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Upper Limits was warned for selling electronic nicotine delivery system (ENDS) products without required premarket authorization from the FDA, violating the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA requirements applicable to tobacco products containing nicotine from any source, which have been under FDA jurisdiction since the March 2022 legislation expanding the definition of regulated tobacco products. As a "new tobacco product" not commercially marketed in the United States before February 15, 2007, the products required a marketing authorization order under section 910 of the FD&C Act before being legally sold.