FDA WARNING_LETTER - OK Smokey Ltd.

The FDA's Center for Tobacco Products reviewed the website http://www.ok-smokey.com and determined that its e-liquid products, specifically Crunch Berry V-Juice, are tobacco products subject to FDA jurisdiction under sections 201(rr) and 901(b) of the FD&C Act. The primary violation identified was the sale of Crunch Berry V-Juice e-liquid to a person younger than 18 years of age. This action constitutes a misbranding violation under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), as it contravenes 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products to minors. The letter emphasizes that retailers must not sell e-liquids or other covered tobacco products to individuals under 18. OK Smokey Ltd. is required to immediately correct this violation and ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. A written response detailing corrective actions, including dates of discontinuation of violative sales and a compliance plan, must be submitted within 15 working days. Failure to comply may lead to further enforcement actions such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction.