On Monday, the Fourth Circuit issued an opinion upholding the Food & Drug Administration’s (FDA) decision denying Avail Vapor LLC’s application to market its flavored electronic cigarettes and denying Avail’s petition for review.
According to the opinion, the Tobacco Control Act (TCA) requires manufacturers of new tobacco products to receive authorization by the FDA through the Premarket Tobacco Product Application (PMTA) prior to marketing those products. The TCA further requires the FDA to determine if the new tobacco products marketing is “appropriate for the protection of the public health” in order to authorize the PMTA.
Avail Vapor is a company that sells electronic cigarette products which are regulated by the FDA through the TCA. The opinion states Avail submitted PMTAs to the FDA for approval on September 8, 2020 amidst an evolving regulatory framework for electronic cigarettes.
The court states, in 2019, the FDA issued a new guidance on PMTAs for electronic cigarettes to address the “youth vaping epidemic.” Specifically, the FDA stated it would make enforcement decisions on a case-by-case basis and that it would continue to evaluate new information to properly address the increased use of flavored electronic cigarettes by minors. Further, manufacturers of electric tobacco products that were already on the market were required to submit a PMTA.
According to the opinion, Avail submitted its PMTAs to the FDA for approval right before the imposed deadline. The Court states Avail’s PMTAs focused on various fruit- and dessert-flavored electronic cigarette liquids. Additionally, Avail provided a marketing plan outlining measures to prevent underaged use including giving the flavors nondescript names, age-gated brick-and-mortar stores and point of sale system.
However, on September 15, 2021, the FDA rejected Avail’s PMTAs and issued a marketing denial order for its products. In the denial order, the FDA stated Avail’s products posed a serious risk to youth without enough offsetting benefits to adults.
Subsequently, Avail administratively appealed the order, but on February 23, 2022, the FDA affirmed its decision and reiterated its concerns about the risks to minors. Avail timely petitioned the Fourth Circuit for review of the FDA’s denial order arguing it arbitrarily imposed standards for the type of information manufacturers must provide in PMTAs and that the FDA’s imposition of those standards exceeded its statutory authority.
In the unanimous opinion, the court held the TCA grants the FDA a broad statutory mandate to determine from the totality of the evidence before it whether marketing of new tobacco products is “appropriate for the protection of the public health.” Further, the court stated Avail’s arguments and imposed restrictions “simply run counter to” what is required by the FDA under the TCA. Therefore, the court held that the FDA was squarely within its statutory authority when it imposed standards for evaluating information during its PMTA review.
Further, the court held that the FDA’s denial of Avail’s PMTA “was hardly arbitrary” and that it properly evaluated evolving science and an ever changing market while evaluating the substantial risk of youth addiction from flavored electronic cigarettes. Accordingly, the court affirmed the FDA’s denial order and denied Avail’s petition for review.
Avail is represented by Thompson Hine LLP.
