Vape Game LLC – FDA Warning Letter, Jun 16, 2020
On April 22, 2020, the FDA issued a Warning Letter to Dalton Baarstad, Terri Baarstad, and Taylor Jones, following a review of the website https://vape-game.com. The FDA determined that e-liquid tobacco products advertised and sold on this website are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
The core violation is the failure to include the required nicotine warning statement in the advertising for several e-liquid products, such as Shine Looker, Evaporeign Catacombs, Clean Lime Cupcake, Evaporeign Godspeed Flash, and Drip Line Grandma’s Cake Batter. According to 21 C.F.R. § 1143.3(b), advertising for covered tobacco products, including e-liquids, must bear the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." The website's advertising for these products did not comply with this requirement.
The FDA requires immediate correction of this violation and any similar issues to ensure compliance with the FD&C Act and its implementing regulations. Failure to comply may result in further actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions
ID · 89d5af80-3576-431a-a32e-300aaa792c0f
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