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North Disposable was cited for offering electronic nicotine delivery system (ENDS) products for sale on its website without obtaining required premarket authorization from the FDA, in violation of the Family Smoking Prevention and Tobacco Control Act. The company's products, which contain nicotine from any source, fall under FDA jurisdiction as tobacco products and must comply with premarket review requirements established under section 910 of the Federal Food, Drug, and Cosmetic Act. The FDA determined that these ENDS products were not commercially marketed in the United States as of February 15, 2007, making them "new tobacco products" subject to mandatory premarket authorization orders before legal distribution.