FDA WARNING_LETTER - Vape Texas LLC d/b/a Vape Texas Conroe - February 06, 2024

The FDA issued a Warning Letter to Vape Texas LLC d/b/a Vape Texas Conroe on February 1, 2024, following a review of inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, due to containing nicotine from any source and being intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the e-liquid product "Strappleberry" was cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information under section 905(j) was not provided.

The FDA states that the failure to provide a required report under section 905(j) is a prohibited act under section 301(p) of the FD&C Act. The company is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing the sale and distribution of non-compliant products and outlining a plan for future compliance. Failure to comply may result in regulatory