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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.