E-Cig Vault – FDA Warning Letter, Jun 30, 2020

The FDA issued a Warning Letter to Jason Lopez on June 25, 2020, following a review of the website https://www.ecigvault.com. The FDA determined that e-liquid products advertised and sold on the website are tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is that several e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This is because the website advertising for products like Caramel Apple Pop by CA Pop, Icy Peach by Midas, and The Razz by Dr. Shugar Chitz fails to include the required nicotine warning statement as mandated by 21 CFR 1143.3(b). The regulation requires the statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." and specifies its placement and appearance.

The FDA requires immediate corrective action for the identified violation and any similar instances across all advertising platforms. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including dates of discontinuation of violative advertising/sales, and a plan for ongoing compliance