Magma Holding Inc. d/b/a EightVape – FDA Warning Letter, Jun 25, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Yuxiang Gao, Qian Xu, and George Chang, following a review of eightvape.com, which revealed the sale and distribution of electronic nicotine delivery system (ENDS) products in the United States. These products, specifically Funky Republic Ti7000 Disposable Vape and Lost Mary MO5000 Disposable Vape, are considered 'new tobacco products' under section 910(a) of the FD&C Act because they were not commercially marketed as of February 15, 2007. The FDA determined that these products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these unauthorized products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the necessary notice or information under section 905(j) was not provided. The firm is required to submit a written response within 15 working days, detailing actions taken to address these violations, including discontinuing the sale and distribution of the violative products, and outlining a plan for maintaining compliance with the FD&C Act. Failure to comply may result in regulatory actions such as civil money penalties, seizure, injunction, or detention of imported products.