FDA WARNING_LETTER - Bouji Moj Oyeeb, Inc. d/b/a MasterMix E-Liquid - March 30, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Richard Banaski after reviewing the website https://mastermixeliquid.com, determining that e-liquid products, specifically MasterMix E-Liquid - Mango and MasterMix E-Liquid - Maraschino Cherry, are manufactured and offered for sale in the U.S. These products are classified as "new tobacco products" under section 910(a) of the FD&C Act, as they were not commercially marketed before February 15, 2007, and are subject to FDA regulation per section 901(b) and 21 C.F.R. § 1100.1. The primary violations are that these e-liquid products lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the 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 firm is responsible for ensuring all tobacco products and marketing comply with the FD&C Act and regulations. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, or injunction. A written response detailing corrective actions, including discontinuing violative activities and a compliance plan, is required within 15 working days.