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WARNING LETTER
•Bouji Moj Oyeeb, Inc. d/b/a MasterMix E-Liquid•March 30, 2021

Bouji Moj Oyeeb, Inc. d/b/a MasterMix E-Liquid – FDA Warning Letter, Mar 30, 2021

Record Details

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.

Company
Bouji Moj Oyeeb, Inc. d/b/a MasterMix E-Liquid
Inspection date
March 30, 2021
Product type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
View Company Profile

ID · e747f64b-f01d-4c54-a759-4677599c7e25

Violation Codes10
21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 CFR 1100.121 U.S.C. 387j(a)21 U.S.C. 387j(c)(1)(A)(i)21 U.S.C. 387e(j)21 U.S.C. 387e(j)(1)(A)(ii)21 U.S.C. 387e(j)(3)FD&C Act 910(a)(2)(A)FD&C Act 902(6)(A)

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