Gripum manufactured flavored e-liquids for use in open-system electronic nicotine delivery systems. It sought market authorization from the FDA to continue to make and sell its products. The FDA denied the request by finding that the petitioner’s 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. The petitioner challenged the marketing denial order (MDO) against it and received a stay in 2021, but the Seventh Circuit ultimately denied their petition for review and upheld the FDA decision.
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 e-cigarettes. 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 et al. v. US Food and Drug Administration et al. (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.
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.
The petitioner filed its PMTAs prior to the September 2020 deadline. One year later, the FDA issued the petitioner an MDO, stating that “the new products … lack sufficient evidence to demonstrate that the marketing of these products is appropriate for the protection of public health.” Gripum filed its case with the Seventh Circuit in October of 2021 and received a stay pending review. Gripum argued that the FDA acted arbitrarily and capriciously in its denial, claiming that 1) the FDA failed to provide discernable standards for applicants to meet prior to its adjudication of the PMTAs; 2) the FDA shifted its own review standards after receiving submissions; and 3) the FDA applied general and arbitrary presumptions to Gripum’s submissions rather than undertake an individualized review.
The Seventh Circuit rejected Gripum’s claims in their entirety. First, the court noted that the standard that the FDA applied stems from the Tobacco Control Act itself and its requirement that the FDA employ comparative analyses of tobacco products for public health benefits. Second, echoing the judgments made by other courts, the court noted that the FDA did not commit itself to accepting all “evidence” provided by the petitioner and regarding or weighing that evidence equally, let alone as sufficient substitutions for the forms of evidence (e.g., long-term studies) that the FDA considered most valuable. Third, the court sided with the FDA in its determination that Gripum did not sufficiently individualize its own products when it failed to show that its e-liquids were relatively likely to switch some adult combustible tobacco users to noncombustible electronic smoking devices, while also being unlikely to contribute to youth initiation and tobacco product uptake.
Relatedly, the court noted that Gripum filed a second motion to reopen the administrative record and add a memorandum to the record. For administrative reasons (the motion coming exceptionally late in proceedings) as well as substantive ones (Gripum’s second motion does not add any evidence or identify a flaw in the presumption of regularity in certifying the administrative record), the Seventh Circuit denied this motion.
Litigation Status (OPEN)
On December 1, 2022, Gripum sought review from the Supreme Court. Justice Barrett, who oversees the Seventh Circuit, granted an extension to file a petition for a writ of certiorari through January 26, 2023, and Gripum filed its petition on that date. The FDA must file a response to Gripum’s petition by March 1, 2023. The FDA’s decision to issue an MDO to the petitioner stands unless the Supreme Court rules otherwise or grants an injunction.