FDA WARNING_LETTER - Mitten Vapors - May 12, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Jamie Zichterman of Mitten Vapors, LLC, on April 22, 2020, following a review of their website, https://www.mittenvapors.com. The FDA determined that several e-liquid products, including Lemon Meringue Pie, Loop Dreams, and Pioneer, are tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is that the advertising for these e-liquid products on the website fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This omission renders the products misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), as it violates 21 CFR 1143.3(b) concerning advertising requirements for covered tobacco products.

The letter mandates immediate correction of this violation and similar issues 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. A written response detailing corrective actions, including dates of discontinuation of violative activities and a plan for sustained compliance, is required within 15 working days.