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Talk to a SpecialistTalk to a SpecialistBreathe Easy Vapes, LP manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, in violation of the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products were deemed tobacco products subject to FDA jurisdiction as electronic nicotine delivery systems, yet the firm failed to secure the mandatory "new tobacco product" premarket approval required under section 910(a) of the Federal Food, Drug, and Cosmetic Act. The FDA's inspection records and review of the company's submissions identified these unapproved products being offered for commercial sale and distribution in the United States.