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WARNING LETTER
•MVS Richardson, LLC d/b/a Metro Vapors Mesquite•April 21, 2020

FDA WARNING_LETTER - MVS Richardson, LLC d/b/a Metro Vapors Mesquite - April 21, 2020

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Record Details

The FDA issued a Warning Letter to MVS Richardson, LLC d/b/a Metro Vapors Mesquite for violations related to their e-liquid products, specifically "Cloud Concepts – Narcissist." The FDA determined these e-liquids are tobacco products subject to FDA jurisdiction.

The inspection revealed several violations: 1. **Misbranded Product (Packaging):** The "Cloud Concepts – Narcissist" e-liquid product packages lack the required nicotine warning statement ("WARNING: This product contains nicotine. Nicotine is an addictive chemical."), violating 21 C.F.R. § 1143.3(a) and rendering the product misbranded under sections 903(a)(7)(B) and 903(a)(1) of the FD&C Act. 2. **Misbranded Product (Ingredient Listing):** The company failed to provide an ingredient listing to the FDA for the "Cloud Concepts – Narcissist" e-liquid, as required by section 904(a)(1) of the FD&C Act. This misbrands the product under section 903(a)(10)(A) and is a prohibited act under section 301(q)(1)(B). 3. **Misbranded Product (Establishment Registration):** All e-liquid products manufactured by the company are misbranded under section 903(a)(6

Company
MVS Richardson, LLC d/b/a Metro Vapors Mesquite
Inspection Date
April 21, 2020
Product Type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
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ID · 0a55294a-8734-4d97-a28d-0a44ccf05b07

Violation Codes10
21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 CFR 1100.121 CFR 1143.3(a)21 U.S.C. 387c(a)(7)(B)21 U.S.C. 387c(a)(1)21 U.S.C. 321(n)21 U.S.C. 331(k)21 U.S.C. 387d(a)(1)21 U.S.C. 387c(a)(6)

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