FDA WARNING_LETTER - Performance Plus Marketing Inc.

On June 18, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Performance Plus Marketing Inc. following a review of inspection records. The company was found to be selling and distributing Electronic Nicotine Delivery System (ENDS) products in the United States.

The FDA determined that three specific ENDS products—FLUM MELLO 20000 BLUE RAZZ ICY 5% 15ML, FLUM MELLO 20000 COOL MINT 5% 15ML, and FLUM MELLO 20000 SOUR APPLE ICY 5% 15ML—are "new tobacco products" as defined by section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)). These products were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization orders under section 910(c)(1)(A)(i) of the FD&C Act.

Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C