Synopsis

Bidi Vapor, Diamond Vapor, Johnny Copper, Vapor Unlimited, Union Street Brands, and Pop Vapor manufactured flavored nicotine-containing e-liquids for use in 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 2022. The 11th Circuit ruled in favor of the Petitioners on August 24, 2022, stating that FDA acted arbitrarily and capriciously in not considering the companies’ marketing and sales strategies, remanding the case to FDA to reevaluate.

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

Petitioners filed their respective PMTAs prior to the September 2020 deadline. One year later, FDA issued MDOs to the petitioners, with these MDOs stating that the “key basis for [the Administration’s] de-termination” was that “[a]ll of [the applications] lack[ed] sufficient evidence demonstrating that [the] flavored [products] will provide a benefit to adult users that would be adequate to outweigh the risks to youth.” 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 11th Circuit panel agreed with petitions, contra the conclusions reached by other Circuit Courts. The majority determined that FDA had led manufacturers to believe that marketing and sales plans were an important part of the PMTA review, noting that FDA’s own materials state that such materials are “directly relevant”, “critical”, and “necessary” to make a marketing determination, and so not reviewing them when provided constituted an unjustifiable action – particularly where FDA’s rationale for doing so is that the agency has “experience” and therefore did not need to analyze the plans that the manufacturers’ provided in their materials based on said experience assessing similar plans. The majority concluded that it was not on FDA to disregard but to consider what is submitted to it - deciding however it may afterwards. Contrasting with other Courts which reached a different judgment, the majority considered this to be not a “harmless error” on FDA’s part. The majority noted that their decision was procedural and FDA may reach the same conclusion after reviewing the marketing plans.

Litigation Status (OPEN/CLOSED)

The decision in the 11th Circuit stands unless FDA or Petitioners appeal. As noted in the dissent however, it is unlikely FDA would appeal – the agency can, and the dissent contends must, simply re-review the marketing and sales plans provided by the Petitioners and re-issue its MDOs. The Petitioners, for their part, may then re-file suit seeking review again. This particular case may be CLOSED pending any appeals, however the conflict and parties involved may end up substantively revisiting it as a new filing in the future.

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