing the company’s fruit- and dessert-flavored e-cigarettes with tobacco-flavored vapes.
“The FDA says Avel and other retailers should have known what they were going to be looking for. Really no one in the industry knew,” Hair told CNBC.
“The lack of comparative efficacy studies was one of the main reasons why the FDA rejected these applications,” he said. “The FDA had five years to tell applicants this and they never did. Not said a word.”
Ewell also argued that the FDA was obligated to consider the marketing plan involved in its applications.
But Fourth Circuit Judge J. Harvey Wilkinson wrote in December that Ewell “encourages us to ignore the forest for the trees” by focusing on procedural objections rather than the FDA’s order. “To ensure that another generation of Americans does not become addicted to nicotine and tobacco products.”
Wilkinson said the FDA did not reject the applications due to the lack of specific long-term studies. He said the agency followed its order by requiring strong, product-specific evidence to evaluate the benefits of new e-cigarette products for adults, which Evel did not provide.
Avail exited the retail business in October 2021 after selling all 100 of its brick-and-mortar stores, a month after the FDA rejected its applications.
Advertisement for JUUL outside a vape shot in New York.
Melissa Fairs | reuters
Avel is not the only company to challenge the application rejection from the FDA.
Last year, Juul Labs lost an appeal of the FDA’s ban on its vaping products. The e-cigarette giant, which has cut about a third of its workforce to avoid bankruptcy, said the FDA had made an inaccurate and incomplete assessment of its data.
After an appeal review and a temporary reprieve that allowed some of Juul’s products to return to the market, the agency determined that Juul’s products still pose a threat to public health.
However, in some cases, the FDA has rescinded, or partially rescinded, rejections after an appeals process. To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices.
Efforts to restrict e-cigarette flavors preferred by teens may have failed as new brands entered the market. E-cigarette unit sales grew nearly 47% between January 2020 and December 2022. Many popular brands of disposable e-cigarettes on the market are not FDA-approved and are illegal.