FDA WARNING_LETTER - Southern Cloud Cartel LLC

The FDA Center for Tobacco Products issued a Warning Letter to Travis Karasek and Nakomah Hanson, operating southerncloudcartel.com, for violations related to the sale of electronic nicotine delivery system (ENDS) products. The FDA reviewed the website and determined that JUULpod Cool Mint Cartridges, classified as tobacco products under section 201(rr) of the FD&C Act, were offered for sale in the U.S.

The primary violation identified was the sale of JUULpod Cool Mint Cartridges to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including ENDS, to individuals under 18. The product is deemed a "covered tobacco product" under 21 C.F.R. § 1140.3 and § 1100.2.

The letter requires immediate correction of this violation and similar issues, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure,