Texas Tobacco Barn LLC d/b/a TX VapeBarn – FDA Warning Letter, Jan 27, 2022

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.