FDA WARNING_LETTER - Juice Spot - June 16, 2020

On April 22, 2020, the FDA issued a Warning Letter to Barry Greenberg regarding e-liquid products sold on vaporjuicespot.com. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act.

The primary violation is that several e-liquid products, including Apple Puff, Arctic Dragon, and Sour Gummy Bites, are misbranded under sections 903(a)(7)(B) and 903(a)(7)(A) of the FD&C Act. This is because their website advertising fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 CFR 1143.3(b). The absence of this warning also renders the advertising misleading, contributing to the misbranding.

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