Loading…
Jai Guruji LLC d/b/a Vape Marley was warned for offering electronic nicotine delivery system (ENDS) products for sale through its website without obtaining required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act. The FDA determined that the company's ENDS products, which contain nicotine from any source, are subject to FDA jurisdiction as tobacco products and must comply with applicable regulatory requirements, including obtaining a premarket authorization order before legally marketing new tobacco products in the United States. The warning was issued following FDA's review of the company's website, which listed ENDS products available for distribution to U.S. customers.