NES21 LLC, d/b/a Texas I-35 Vape

Warning LetterOpen

NES21 LLC, d/b/a Texas I-35 Vape 640 South Stemmons Street, Suite 200 Sanger , TX 76266 United StatesIssued Apr 17, 2025Center for Tobacco Products

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateApr 17, 2025

Product TypeTobacco

StatusOpen

Letter Details

Firm: NES21 LLC, d/b/a Texas I-35 Vape
Location: NES21 LLC, d/b/a Texas I-35 Vape 640 South Stemmons Street, Suite 200 Sanger , TX 76266 United States
FEI Number: N/A
Country: United States
Issue Date: April 17, 2025
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

NES21 LLC, d/b/a Texas I-35 Vape manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization from the FDA. The company failed to comply with the Federal Food, Drug, and Cosmetic Act, which mandates that "new tobacco products" obtain premarket marketing authorization before being legally sold in the United States. The products in question fell under FDA jurisdiction as tobacco products because they contained nicotine from any source and were intended for human consumption, including products made with non-tobacco-derived nicotine as defined under the 2022 expanded regulatory authority.

NES21 LLC, d/b/a Texas I-35 Vape FDA Warning Letter, April 17, 2025