TVC Management Corp d/b/a The Vapor Chef – FDA Warning Letter, Apr 7, 2020

On March 27, 2020, the FDA issued a Warning Letter to Aras Azuolas regarding e-liquid products sold on thevaporchef.com. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is that advertising for several e-liquid products, including "Apple Cider Doughnut," "Frozen Lemon Curd - Nie Salt," and "Birch Beer," fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 CFR 1143.3(b).

Consequently, these e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act for violating regulations prescribed under section 906(d), and under section 903(a)(7)(A) because the advertising is considered misleading due to the omission of material facts regarding product consequences (section 201(n)).

The FDA requires immediate correction of these violations and any similar issues across all advertising platforms. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including dates of discontinued violative advertising/sales and a compliance plan, is required within 15 working days.