Wages and White Lion, and Vapetasia LLC, manufactured flavored nicotine-containing e-liquids for use in open-system e-cigarette devices. 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 petitioners’ respective 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. Petitioners 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 decisions.
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).
Petitioners filed their PMTAs on September 9, 2020, seeking approval for flavors that included sour grape, pink lemonade, milk and cookies, concepts like “Suicide Bunny Bunny Season.” FDA issued MDOs to petitioners on September 14 and 16, 2021, citing among its reasons that the Petitioners did not provide evidence demonstrating the 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. The cases brought by the Petitioners were consolidated following their filings and request for stays, with the principle argument from the Petitioners being that the FDA lacked authority to impose the comparative efficacy requirement and, thusly and additionally, acted arbitrarily and capriciously.
The Circuit Court did not mince words in its rejection of the Petitioners’ arguments. On the first claim that 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 applicant to show their products present less risk than other tobacco products – a comparison – and 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 Circuit 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 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 (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 MDOs to the Petitioners stands.