FDA WARNING_LETTER - JBRANDS LLC - December 19, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Yehuda Gabay and Elad Barda on December 19, 2024, following a review of the website https://vapetyson.com. The letter addresses the unlawful marketing of electronic nicotine delivery system (ENDS) products, specifically "Tyson 2.0 Vape Round 2 - Coconut" and "Tyson 2.0 Vape Round 2 – Cherry Cola," in the United States. These products are considered "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed before February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i). Consequently, the FDA determined that these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the necessary notice or information under section 905(j) was not provided. The letter emphasizes that all tobacco products, including those containing nicotine from any source, must comply with the FD&C Act. The firm is required to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing sales and distribution, and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.