FDA WARNING_LETTER - EightCig LLC d/b/a EightCig Distribution - April 27, 2020

The FDA Center for Tobacco Products issued a Warning Letter to EightCig LLC after reviewing their websites, eightcig.com and eightvape.com, which offer electronic nicotine delivery systems (ENDS) products for sale in the U.S. The FDA determined that the Wizman Puff Boy 200W Mod ENDS product is a "new tobacco product" as it was not commercially marketed before February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j). The FDA expressed particular concern that the product's design, imitating handheld video games, is likely to appeal to children and promote use by minors, potentially encouraging unlawful sales. EightCig LLC is required to submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for compliance. Failure to comply may result in civil money penalties, seizure, injunction, or refusal of admission for imported products.