Tobacco Paradise LLC – FDA Warning Letter, Oct 18, 2022

On September 30, 2022, the FDA issued a Warning Letter to Issa Elias Baba regarding the sale of Electronic Nicotine Delivery Systems (ENDS) products on the website https://tobaccoparadise.net. The FDA's Center for Tobacco Products determined that the "Green Smart Living Nicotine Refill 5 Pack" ENDS product was misbranded under section 903(a)(7)(B) of the FD&C Act because it was sold to an individual younger than 21 years of age.

The investigation revealed a direct violation of section 906(d)(5) of the FD&C Act, which prohibits the sale of tobacco products to persons under 21. This misbranding renders the product non-compliant with FDA regulations.

The letter emphasizes the responsibility to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to correct these violations may result in regulatory actions, including civil money penalties, seizure, injunction, or refusal of import. The FDA also noted the requirement for premarket authorization for "new tobacco products."

A written response detailing corrective actions, including discontinuation of violative sales and a plan for future compliance, is required within 15 working days. The reference number for the response is RW22