Loading…
Golden Leaf, LLC was found to be offering electronic nicotine delivery systems (ENDS) for sale through its website without the required premarket authorization from the FDA, in violation of the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA regulations governing tobacco products, including those containing nicotine from non-tobacco sources, which became subject to FDA jurisdiction following the March 2022 expansion of tobacco product definition. The FDA determined that ENDS products must obtain premarket authorization before being legally marketed in the United States, a requirement Golden Leaf had not met for its listed products.