Vanilla Vapes Limited – FDA Warning Letter, Oct 15, 2019
The FDA Center for Tobacco Products reviewed the website https://www.vanillavapes.co.uk and determined that e-liquid products advertised and sold to U.S. customers are tobacco products under section 201(rr) of the FD&C Act.
Violations include: 1. **Sales to Minors:** The "50/50 Unflavoured e-liquid" was sold to a person younger than 18, violating 21 C.F.R. § 1140.14(b). This product is misbranded under section 903(a)(7)(B) of the FD&C Act. 2. **Missing Nicotine Warning Statement:** Several e-liquid products (e.g., Chef’s Vapours Blue Slush, Oasis Black Grape, Vampire Vape Black Jack) advertised on the website lack the required warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(b) and renders the products misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act due to false or misleading advertising/labeling.
The FDA requires immediate correction of these violations and similar issues.
ID · 4e0ff92f-d4fb-4f98-b697-a4e8d297781b
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