The TVECA’s lawyers handled the landmark litigation that established the legal framework for the industry as it exists today. They represented an e-cigarette distributor in its case against the U.S. Food and Drug Administration (FDA) when inbound shipments of its products from overseas manufacturers were detained by Customs officials at U.S. ports of entry at the direction of the FDA, which claimed that e-cigarettes were an unapproved new drug-device combination under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The attorneys successfully argued that e-cigarettes are the functional equivalent of traditional cigarettes and should be regulated as such.
Among other things, our lawyers successfully argued that because Congress had enacted the 2009 Family Smoking Prevention and Tobacco Control Act ("Tobacco Act") (which for the first time permitted FDA to regulate tobacco products), when not marketed as smoking cessation devices, e-cigarettes did not fall under FDA’s regulatory jurisdiction as drug-device combinations. If Congress already had authority to regulate e-cigarettes as drugs, medical devices, or drug-device combination products under its existing statutory authorities, why would it need the new authority conferred by the Tobacco Act? The court agreed with their argument that, as respects e-cigarettes, the Tobacco Act and its statutory definition of “tobacco product”—which includes e-cigarettes and other vaping products containing naturally derived nicotine—would be completely superfluous if such products were already drugs, devices, or drug-device combination products. Indeed, the only alternative would be that such products would be regulated as drugs, medical devices, or combination products and face an even more burdensome regulatory regime. The decision resulted in a clearer definition of the FDA’s scope of authority to regulate the use of e-cigarettes in the United States under the FD&C Act and the 2009 Tobacco Control Act.
-The TVECA Legal Team
