FDA WARNING_LETTER - GPO Plus Inc, d/b/a Distro+ - June 26, 2025

On June 26, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to GPO Plus Inc, d/b/a Distro+, for selling and distributing unauthorized Electronic Nicotine Delivery System (ENDS) products. The FDA determined, based on inspection records, that Distro+ markets "new tobacco products" without the required premarket authorization.

Specifically, the product "VERSE BAR PEARL 7500 PUFFS PEACH GUMMY BEAR Nicotine Salt 5% 13mL" was identified as a new tobacco product not commercially marketed in the U.S. before February 15, 2007, and lacking an FDA marketing authorization order. This violates sections 910(c)(1)(A)(i) and 905(j) of the FD&C Act, rendering the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6).

The letter emphasizes that ENDS products, including those with nicotine from any source, are subject to FDA jurisdiction under the FD&C Act (21 U.S.C. § 321(rr), § 387a(b)) and 21 C.F.R. § 1100.1. Distro+ is required to ensure all tobacco products, labeling, and advertising comply