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lowkeydis.com was found to be offering electronic nicotine delivery system (ENDS) products for sale in the United States without the required premarket authorization from FDA, in violation of the Federal Food, Drug, and Cosmetic Act. The company's website contained tobacco products containing nicotine that had not been commercialized prior to February 15, 2007, and therefore qualified as "new tobacco products" requiring a marketing authorization order before legal sale. The FDA determined these products fell under its jurisdiction as tobacco products under the expanded definition that includes any product containing nicotine from any source, effective April 14, 2022.