FDA WARNING_LETTER - Elite Vaporworks

The FDA Center for Tobacco Products and the U.S. Federal Trade Commission issued a Warning Letter to Jayson Vaughn concerning Whip?d Strawberry e-liquid products sold on elitevaporworks.com, which are classified as tobacco products under the FD&C Act. FDA identified two significant violations. Firstly, the product is misbranded under FD&C Act sections 903(a)(1) and/or 903(a)(7)(A) because its labeling and advertising are false or misleading. The product's packaging, scent, and name imitate food products, specifically Reddi Wip whipped cream, making it appealing to children and posing a risk of accidental nicotine ingestion and acute toxicity. Secondly, the product is misbranded under FD&C Act section 903(a)(7)(B) and violates 21 C.F.R. § 1140.14(b) due to the sale of Whip?d Strawberry e-liquid to a minor. The FTC also reviewed the marketing under Section 5 of the FTC Act, concluding that the child-appealing presentation and scent could present an unwarranted health and safety risk. The company must submit a written response to FDA within 15 working days detailing corrective actions and a compliance plan, and separately notify the FTC within 15 days of actions taken. Non-compliance may lead to severe FDA enforcement actions, including civil money penalties and criminal prosecution.