Puckerfish, LLC – FDA Warning Letter, Sep 29, 2020

On September 11, 2020, the FDA issued a Warning Letter to Matt Dawson regarding e-liquid products sold on http://www.puckerfishvape.com. The FDA determined these e-liquid products are tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is that several e-liquid products, including Puckerfish Coffee, Puckerfish Choco, and Puckerfish Flewps, are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This is because their website advertising fails to include the required nicotine warning statement, violating 21 CFR 1143.3(b). This regulation mandates that advertising for covered tobacco products, such as e-liquids, must bear the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical."

The letter emphasizes the company's responsibility to ensure all tobacco products, labeling, and advertising across all platforms comply with the FD&C Act and FDA regulations. Failure to correct these violations may lead to regulatory action, including detention and refusal of admission for imported products. The company is required to submit a written response within 15 working days detailing corrective actions, including dates of discontinuation of violative advertising/sales, and a plan for maintaining