FDA WARNING_LETTER - NES21 LLC, d/b/a Texas I-35 Vape - April 28, 2025

On April 17, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to NES21 LLC, d/b/a Texas I-35 Vape, following a review of inspection records. The FDA determined that the company manufactures, sells, and/or distributes e-liquid products, including "Dragon Fruit," which are considered 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 order, as mandated by section 910(a) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided.

The FDA requires NES21 LLC to submit a written response within 15 working days from receipt of the letter. The response must detail actions taken to address the violations, including dates of discontinued sale/distribution of the violative products and a plan for maintaining compliance. Failure to comply may result in regulatory