Vape Tampa Bay and Downtown Vaporium LLC – FDA Warning Letter, Jun 13, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Andrew Nawoichik of Downtown Vaporium after reviewing their website, https://downtown-vaporium.myshopify.com. The FDA determined that e-liquid products offered for sale are tobacco products under section 201(rr) of the FD&C Act, especially following the March 2022 amendment extending jurisdiction to products containing nicotine from any source. The primary violation identified was the sale of Orchard Blends by Five Pawns – Nana Berry e-liquid to an individual under 21 years of age. This action constitutes a violation of section 906(d)(5) of the FD&C Act, rendering the product misbranded under section 903(a)(7)(B) of the FD&C Act. The letter emphasizes the retailer's responsibility to ensure compliance with all applicable provisions of the FD&C Act and FDA's implementing regulations, including age restrictions. Failure to address these violations may lead to regulatory actions such as civil money penalties, seizure, and/or injunction. The firm is required to submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for maintaining compliance. The FDA also reminded the firm about premarket authorization requirements for "new tobacco products."