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HS Wholesale Limited was cited for selling and distributing e-liquid products containing nicotine without required premarket authorization from FDA. Under the expanded definition of tobacco products that includes all products containing nicotine from any source (effective March 2022), e-liquid products must obtain a marketing authorization order before being legally sold in the United States. The company had failed to comply with FDA's tobacco product regulations under the Family Smoking Prevention and Tobacco Control Act and was required to demonstrate compliance or cease distribution of these products.