Stim Co. d/b/a Stimulus E-Liquids – FDA Warning Letter, Jun 16, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Cheol Kim after reviewing the website https://stimuluseliquids.com, which advertises and sells e-liquid products. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction. The primary violation identified is that the advertising for several e-liquid products, such as Stimulus Cereal Bowl and Fruit of Life, fails to include the mandatory nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This omission violates 21 CFR 1143.3(b) and consequently renders the e-liquid products misbranded under section 903(a)(7)(B) of the FD&C Act. The FDA requires immediate corrective actions, including discontinuing all violative advertising, labeling, sale, and distribution of these tobacco products. A written response detailing corrective actions and a plan for maintaining compliance must be submitted within 15 working days. Failure to comply may lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and detention of imported products.