FDA WARNING_LETTER - Wise Guys Vapes - May 16, 2025

The FDA issued a Warning Letter to Wise Guys Vapes on May 15, 2025, following a review of inspection records, determining the company sells and distributes e-liquid products in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction and compliance requirements. The letter highlights that the definition of "tobacco product" was expanded on March 15, 2022, to include products containing nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. A "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified product marketed after this date, requiring a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, or an exemption.

Specifically, the product "7 DAZE FUSION RASPBERRY GREEN APPLE WATERMELON 100mL 3mg/mL" is cited as a new tobacco product lacking an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided under section 9