FDA WARNING_LETTER - 9 South Vapes, LLC - July 23, 2019

The FDA Center for Tobacco Products reviewed the website https://www.9southvapes.com and determined that the e-liquid products, specifically Cereal Killa e-liquid, 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 Cereal Killa e-liquid to a person younger than 18 years of age, which was revealed during an FDA investigation. This action constitutes a violation of 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products to minors. Consequently, the Cereal Killa e-liquid product is deemed misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). The Warning Letter requires 9 South Vapes to immediately correct this violation and any similar deficiencies. The firm must ensure all its tobacco products, labeling, and advertising across all platforms comply with the FD&C Act and FDA regulations. A written response detailing corrective actions, including dates of discontinuation of violative sales and a plan for sustained compliance, is required within 15 working days. Failure to comply may lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.