# FDA WARNING_LETTER - DENTON VAPE SHOPPE - October 19, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/denton-vape-shoppe/94ea930c-af5c-49f8-b84b-f24da018ab8e

> FDA WARNING_LETTER for DENTON VAPE SHOPPE on October 19, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: DENTON VAPE SHOPPE
- Inspection Date: 2021-10-19
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Denton Vape Shoppe, identifying their e-liquid products as tobacco products subject to FDA jurisdiction. The letter states that the DENTON VAPE SHOPPE BLACK CHERRY 3MG e-liquid product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the manufacturing, sale, and/or distribution of this product without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no required notice or information was provided. Prohibited acts include holding for sale after interstate shipment resulting in adulteration/misbranding (section 301(k)) and failure to provide a required report (section 301(p)).

Denton Vape Shoppe, a registered manufacturer with over 1,000 listed products, is informed that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement, including civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing actions to address violations, including discontinuation dates of violative sales/distribution, and

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)

Company: https://www.globalkeysolutions.net/companies/denton-vape-shoppe/650f9378-5b44-43b6-9d54-c34b813e5222

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