FDA WARNING_LETTER - Misty Mountain Vapors, LLC - October 08, 2019

The FDA Center for Tobacco Products issued a Warning Letter to Brenda Berry Long and Brian Dooley of Misty Mountain Vapors, LLC, following a review of their website, https://www.mistymountainvapors.com. The FDA determined that several e-liquid products advertised and sold on the website are misbranded tobacco products.

The core violation is the failure to include the required nicotine warning statement in the advertising for e-liquid products, such as "A Dope Life Berry Fun," "Angry Penguin," and "Cookie Monster." This violates 21 C.F.R. § 1143.3(b), which mandates the warning "WARNING: This product contains nicotine. Nicotine is an addictive chemical." for covered tobacco products. Consequently, the products are misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act, as the advertising is considered false or misleading due to the omission of material facts regarding the product's consequences.

The letter requires immediate corrective actions, including discontinuing violative labeling, advertising, sale, and distribution. A written response detailing these actions and a plan for maintaining compliance must be submitted within 15 working days. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.