Synopsis

Prohibition Juice and other petitioners whose cases were consolidated with this one 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 the request, 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. The petitioners challenged the FDA’s marketing denial order (MDO) against them and received a stay in 2021, but the D.C. Circuit ultimately denied their petition for review and upheld the FDA’s decisions.

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 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 (TCA) 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 TCA, 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.

Proceedings

Prohibition Juice submitted its PMTA to the FDA in September of 2020, seeking marketing authorization for flavored e-liquid products that included flavors like “Boozehound” and “Sweet Thang” (other petitioners in the consolidated cases also sought marketing authorization for their flavored e-liquid products). The FDA issued its MDOs to Prohibition Juice and other petitioners in September of 2021, citing among its reasons that the petitioners did not provide evidence demonstrating that their 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. Prohibition Juice challenged the FDA’s decision on the grounds that 1) the FDA did not have authority to require comparative efficacy findings, and 2) the FDA acted arbitrarily and capriciously.

The D.C. Circuit was unmoved by the Prohibition Juice’s claims. On the question of authority, the court pointed to the language of the TCA, which “expressly instructs the FDA to consider evidence regarding just the comparison that the manufacturers say the FDA lacks statutory authority to make.” Furthermore, the FDA’s consideration of initiation and cessation for tobacco products is required by the TCA and cannot be said to deviate from its statutory authority to assess health risks. The court indicated that the FDA’s directive was and is to determine whether a product is “appropriate for the protection of the public health.” This is the generally encompassing Public Health Standard.

The D.C. Circuit further addressed Prohibition Juice’s “surprise switcheroo” challenge. Prohibition Juice argued that the FDA deviated from its 2019 guidance to industry in requiring rigorous research data. The court noted that the TCA—not the guidance document—provides the basis for what evidence the FDA requires in making a marketing determination, and even with the guidance material, the FDA’s evidentiary requirements were spelled out plainly. It further noted that the FDA might, could, or may consider evidence in addition to rigorous research data. The court finally was not persuaded by the petitioner’s assertion that the FDA’s not reviewing its youth access plan favorably was a fatal flaw in the FDA’s processing, holding that even if the FDA made an error, 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 or appeal to the Supreme Court, the FDA’s decision to issue MDOs to the petitioners stands.