FDA WARNING_LETTER - EVO Brands, LLC and PVG2, LLC d/b/a Puff Bar - October 06, 2022

On October 6, 2022, the FDA Center for Tobacco Products issued a Warning Letter to Nicholas Minas Alfaro and Patrick Beltran, associated with EVO Brands, LLC and PVG2, LLC. The letter states that a review of puffbar.com and other information revealed that electronic nicotine delivery system (ENDS) products are being received and delivered in the United States without required marketing authorization.

These products, including "Puff Max - Clear," "Puff Max - Mystery," and "Puff Flow - Lemon Ice," are considered "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. The FDA determined that PVG2, LLC receives these products from a foreign manufacturer and distributes them, while EVO Brands, LLC and/or PVG2, LLC operate puffbar.com, which lists these products and directs consumers to retailers like Puffin Vape Shop and The Disposable World LLC.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing violative sales and distribution, and a plan for future compliance. Failure to