Synopsis

Wages and White Lion Investments and Vapetasia manufactured flavored nicotine-containing e-liquids for use in open-system 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 2021, but ultimately the 5th Circuit denied their petition for review and upheld the FDA decisions. An en banc rehearing was granted on January 19, 2022.

Why it matters for public health

Youth electronic smoking device (ESD) use—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 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 FDA deemed ESDs 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 Premarket Tobacco Product Applications (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 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 most products.

Proceedings

Petitioners filed their PMTAs on September 9, 2020, seeking approval for flavors that included sour grape, pink lemonade, milk and cookies, and concept flavors like “Suicide Bunny Bunny Season.” The FDA issued MDOs to petitioners on September 14 and 16, 2021, citing among its reasons that the petitioners did not provide evidence demonstrating that flavored products provide a benefit to adult users that outweigh the risks to youth and that such evidence could have included a comparative efficacy finding that the flavored products provided such benefits over tobacco-flavored products. Petitioners filed their petitions in October, 2021, and the cases were consolidated. Their principal argument was that the FDA lacked authority to impose the comparative efficacy requirement and thus acted arbitrarily and capriciously.

The 5th Circuit did not mince words in its rejection of the petitioners’ arguments. On the first claim that the FDA acted without authorization, the court stated: “Petitioners are blatantly wrong—the TCA [Tobacco Control Act] authorizes FDA to consider comparative cessation evidence, if not expressly then impliedly.” The court pointed to express language in the TCA that required applicants to show their products present less risk than other tobacco products—a comparison, that FDA is required to consider the information submitted to them and, so, must consider that comparison as part of its review. The Court further looked to express language requiring FDA to consider increased or decreased likelihood that users will stop using tobacco products in relation to the marketing of the product under consideration, reasoning that such increased or decrease likelihood is a comparison to the status quo.

The Court also did not feel persuaded by the argument that FDA acted arbitrarily and capriciously. Noting that where FDA acts reasonably the court is beholden to defer—whether they individually agree or not with the decision—the court found that the FDA’s dismissal of a small study provided by one of the petitioners; including of facts and evidence which emerged post-2019 with respect to youth consumption of flavored products; requiring evidence that the petitioners did not provide; and failure to favorably regard the petitioners’ marketing plans, did not rise to arbitrary and capricious decision-making.

Litigation Status (OPEN)

Wages and White Lion and Vapetasia petitioned the 5th Circuit for an en banc rehearing, which was granted on January 19, 2022. The previous opinion has been vacated.