FDA WARNING_LETTER - Vape4Less - May 01, 2024

On April 30, 2024, the FDA issued a Warning Letter to Bishoy Gerges of Vape4less.com, following a review of their website which revealed the sale and distribution of electronic nicotine delivery system (ENDS) products to U.S. customers. These products are classified as tobacco products under section 201(rr) of the FD&C Act, including those containing nicotine from any source, as amended by the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Specifically, the products Lost Mary OS5000 – Cherry Banana Duo Ice, Funky Republic Ti7000 – Cantaloupe Apple, and Elf Bar – EB Design BC5000 – Watermelon Ice 13mL were cited. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. Consequently, they are 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 notices or information.

Vape4less.com is required to submit a written response within 15 working days detailing actions taken to address