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Talk to a SpecialistTalk to a SpecialistKidney Puncher LLC was cited for manufacturing and selling e-liquid tobacco products without the required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquids, which fall under FDA jurisdiction as newly deemed tobacco products (effective August 8, 2016), were found to be adulterated and misbranded because they lacked the legally mandated premarket approval order needed for new tobacco products to be legally marketed in the United States. The FDA determined these violations through a review of the company's website, which displayed e-liquid products available for sale and distribution to U.S. customers.