FDA WARNING_LETTER - Dragonfly eCigs - March 24, 2020

The FDA issued a Warning Letter to Norman Gene Tucker regarding e-liquid products sold on draqonflyecigs.com. The FDA determined these e-liquids are tobacco products under the FD&C Act. The primary violation is that advertising for several e-liquid products, including "Wild Cherry" and "Darkside Skittles," fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(b).

Consequently, the 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 about the product's consequences.

The letter requires immediate correction of these and similar violations 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 discontinuation of violative activities and a plan for compliance, is required within 15 working days.