FDA WARNING_LETTER - Savelli Inc. - August 27, 2019

On August 22, 2019, the FDA issued a Warning Letter to Jacob Nesheiwat regarding e-liquid products sold on bonappetitvapours.com. The FDA determined these e-liquids are tobacco products under the FD&C Act.

The letter identifies two primary violations: 1. **Sales to Minors:** The website sold Villain Vapors Bonnie & Clyde e-liquid to a person younger than 18, violating 21 U.S.C. § 387c(a)(7)(B) and 21 C.F.R. § 1140.14(b). This misbrands the product under section 903(a)(7)(B) of the FD&C Act. 2. **Failure to Include Required Nicotine Warning Statement:** The website's advertising for Key Lime Pie, Smooth Tobacco, Strawberry Banana Smoothie, Strawberry Cheesecake, and Creme Brulee e-liquids lacked the mandatory warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(b) and misbrands the products under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act,