Synopsis

Wages and White Lion Investments and Vapetasia, manufacturers of flavored e-liquids containing nicotine for use in open-system e-cigarette devices, 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 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 companies challenged the FDA’s marketing denial orders, but the Fifth Circuit denied their petition for review and upheld the FDA decisions. The companies then petitioned the Fifth Circuit for a rehearing en banc, and on January 3, 2024, the en banc panel reversed. This means the FDA must do a full regulatory review of the petitioner’s applications.

Why it Matters for Public Health

Youth e-cigarette use, also known as vaping, significantly increased over the 2010s and into the 2020s. Over this time, thousands of flavored e-liquid products flooded the market. Flavors not only enhance the appeal of e-cigarettes but also make it more likely that non-users will begin vaping and less likely that users will quit. Of the many market authorization requests it has received from e-cigarette and e-liquid manufacturers, the FDA to date has not authorized any products that contain flavors other than tobacco. See the Public Health Law Center’s commentary for more information about these authorized products.

Background

The Family Prevention and Tobacco Control Act requires that “new tobacco products” (those commercially marketed after February 15, 2007) undergo a premarket review process and receive affirmative marketing orders before being sold in the U.S. In 2016, the FDA deemed e-cigarettes and their accessories, including flavored e-liquids, to fall within the scope of its regulatory authority under the Tobacco Control Act. Since then, the FDA has authorized 23 e-cigarettes, all of them tobacco-flavored, suggesting the possibility that the FDA might never authorize a flavored e-cigarette product.

Proceedings

Petitioners filed their PMTAs on September 9, 2021, seeking approval for products containing flavors that included sour grape, pink lemonade, milk and cookies, and concept flavors like “Suicide Bunny Bunny Season.” The FDA issued marketing denial orders to petitioners on September 14 and 16, 2021, citing among its reasons that the petitioners failed to provide evidence demonstrating that their flavored products provide a benefit to adult users that outweigh the risks to youth or that the flavored products provided benefits greater than those provided by tobacco-flavored products—that is, they had failed to demonstrate comparative efficacy. Petitioners filed their challenges to the FDA’s marketing denial orders in October, 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, in violation of the Administrative Procedure Act.

The Fifth Circuit rejected the petitioners’ arguments. On the 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 Tobacco Control Act that required applicants to show that their products present less risk than other tobacco products, a comparison that the FDA is required to consider as part of its review.

The court was also unpersuaded by the argument that the FDA acted arbitrarily and capriciously. Noting that where the FDA acts reasonably, a court is required to defer, the court found that, among other things, the FDA’s dismissal of a small study provided by one of the petitioners and its inclusion of facts and evidence that emerged after 2019 regarding youth consumption of flavored products did not rise to the level of arbitrary and capricious decision making.

Litigation Status (OPEN)

Wages and White Lion and Vapetasia petitioned the Fifth Circuit for an en banc rehearing, which was granted on January 19, 2023. On January 3, 2024, the en banc panel reversed.