FDA WARNING_LETTER - Vape Deal, LLC - July 20, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Meklek Suna Sarsilmaz Gol regarding the sale of unauthorized electronic nicotine delivery system (ENDS) products on the website https://www.vapedeal.com. The FDA determined that products like "Naked 100 E-Liquid Pods - Amazing Mango" and "Strawberry Churrios by The Milkman" are "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007, and lack required FDA marketing authorization.

These products are cited as adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of premarket authorization or substantial equivalence reports. The FDA expressed particular concern about the "Strawberry Churrios by The Milkman" product, as its packaging imitates food products appealing to children, raising concerns about youth appeal and use of ENDS.

The letter mandates prompt corrective actions, including discontinuing the violative sale and distribution of these products. A written response detailing corrective actions and a plan for compliance must be submitted within 15 working days. Failure to comply may result in civil money penalties, seizure, and/or injunction.