FDA WARNING_LETTER - 5150 Premium Vape Fluid, Inc. - June 09, 2020

On May 22, 2020, the FDA issued a Warning Letter to Robin Colbran and Jy Colbran regarding their e-liquid products advertised and sold on https://5150eliquid.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is that the advertising for several e-liquid products, including Detox, Cinnsanity, 12 Monkeys, and Skull Candy, fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This omission violates 21 CFR 1143.3(b), which mandates this warning for covered tobacco products. Consequently, these products are misbranded under section 903(a)(7)(B) of the FD&C Act.

Furthermore, the absence of the required warning makes the advertising false or misleading, leading to misbranding under section 903(a)(7)(A) of the FD&C Act, as it fails to reveal material facts about the product's consequences.

The FDA requires immediate correction of these violations and any similar issues 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