FDA WARNING_LETTER - MVS Richardson, LLC d/b/a Metro Vapors Mesquite - April 21, 2020
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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
- Inspection Date
- April 21, 2020
- Product Type
- Tobacco
ID · 0a55294a-8734-4d97-a28d-0a44ccf05b07
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