Synopsis
Bidi Vapor, along with the consolidated plaintiffs Diamond Vapor, Johnny Copper, Vapor Unlimited, Union Street Brands, and Pop Vapor, manufactured flavored nicotine-containing e-liquids for use in e-cigarette devices. They sought market authorization from the FDA to continue to make and sell their products. The FDA denied their request, finding that their premarket tobacco product applications (PMTAs) did not offer reliable and robust evidence to overcome the risks of youth addiction while also showing a benefit to adult smokers from continued marketing. These petitioners challenged the marketing denial order (MDO) against them and received a stay in 2022. The Eleventh Circuit ruled in favor of the petitioners on August 24, 2022, stating that the FDA acted arbitrarily and capriciously in not considering the companies’ marketing and sales strategies, remanding the case to the FDA to reevaluate.
Why it matters for public health
Youth use of e-cigarettes—also known as use of an electronic smoking device (ESD) or electronic nicotine device system (ENDS), and commonly called vaping—significantly increased in 2016–2017. Numerous providers of flavored e-liquids emerged with products that could work with electronic nicotine delivery devices. The 2019–2020 rise in lung injuries resulting from e-cigarette use—known as E-cigarette or Vaping Product Use-Associated Lung Injury or “EVALI”—brought renewed attention to the youth vaping epidemic and may have spurred regulatory oversight.
The FDA deemed e-cigarettes and their accessories, including flavored e-liquids, to fall within the scope of their regulatory review in 2016, but it allowed products then on the market to remain available pending submission of PMTAs. Continued inaction on enforcement and postponement of the PMTA deadline led to public health groups filing suit against the FDA to compel regulatory action (see American Academy of Pediatrics v. FDA (2018)). In 2020, the FDA closed the window for all on-market products to have a PMTA submitted and began issuing authorization orders and MDOs a year later.
Background
The Tobacco Control Act requires “new tobacco products,” defined as those that were commercially marketed after February 15, 2007, to go through a premarket review process and receive affirmative marketing orders before being sold in the U.S. In 2016, the FDA deemed that e-cigarettes and e-liquids were within its regulatory jurisdiction under the Tobacco Control Act, which amended the Food, Drug, and Cosmetic Act. E-cigarettes and e-liquids had already been on the market for several years, and in light of enforcement difficulties resulting therefrom, the FDA granted a grace period for products on the market before manufacturers would need to submit PMTAs. Following some parallel administrative and court action, the deadline for PMTA submissions of this type was set for September 9, 2020, with final decisions issued by September 9, 2021 for most products.
Proceedings
The petitioners filed their PMTAs prior to the September 2020 deadline. One year later, the FDA issued MDOs to the petitioners, with these MDOs stating that the “key basis for [the FDA's] de-termination” was that “[a]ll of [the applications] lack[ed] sufficient evidence demonstrating that [the] flavored [products] will provide a benefit to adult users that would be adequate to outweigh the risks to youth.” The cases brought by the petitioners were consolidated following their filings and request for stays. Their main argument was that the FDA lacked authority to impose the comparative efficacy requirement and thus acted arbitrarily and capriciously.
In August of 2022, the Eleventh Circuit panel agreed with the petitioners, in contrast to the conclusions reached by other circuits. The majority determined that the FDA had led manufacturers to believe that marketing and sales plans were an important part of the PMTA review, noting that the FDA’s own materials state that such materials are “directly relevant,” “critical,” and “necessary” to make a marketing determination. It concluded that not reviewing them when provided constituted an unjustifiable action, particularly when the FDA’s rationale for doing so is that the agency has “experience” and therefore did not need to analyze the plans that manufacturers included in their materials, based on the FDA’s experience assessing similar plans. The majority concluded that the FDA did not have discretion to disregard but rather must consider whatever is submitted to it. Contrasting with other courts, the majority considered this to be not a “harmless error” on the FDA’s part. The majority noted that the court’s decision was procedural, and that the FDA may reach the same conclusion after reviewing the marketing plans.
Litigation Status (CLOSED)
The decision in the Eleventh Circuit stands, as the FDA has not appealed. The dissent noted, however, that it is unlikely that the FDA would have appealed; the agency can, and the dissent contends that it must, simply re-review the marketing and sales plans provided by the petitioners and reissue its MDOs. The petitioners, for their part, may then re-file and seek review again. This case may be closed pending any appeals, but the conflict and parties involved may end up substantively revisiting issues as a new filing in the future.