South Texas Vapor – FDA Warning Letter, Jun 11, 2020

The FDA issued a Warning Letter to South Texas Vapor for violations related to their e-liquid products, specifically "Cherry Jo e-liquid." The FDA determined that South Texas Vapor manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act.

The primary violations identified are: 1. **New Tobacco Product Without Required Marketing Authorization:** The "Cherry Jo e-liquid" is considered a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007. It lacks the required FDA marketing authorization order, making it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Failure to provide the required notice under section 905(j) is also a prohibited act (section 301(p)). 2. **Tobacco Product Without Required Ingredient Listing Submissions:** South Texas Vapor failed to provide an ingredient listing for its "Cherry Jo e-liquid" as required by section 904(a)(1) of the FD&C Act. This renders the product misbranded under section 903(a)(10)(A). Failure to provide this information is a prohibited act (section 301(q)(1)(B)). 3. **Tobacco Products Manufactured in an Establishment Not Duly Registered