Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistSmoking Vibes LLC was warned for offering electronic nicotine delivery system (ENDS) products for sale through their website without required premarket authorization, in violation of the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's products—which contain nicotine from any source—qualify as tobacco products subject to FDA jurisdiction and must comply with premarket review requirements established under the Federal Food, Drug, and Cosmetic Act. The warning letter emphasized that as of March 2022, FDA jurisdiction expanded to include all nicotine-containing products regardless of whether the nicotine is derived from tobacco or other sources, and that "new tobacco products" cannot be legally marketed without premarket authorization orders in effect.