FDA WARNING_LETTER - The Smoky Box LLC - December 13, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Pedro J. Moreau and Andre M. Sayegh, operating The Smoky Box, for offering unapproved Electronic Nicotine Delivery System (ENDS) products for sale on their website, https://thesmokybox.com. The FDA determined that products like "EB Design TE6000 – Juicy Peach" and "Funky Republic TI7000 – Peach Pie" are "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order.

These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required marketing authorization or notice. The letter emphasizes that all tobacco products, including those containing nicotine from any source (as per the Consolidated Appropriations Act, 2022), must comply with the FD&C Act. The company must cease the violative sale and distribution of these products and submit a written response within 15 working days detailing corrective actions, including discontinuation dates and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.