JBRANDS LLC – FDA Warning Letter, Dec 19, 2024
On December 19, 2024, the FDA issued a Warning Letter to Yehuda Gabay and Elad Barda, regarding the sale and distribution of electronic nicotine delivery system (ENDS) products on the website https://vapetyson.com. The FDA determined that products listed on the website, specifically "Tyson 2.0 Vape Round 2 - Coconut" and "Tyson 2.0 Vape Round 2 – Cherry Cola," are tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, due to containing nicotine from any source.
These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.
The letter mandates prompt action to address these violations and bring the products into compliance. A written response is required within 15 working days, detailing actions taken, including discontinuation of sales and distribution, and a plan for maintaining compliance. Failure to
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