FDA WARNING_LETTER - RSB Traders Ltd t/a Vapor Shop Direct - September 24, 2019
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On August 20, 2019, the FDA issued a Warning Letter to Vapor Shop Direct, based in the United Kingdom, after reviewing their website, vaporshopdirect.com. The FDA determined that e-liquid products offered for sale to U.S. customers are tobacco products under the FD&C Act.
The letter identifies two primary violations: 1. **Sales to Minors:** Vapor Shop Direct sold "Cool Ice Mint Nic Salt e-liquid" to a person younger than 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. **Failure to Include Required Nicotine Warning Statement:** The website's labeling and/or advertising for several e-liquid products (e.g., Lolly Vape Co ‘Who Loves Orange Soda?’, Milk & Cookies Black Series by Kilo Black Series, Silver Blend Nic Salts by Nasty Salt, Sweet Tobacco Nic Salt by I Love Salts) failed to include the mandatory warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R § 1143.3(b) and results in misbranding under sections 903(a)(7)(B), 903(a
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