FDA WARNING_LETTER - Lotus Vaping Technology LLC - April 09, 2019

The FDA issued a Warning Letter to Ryan Muckenthaler regarding violations observed on the mobile website http://www.lotusvaping.com, where e-liquid products are manufactured and sold in the U.S. These e-liquids are classified as tobacco products under the FD&C Act.

The primary violations include: 1. **Sales to Minors:** The "Stranomenon" e-liquid product was sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). This renders the product misbranded under section 903(a)(7)(B) of the FD&C Act. 2. **Failure to Include Required Nicotine Warning Statement:** Several e-liquid products (e.g., Lqid Fins Out, Juice Guys Sasha, Lqid Bundle Pack) advertised on the website lacked the mandatory warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(a) and/or (b), leading to misbranding under section 903(a)(7)(B), and also sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act due to misleading labeling/advertising by omission of material