On October 18, 2022, the U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administrat
ion (FDA), filed complaints for permanent injunctions against six domestic e-liquid manufacturers across different federal district courts, all of which appear to be small vape shops that were producing nicotine-containing e-liquids used in open-system e-cigarette devices. The injunctions would require the manufacturers and named individuals to stop manufacturing, selling, and distributing any unauthorized new tobacco products, including their own nicotine e-liquids and components and parts thereof, as well as unauthorized third-party produced vaping products that might still be wading through the onerous Premarket Tobacco Product Application process.[1]
As noted in FDA’s press release, “these cases represent the first time FDA has initiated injunction proceedings to enforce the [Federal Food, Drug, and Cosmetic Act (FFDCA)] premarket review requirements for new tobacco products.”[2]
FDA stated that they previously warned each of the defendant-manufacturers that they were in violation of the premarket review requirements set forth in the FFDCA, as amended by the Family Smoking Prevention and Tobacco Control Act. However, according to FDA, the defendant-manufacturers allegedly “continued to illegally manufacture, sell, and distribute their products.”[3]
These actions, in connection with earlier activities such as the warning letters sent to EVO Brands LLC and PVG2 LLC (d/b/a Puff Bar),[4] consist of a larger “comprehensive approach to enforcing the law,” according to FDA.[5]
This joint DOJ/FDA action against these six comparatively small vape shops, and FDA’s strong words on preventing manufacturers from allegedly skirting FFDCA’s compliance, draws a strong contrast to the lack of Agency enforcement action against importers and distributors of mass-marketed and often youth-appealing Chinese-manufactured disposable e-cigarettes and counterfeit products, none of which have FDA marketing authorization. These importers and distributors consist of a significantly larger fraction of the e-cigarette market than the de minimis market share the six named defendant-manufacturers represent.
The defendant-manufacturers now can either agree to consent decrees of a permanent injunction, thereby preventing the small businesses from directly or indirectly manufacturing, selling, or distributing any new tobacco products that do not have marketing authorization or, should the defendant-manufacturers reject the consent decrees, the government can request the relevant courts to enter injunctions preventing those defendants from directly or indirectly manufacturing, selling, or distributing any unauthorized tobacco products.
Be sure to register for Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium on February 15 – 16, 2023, in Irvine, California. Details and registration information can be found here.
[1] See FDA, DOJ Seek Permanent Injunctions Against Six E-cigarette Manufacturers, available at: https://www.fda.gov/news-events/press-announcements/fda-doj-seek-permanent-injunctions-against-six-e-cigarette-manufacturers?utm_medium=email&utm_source=govdelivery.
[2] Id.
[3] Id.
[4] See 2022 National Youth Tobacco Survey Indicates Modest Increase in Youth Vaping Rates, available at: https://www.thecontinuumofrisk.com/2022/10/2022-national-youth-tobacco-survey-indicates-modest-increase-in-youth-vaping-rates/.
[5] See FDA, DOJ Seek Permanent Injunctions Against Six E-cigarette Manufacturers, available at: https://www.fda.gov/news-events/press-announcements/fda-doj-seek-permanent-injunctions-against-six-e-cigarette-manufacturers?utm_medium=email&utm_source=govdelivery.