The FDA Center for Tobacco Products issued a warning letter Feb. 14 to Sigelei Vape for products sold without authorization.
The letter appears to be the first warning issued to a Chinese manufacturer since Sept. 9, 2021, when the CTP ended a one-year period of non-enforcement against manufacturers selling vape products without FDA authorization.
The products specifically cited in the warning letter are the Sigelei Humvee 80 (an 80-watt mod) and the Sigelei 213 Fog Coil. The FDA also notes that the rules violated by the sales of those two products may also apply to other products sold by the company.
The Sigelei letter is being discussed by some in the vaping industry as a signal that the CTP is set to crack down on Chinese companies. But that isn’t necessarily the case. Sigelei has engaged in some activities that may set them apart from most Chinese hardware manufacturers.
Jim McDonald – Vaping360 – 2022-02-23.