Loading…
Cool Vape LLC was cited for selling and distributing e-liquid tobacco products without required premarket authorization from the FDA. The company's products, which contain nicotine from any source, fall under FDA jurisdiction as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act and must comply with applicable regulations, including obtaining a marketing authorization order under section 910 of the FD&C Act before legal distribution in the United States. The FDA's inspection determined that the company's e-liquid products were being sold without the necessary premarket authorization required for all new tobacco products commercialized after February 15, 2007.