Ralfy's Emporium – FDA Warning Letter, Dec 10, 2019
The FDA issued a Warning Letter to Adam Horsepool and Elizabeth Hamer of ralfysemporium.com after reviewing their website, which advertises and sells e-liquid products to U.S. customers. These e-liquids are classified as tobacco products under the FD&C Act.
The FDA identified two primary violations: 1. **Sales to Minors:** The website sold "Ultimate Salts Candy Drops Watermelon and Cherry e-liquid" to a person under 18 years of age, violating 21 C.F.R. § 1140.14(b). This renders the product misbranded under section 903(a)(7)(B) of the FD&C Act. 2. **Missing Nicotine Warning Statement:** Advertising for an e-liquid product, specifically "ZAP! Juice Nic Salt," on the website failed to include the required nicotine warning statement ("WARNING: This product contains nicotine. Nicotine is an addictive chemical.") as mandated by 21 C.F.R. § 1143.3(b). This omission also misbrands the product under sections 903(a)(7)(B) and 903(a)(7)(A) of the FD&C Act, as it constitutes misleading advertising by failing to reveal material facts.
The letter requires immediate corrective actions for these and similar violations to ensure compliance with the FD
ID · 649e0866-3d79-4f95-a994-9ce4f88f0037
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