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KMT Distribution LLC, a distributor of e-liquid products containing nicotine, was found to be selling tobacco products without required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations requiring "new tobacco products" to obtain a marketing authorization order before being legally distributed in the United States. The violation applies to e-liquid products containing nicotine from any source, which fall under FDA jurisdiction as tobacco products under section 201(rr) of the Federal Food, Drug, and Cosmetic Act.