FDA WARNING_LETTER - Good Guy Vapes Lab LLC - August 30, 2022

The FDA issued a Warning Letter to Shoaib Iqbal, operating Good Guy Vapes, on August 24, 2022, following a review of their website, goodguyvapes.com. The FDA determined that e-liquid products, specifically Melon Madness, Wubblicious, and Big League, are manufactured and offered for sale or distribution in the U.S. without the required marketing authorization. These e-liquids are deemed tobacco products under sections 201(rr) and 901(b) of the FD&C Act and 21 C.F.R. § 1100.1. As "new tobacco products" not commercially marketed before February 15, 2007, they require a premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. The absence of this authorization renders the products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required information under section 905(j). The letter stresses the firm's responsibility to ensure compliance with the FD&C Act and warns of potential enforcement actions, including civil money penalties, seizure, or injunction, for unaddressed violations. Good Guy Vapes must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative activities and a plan for future compliance.