FDA WARNING_LETTER - Guangdong Sigelei Electronic Technology Co., Ltd. d/b/a Sigelei Vape, Inc. - February 22, 2022

The FDA issued a Warning Letter to Ying Liu and Tom Li of Sigelei on February 14, 2022, following a review of their website, sigelei.com. The FDA determined that Sigelei manufactures and offers for sale or distribution in the U.S. Electronic Nicotine Delivery Systems (ENDS) products, which are regulated as tobacco products under the FD&C Act.

The core violation is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the Sigelei Humvee 80 and Sigelei 213 Fog Coil ENDS products were identified as new tobacco products not commercially marketed in the U.S. before February 15, 2007, and lacking an FDA marketing authorization order. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although Sigelei submitted a Premarket Tobacco Product Application (PMTA) (STN PM0001221) on September 7, 2020, it received a Refuse to Accept determination on February 5, 2021, covering six products. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction.

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