On Monday, a unanimous panel of the United States Fourth Circuit Court of Appeals ruled that the FDA acted within its authority when dealing with the "difficult task of ensuring that the next generation of Americans will not become addicted to nicotine and tobacco products," and rejected an appeal from Virginia-based Avail Vapor LLC.
Eric Heyer, attorney for Avail at Thompson Hine, declined to comment. The FDA did not immediately respond to a request for comment.
Electronic cigarettes release nicotine through the vaporization of liquid, rather than burning tobacco. In 2016, the FDA determined that e-cigarettes were to be regulated in the same manner as traditional tobacco products, and required manufacturers to apply for approval of electronic cigarettes and related products such as liquid by 2020.
Avail was once a well-known retailer of flavored electronic cigarette oil. In 2020, the company sought approval for its products and told the FDA that they could help smokers quit by switching to e-cigarettes. Avail claimed that it had implemented measures such as age verification for online sales and limited distribution in specialty stores to ensure that its products were not sold to minors.
The FDA has rejected the application in 2021, stating that the company did not submit long-term studies to support its claim that its products (including fruit flavors) are more effective in helping smokers quit than tobacco-flavored liquids. The agency also noted that the product's appeal to minors is minimal. It refused to consider the company's plan to restrict sales.
On August 29, 2020, a sign was visible outside the headquarters of the Food and Drug Administration (FDA) in White Oak City, Maryland, United States. REUTERS/Andrew Kelly.
Avail lost in its administrative appeal and then petitioned the Fourth Circuit Court of Appeals to overturn the ruling. The company argued that the FDA did not indicate a need for long-term guidance for e-cigarette companies in 2019 and later surprised them with a "switch." It also stated that the agency has an obligation to consider sales plans.
On Monday, Circuit Judge J. Harvie Wilkinson wrote that Avail's authorization through procedural opposition rather than FDA protection of public health "encourages us to ignore the forest for the trees.
Judges Diana Gribbon Motz and Albert Diaz have joined the ranks of Wilkinson.
The FDA has rejected over 55,000 applications from e-cigarette products. The DC Circuit, the Third Circuit Court, and the Seventh Circuit Court had previously upheld these rejections.
James Xu, the founder of Avail, has informed the Richmond Times-Dispatch in January 2022 that the company is shutting down due to the failure to obtain approval from the FDA. However, the company is hopeful that they can eventually start anew.
The case referred to as Avail Vapor LLC v. U.S. Food and Drug Administration and the Fourth Circuit Court of Appeals, case number 21-2077.
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