US Court Upholds FDA's Denial of Avail Vapor's PMTA Application

On Monday, the Fourth Circuit Court of Appeals in the United States issued an opinion supporting the decision made by the Food and Drug Administration (FDA) to deny Avail Vapor LLC's application to sell its flavored electronic cigarettes and to reject Avail's review request.

According to this opinion, the Tobacco Control Act (TCA) requires manufacturers of new tobacco products to obtain FDA authorization through a pre-market tobacco product application (PMTA) before selling these products. The TCA further requires the FDA to determine whether the marketing of new tobacco products is "appropriate for protecting public health" in order to authorize PMTA.

Avail Vapor is a company that sells electronic cigarette products regulated by the FDA through TCA. This statement indicates that in the constantly developing regulatory framework for electronic cigarettes, Avail submitted a PMTA to the FDA for approval on September 8, 2020.

The court stated that in 2019, the FDA issued new guidelines on the premarket tobacco product application (PMTA) for e-cigarettes to address the "youth e-cigarette epidemic." Specifically, the FDA stated that enforcement decisions would be made based on specific circumstances and that they would continue to evaluate new information to address the growing problem of underage use of flavored e-cigarettes. Additionally, manufacturers of existing e-cigarette tobacco products must submit a PMTA.

According to the opinion, Avail will submit its PMTA for FDA approval before the specified deadline. The court noted that Avail's PMTA focuses on various fruit and dessert-flavored electronic cigarettes. Additionally, Avail has provided a marketing plan that outlines measures to prevent underage use, including giving flavors unusual names, age-restricted physical stores, and sales point systems.

However, on September 15, 2021, the FDA rejected Avail's PMTA and issued a marketing refusal order for its products. In the refusal order, the FDA stated that Avail's products pose a serious risk to adolescents and do not have sufficient offsetting benefits for adults.

Subsequently, Avail filed an administrative appeal against the order, but on February 23, 2022, the FDA upheld its decision and reiterated its concerns for minors' safety. Avail promptly requested that the Fourth Circuit Court review the FDA's refusal order, arguing that it imposed arbitrary standards on the types of information manufacturers must provide in PMTAs and that the FDA's imposition of these standards exceeded its statutory authority.

In a unanimous decision, the court found that the Tobacco Control Act (TCA) grants the FDA broad statutory authority to determine whether the marketing of a new tobacco product is "appropriate for the protection of public health" based on all evidence received. Additionally, the court stated that Avail's arguments and restrictions "completely contradict" the requirements of the FDA under the TCA. Therefore, the court found that the FDA's standards for evaluating information during its PMTA review were fully within its statutory authority.

Furthermore, the court found that the FDA's denial of Avail's PMTA was "hardly arbitrary," and that it appropriately evaluated the evolving science and ever-changing market when assessing the significant risks of teenage addiction to flavored e-cigarettes. Therefore, the court confirmed the FDA's rejection order and denied Avail's request for a review.

Avail is being represented by Thompson Hine LLP.