Dongguan Hengtai Biotechnology, Co., Ltd d/b/a Mr. Fog Warning Letter Details

Summary

Dongguan Hengtai Biotechnology, operating as Mr. Fog, was warned for manufacturing and distributing electronic nicotine delivery systems (ENDS) products to U.S. customers without required premarket authorization. The company's products, listed on their website, contained nicotine and fell under FDA jurisdiction as tobacco products, but lacked the legally mandated premarket authorization orders necessary for new tobacco products under the Federal Food, Drug, and Cosmetic Act. This warning was issued in the context of expanded FDA jurisdiction that took effect in March 2022, extending regulatory authority to all products containing nicotine from any source, not just tobacco-derived nicotine.