FDA Files Permanent Injunctions Against Six Small Vape Shops for Alleged Premarket Review Violations


On October 18, 2022, the U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administration (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.

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.”

Read full article here.

Azim Chowdhury and Ian J. Murray – The Continuum of Risk – 2022-10-25.

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