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Vapeify was selling electronic nicotine delivery system (ENDS) products through its website without obtaining required premarket authorization from the FDA, in violation of the Federal Food, Drug, and Cosmetic Act. The company's products fell under FDA tobacco product jurisdiction because they contained nicotine from any source, which became subject to FDA regulation under amendments to the FD&C Act effective March 15, 2022. As "new tobacco products" not commercially marketed in the U.S. prior to February 15, 2007, the ENDS products required a marketing authorization order under section 910 of the FD&C Act before being legally marketed.