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Talk to a SpecialistTalk to a SpecialistK & C Aitken, LLC dba Elysian Labs Distribution, Inc. manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required FDA premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, which fall under FDA jurisdiction as tobacco products containing nicotine from any source under amended regulations effective April 14, 2022, were being offered for sale through their website without compliance with Federal Food, Drug, and Cosmetic Act requirements. The FDA determined these products were adulterated and misbranded because they lacked the legally required premarket authorization orders necessary to be marketed in the United States.