Vapejoose Inc – FDA Warning Letter, Jul 16, 2019

The FDA issued a Warning Letter to Vapejoose, Inc. after reviewing its website, shopjoose.com, and determining that its e-liquid products are regulated tobacco products under the FD&C Act. The inspection revealed two primary violations. First, the company sold Vapejoose Blueberry Cheesecake e-liquid to a person younger than 18 years of age, which is a violation of 21 C.F.R. § 1140.14(b) and renders the product misbranded under section 903(a)(7)(B) of the FD&C Act. Second, several e-liquid products' labeling and/or advertising on the website failed to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This omission violates 21 C.F.R. § 1143.3(a) and/or (b), leading to misbranding under FD&C Act sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A). The FDA requires Vapejoose, Inc. to immediately correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act and its implementing regulations. A written response detailing corrective actions, including dates of discontinuation of violative practices and a compliance plan, must be submitted within 15 working days. Failure to comply may result in severe enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction.