FDA WARNING_LETTER - Joyetech Shenzhen Electronics Co., Ltd. - May 09, 2023

The FDA Center for Tobacco Products reviewed Joyetech's websites, joyetech.com and store.joyetech.com, and determined that the company is manufacturing and selling Electronic Nicotine Delivery System (ENDS) products in the U.S. without required marketing authorization. Under the FD&C Act, ENDS products are deemed tobacco products subject to FDA regulation.

Specifically, the FDA identified "new tobacco products" including VAAL EP4500 Disposable Kit 4500 Puffs (Cherry Coke), VAAL GLAZ 6500 Disposable Kit 6500 Puffs 13ml (Cotton Candy), and VAAL Tenk Disposable Kit 10000 Puffs 20ml Rechargeable (Lush Ice). These products are considered "new" because they were not commercially marketed in the U.S. before February 15, 2007, and lack the necessary premarket authorization order 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. Joyetech is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction, and products may