FDA WARNING_LETTER - Savelli Inc. - August 27, 2019

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Record Details

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,

Company: Savelli Inc.
Inspection Date: August 27, 2019
Product Type: Tobacco
Office: Center for Tobacco Products
People: Ann Simoneau (Director)
Ele Ibarra-Pratt (Acting Director)

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ID · 390fa41b-44cc-44eb-aea1-520d68ebf4b0

Violation Codes10

21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387c(a)(7)(B)21 U.S.C. 387c(a)(1)21 U.S.C. 387c(a)(7)(A)21 U.S.C. 321(n)21 CFR 1140.14(b)21 CFR 1140.321 CFR 1100.221 CFR 1143.3(b)

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