FDA WARNING_LETTER - Shenzhen GreenSound High-Tech Co., LTD d/b/a Vaporlax - January 27, 2023

The FDA's Center for Tobacco Products issued a Warning Letter to Vaporlax on January 27, 2023, after reviewing their website, vaporlax.com. The FDA determined that Vaporlax manufactures and offers for sale or distribution in the United States electronic nicotine delivery systems (ENDS) products that are considered "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, products like "Cool Mint by Vaporlax," "Mango Ice by Vaporlax," "Rainbow Mix by Sirius (Vaporlax)," and "Lemon Bar by Sirius (Vaporlax)" were identified as new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007. These products lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

While Vaporlax submitted Premarket Tobacco Product Applications (PMTAs) for other products, the specific products listed in the Warning Letter were not included in those applications and lack premarket authorization. The FDA stated that all new tobacco products on the market without the required premarket authorization are marketed unlawfully and are subject to enforcement action, including civil money penalties, seizure, and/or