Exotic Wholesale LLC – FDA Warning Letter, Sep 16, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Exotic Wholesale LLC, identifying that the company sells and distributes e-liquid products, specifically "Cloud Nurdz SALTS GUAVA PASSIONFRUIT 50mg 30ml," in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act, especially after the 2022 amendment extending jurisdiction to products with nicotine from any source. The FDA determined that the aforementioned e-liquid product is a "new tobacco product" because it was not commercially marketed before February 15, 2007, and lacks the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is 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 notice under section 905(j). Exotic Wholesale LLC is required to submit a written response within 15 working days, detailing actions taken to address these violations, including discontinuing the sale and distribution of the violative products and outlining a plan for future compliance. Failure to comply may lead to regulatory actions such as civil money penalties, product seizure, or injunction.