# FDA WARNING_LETTER - Mountain Vaporz LLC - September 03, 2019

Source: https://www.keypedia.com/records/warning_letter/mountain-vaporz-llc/c73cc95e-186a-4cc0-809a-7744e82a6ee5

> FDA WARNING_LETTER for Mountain Vaporz LLC on September 03, 2019. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Mountain Vaporz LLC
- Inspection Date: 2019-09-03
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: 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

## Related Documents

- [WARNING_LETTER - 2023-07-20](https://www.keypedia.com/records/warning_letter/mountain-vaporz-llc/3b61d3e1-b4c9-44d4-83ff-bbfe939ea49c)

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Kim M. Predmore](https://www.keypedia.com/people/kim-m-predmore/ea855cad-89e4-4beb-81be-9562322995ae)

Company: https://www.keypedia.com/companies/mountain-vaporz-llc/0669d6a3-923d-4440-b479-137bdd103544

Office: https://www.keypedia.com/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374