Loading…
Vape Shop was found to be offering electronic nicotine delivery system (ENDS) products for sale without required premarket authorization from the FDA, in violation of the Family Smoking Prevention and Tobacco Control Act. The company was selling tobacco products—including those containing nicotine from non-tobacco sources, which fall under FDA jurisdiction following the March 2022 legislative expansion—that had not obtained the mandated marketing authorization order required for new tobacco products. Under section 910 of the Federal Food, Drug, and Cosmetic Act, all new tobacco products must receive FDA premarket approval before being legally marketed in the United States, a requirement that Vape Shop failed to meet.