FDA WARNING_LETTER - Pitbull Vape Juice, LLC - September 29, 2020

On September 11, 2020, the FDA's Center for Tobacco Products issued a Warning Letter to Sharon K. Imhoff regarding e-liquid products sold on http://pitbullvapejuice.com. The FDA determined these e-liquids are "tobacco products" under section 201(rr) of the FD&C Act.

The primary violation identified is that advertising for several e-liquid products, including "Pitbull Vape Juice Brindle," "Pitbull Vape Juice Puppy Drool," and "Pitbull Vape Juice Pibble Loops," 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).

Consequently, these e-liquid products are deemed misbranded under section 903(a)(7)(B) of the FD&C Act because they violate regulations prescribed under section 906(d). Additionally, they are misbranded under section 903(a)(7)(A) of the FD&C Act, as the advertising is considered misleading due to the failure to reveal material facts concerning product consequences, per section 201(n).

The letter mandates immediate correction of these violations and similar issues across all advertising platforms. A written response detailing corrective actions, including dates of discontinued violative activities and a compliance plan, is required within