Shenzhen Kanger Technology Co. Ltd. d/b/a Kangertech – FDA Warning Letter, Sep 14, 2023

The FDA issued a Warning Letter to Shenzhen Kanger Technology Co. Ltd. d/b/a Kangertech on September 14, 2023, for marketing unauthorized new tobacco products. The FDA's Center for Tobacco Products reviewed Kangertech's website, https://www.kangertech.com, and found that Electronic Nicotine Delivery System (ENDS) products were offered for sale or distribution in the United States. These products are considered tobacco products under section 201(rr) of the FD&C Act, as amended to include nicotine from any source.

The identified violations include 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 the Kanger TOP EVOD Kit, Kanger T2 Replacement Coil – 5PK, and Kanger SOCC Replacement Coil – 5PK – 2.2OHMS, sold through retailers like LightFire Vapor (linked from Kangertech's site), were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Kangertech is required to submit a written response within