Alohma, LLC, d/b/a Kure CBD & Vape Warning Letter Details

Summary

Alohma, LLC, operating as Kure CBD & Vape, was warned for selling and distributing e-liquid products containing nicotine without required FDA premarket authorization. The company's products fall under FDA jurisdiction as tobacco products under the Federal Food, Drug, and Cosmetic Act, as they contain nicotine from any source and are intended for human consumption. The products appeared to be marketed without the legally required premarket authorization orders that apply to "new tobacco products" under FDA regulations.