Gripum manufactured flavored e-liquids for use in open-system electronic nicotine delivery systems. They sought market authorization from the US Food and Drug Administration (FDA) to continue to make and sell their products. 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. Petitioner challenged the marketing denial order (MDO) against them and received a stay in 2021, but ultimately the Circuit Court denied their petition for review and upheld the FDA decision.
Why it matters for public health
Youth electronic smoking device use – commonly called “vaping” – significantly increased in 2016-2017. Innumerable 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 ESD 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 US Food and Drug Administration deemed electronic smoking devices and their accessories, including flavored e-liquids, to fall within the scope of their regulatory review in 2016, however allowed products then-on-market to remain available pending submission of Premarket Tobacco Product Applications (PMTAs). Continued inaction on enforcement and postponement of the PMTA deadline led to public health groups filing suit against FDA to compel regulatory action (See American Academy of Pediatrics et al. v. US Food and Drug Administration et al. (2018)). In 2020 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, FDA deemed that electronic cigarette (“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 been on-market for several years already, and in light of enforcement difficulties resulting therefrom FDA granted a grace period for on-market products 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 the majority of products (with the one-year between continuing the grace period).
Petitioner filed their PMTAs prior to the September 2020 deadline. One year later, FDA issued MDO to the petitioner, 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 in October, 2021, and received a stay pending review. Gripum argued that FDA acted arbitrarily and capriciously in its denial, claiming that 1) FDA failed to provide discernable standards for applicants to meet prior to its adjudication of the PMTAs; 2) FDA shifted its own review standards after receiving submissions; and 3) FDA applied general and arbitrary presumptions to Gripum’s submissions rather than undertake an individualized review.
The Court rejected Gripum’s claims in their entirety. Firstly, the Court noted that the standard FDA applied stems from the Tobacco Control Act itself and its requirement that FDA employ comparative analyses of tobacco products for public health benefits. Secondly, echoing the judgments made by other courts, the Court noted that FDA did not commit itself to accepting all “evidence” provided by the petitioner and regarding or weighting that evidence equally, let alone as sufficient substitutions for the forms of evidence (e.g., long-term studies) that FDA considered most valuable. Thirdly, the Court sided with 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 Court denied this motion.
Litigation Status (CLOSED)
Pending any further appeal for an en banc hearing and/or appeal to the Supreme Court of the United States, the petition is denied and FDA’s decision to issue an MDO to the Petitioner stands.