Vapes by Enushi – FDA Warning Letter, Dec 10, 2019
The FDA issued a Warning Letter to Brian Ywong regarding e-liquid products advertised and sold on vapesbyenushi.com to U.S. customers. The FDA determined these products are tobacco products under the FD&C Act.
The letter identifies two primary violations: 1. **Sales to Minors:** The "SLUSHY – Blue Raspberry SALTS e-liquid" was sold to a person under 18, violating 21 U.S.C. § 387c(a)(7)(B) and 21 C.F.R. § 1140.14(b), rendering the product misbranded. 2. **Missing Nicotine Warning Statement:** Advertising for an e-liquid product, exemplified by "MLV – Infusion Cool Melon Phix Pod," on the website failed to include the required nicotine warning statement ("WARNING: This product contains nicotine. Nicotine is an addictive chemical.") as mandated by 21 C.F.R. § 1143.3(b). This also misbrands the product under 21 U.S.C. § 387c(a)(7)(B) and 21 U.S.C. § 387c(a)(7)(A) for being misleading due to the omission of material facts.
The FDA requires immediate corrective actions for these and similar violations across
ID · 545fc302-23bf-4bf6-96a2-c78ca63621ea
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