Synopsis

Prohibition Juice Co, and the other Petitioners whose cases were consolidated with this one, manufactured flavored nicotine-containing e-liquids for use in open-system e-cigarette devises. 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. 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 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.

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, 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).

Proceedings

Petitioner submitted its PMTA to FDA in September, 2020, seeking marketing authorization for flavored e-liquid products which included the flavors “Boozehound” and “Sweet Thang” (as was true for the petitioners in the consolidated cases, who sought marketing authorization for their flavored e-liquid products). FDA issued its MDOs to the Petitioner in September, 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. Petitioner challenged the FDA decision on the grounds that 1) FDA did not have authority to require comparative efficacy findings, and 2) FDA acted arbitrarily and capriciously.

The Circuit Court was unmoved by the Petitioner’s claims. On the question of authority the Court pointed to the language of the Tobacco Control Act which “expressly instructs the FDA to consider evidence regarding just the comparison that the manufacturers say the FDA lacks statutory authority to make.” Furthermore, FDA’s consideration of initiation and cessation for tobacco products is required by the Tobacco Control Act and cannot be said to deviate from their statutory authority to assess health risks, with the Court surmising that FDA’s directive was and is to determine whether a product is “appropriate for the protection of the public health” – the generally encompassing Public Health Standard.

The Circuit court further addressed the “surprise switcheroo” challenge that FDA deviated from its 2019 guidance to industry document in requiring rigorous research data. The Court noted that the statute – not the guidance document – provides the basis for what evidence FDA requires in making a marketing determination, and even with the guidance material FDA’s evidentiary requirements were spelled out plainly; that FDA might, or could, or may, consider evidence in addition to rigorous research data is conditional and not substitutive. The Court finally disregarded Petitioner’s assertion that FDA’s not reviewing its youth access plan favorably was a fatal flaw in FDA’s processing, holding that even if FDA made an error that the error was harmless to the overall analysis of the Petitioner’s PMTA.

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 Petitioner stands.

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