FDA WARNING_LETTER - Tasty Puff LLC - June 09, 2020

The FDA issued a Warning Letter to Erin Kay regarding e-liquid products sold on tastypuff.com. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act. The primary violation is that advertising for several e-liquid products, including "Tasty Puff Silly Strawberry E-juice," "Tasty Puff Ghetto Grape E-juice," and "Tasty Puff Convicted Melon E-juice," 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, these 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) for having misleading advertising due to the failure to reveal material facts (nicotine content and addictiveness). The letter requires immediate correction of this violation and similar ones 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 discontinuation dates and compliance plans, is required within 15 working days.