FDA WARNING_LETTER - Ruthless Vapor Corporation - November 16, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Ramon Barredo after reviewing websites ruthlessvapor.com and ruthlesswholesale.com, identifying electronic nicotine delivery system (ENDS) products offered for sale in the United States. The FDA determined that products such as Loaded TFN Disposable – Banana Ice, Mango Banana Ice, and Strawberry Banana Ice are "new tobacco products" under section 201(rr) of the FD&C Act, including those containing non-tobacco nicotine. These products are being marketed without the required premarket authorization order under section 910(a) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the failure to provide required notice or information under section 905(j). The FDA also expressed concern that the product labeling and advertising imitate children’s toys and the packaging conceals the product's nature, potentially promoting youth use. The firm is required to submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and advertising, and outlining a plan for maintaining compliance. Failure to address these violations may lead to regulatory actions such as civil money penalties, seizure, or injunction.