# FDA WARNING_LETTER - Texas Tobacco Barn LLC d/b/a TX VapeBarn - January 27, 2022

Source: https://www.keypedia.com/records/warning_letter/texas-tobacco-barn-llc-dba-tx-vapebarn/5c5c7fdb-0b34-41f2-9aaa-9469cad69056

> FDA WARNING_LETTER for Texas Tobacco Barn LLC d/b/a TX VapeBarn on January 27, 2022. Product: Tobacco. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Texas Tobacco Barn LLC d/b/a TX VapeBarn
- Inspection Date: 2022-01-27
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Texas Tobacco Barn LLC d/b/a TXVapeBarn for manufacturing and distributing e-liquid products, specifically "TXV BARN BREWED Beetle Juice 12mg 30ML," without required marketing authorization. These e-liquid products are deemed tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The violation stems from the product being a "new tobacco product" (not commercially marketed before February 15, 2007) that lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information under section 905(j) was not provided. The failure to provide such a report is also a prohibited act under section 301(p).

Although the firm is a registered manufacturer with over 2,400 listed products and submitted a Premarket Tobacco Product Application (PMTA) (STN PM0003537) on September 9, 2020, FDA issued a Marketing Denial Order for this application on September 8, 2021, covering 2,247 products.

## Related Officers

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

Company: https://www.keypedia.com/companies/texas-tobacco-barn-llc-dba-tx-vapebarn/ba754b54-7411-4153-a04d-eedf818bd428

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