Nu Distributions, LLC d/b/a Vapeszn – FDA Warning Letter, Feb 27, 2024

The FDA issued a Warning Letter to David Leib of Vapeszn.com on February 16, 2024, following a review of their website, which offers electronic nicotine delivery system (ENDS) products for sale in the United States. The FDA determined these products are "tobacco products" under the FD&C Act, including those containing nicotine from any source, as per the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, the products EB Design TE6000 Disposable – Watermelon Ice 4%, EB Design TE6000 Disposable – Strawberry Ice 4%, and Funky Republic Vape Ti7000 Puffs – Cantaloupe Apple 50mg were cited. These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing authorization order or exemption.

Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for failing to provide required information under section 905(j). The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance. Failure to comply may