Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistSK Investment Inc d/b/a SK Novelty Wholesale was cited for offering electronic nicotine delivery system (ENDS) products for sale on its website without required premarket authorization, in violation of the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA tobacco product regulations, which require "new tobacco products" containing nicotine from any source to obtain premarket authorization orders before legal U.S. marketing. The FDA's review of the company's website determined these ENDS products were being distributed to U.S. customers without the mandated compliance documentation.