Mountain Vaporz LLC – FDA Warning Letter, Sep 3, 2019
The FDA issued a Warning Letter to Mountain Vaporz, LLC on August 22, 2019, following a review of their website, https://mountainvaporz.com. The FDA determined that the company's e-liquid products are tobacco products subject to FDA jurisdiction.
The letter identifies two primary violations: 1. **Sales to Minors:** Mountain Vaporz, LLC sold "Caramel Frappe e-liquid" to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). This makes 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 advertising for several e-liquid products (e.g., Alien Blood, Apple, Caramel Frappe) failed to include the required nicotine warning statement. * The labeling for the "Caramel Frappe e-liquid" product did not display the required nicotine warning statement in the manner required by 21 C.F.R. § 1143.3. Instead, it used a modified statement: "WARNING! This product may contain Nicotine. Nicotine is an addictive chemical."
These failures constitute misbranding under section 903(a)(7)(B) of the FD
ID · c73cc95e-186a-4cc0-809a-7744e82a6ee5
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