FDA WARNING_LETTER - Shenzhen Innokin Technology Co., Ltd. - May 25, 2023

On May 25, 2023, the FDA issued a Warning Letter to Tao Cui of Shenzhen Innokin Technology Co., Ltd., following a review of their website, innokin.com. The FDA determined that the company offers Electronic Nicotine Delivery System (ENDS) products for sale or distribution in the United States, which are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Specifically, products like "Esco Bars H2O 6000 – Disposable – Mango Lassi" and "Esco Bars H20 6000 – Disposable – Strawberry Milkshake," distributed through retailers like MadVapes, were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. This renders the products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires Shenzhen Innokin Technology Co., Ltd. to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and outlining a plan for future compliance. Failure to