FDA WARNING_LETTER - City of Vape - August 20, 2019

The FDA Center for Tobacco Products issued a Warning Letter to Gokul Joe and Sam Corp. (City of Vape) following a review of their mobile website, http://www.cityofvape.com. The FDA determined that the company's e-liquid products, specifically Reds Apple Nicotine Salts e-liquid, are tobacco products subject to FDA jurisdiction under section 201(rr) of the FD&C Act. The primary violation identified was the sale of Reds Apple Nicotine Salts e-liquid to a person younger than 18 years of age. This action constitutes a violation of 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products to minors. Consequently, the product is deemed misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). The letter emphasizes the company's responsibility to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. The FDA requires immediate correction of this violation and similar issues. The company must submit a written response within 15 working days detailing corrective actions, including dates of discontinuing violative sales and a plan for future compliance. Failure to comply could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction.