Wadina Distribution Company LLC d/b/a Gost Vapor – FDA Warning Letter, Aug 23, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to Amjad Daoud concerning e-liquid products sold on gostvapor.com. The FDA determined that products, including "The Pancake House- Golden Maple," "The Milk House- Parfait," and "The Pancake House- Raspberry," are tobacco products under section 201(rr) of the FD&C Act, encompassing those with nicotine from any source due to recent legislative amendments. These e-liquids are classified as "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The primary violation is the manufacturing and offering for sale of these new tobacco products without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j). The FDA has not received an application for marketing authorization for these products. A written response is required within 15 working days, detailing corrective actions, discontinuation of violative activities, and a plan for sustained compliance. Non-compliance may lead to regulatory actions like civil money penalties, seizure, injunction, or import detention.