FDA WARNING_LETTER - Wizman Limited d/b/a Wizvapor - April 27, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Wizman Limited after reviewing their website, wizman710.com, which offers Electronic Nicotine Delivery Systems (ENDS) products for sale in the U.S. The FDA determined that the "Wizman Puff Boy Mod ENDS product" is a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007.

The product is cited as adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act for lacking the required premarket marketing authorization order under section 910(c)(1)(A)(i) or an exemption. The failure to provide a report under section 905(j) is also a prohibited act under section 301(p).

The FDA expressed particular concern that the Wizman Puff Boy Mod's design imitates handheld video gaming products, like Nintendo's Game Boy, which are appealing to minors. This design could conceal the product's nature as a tobacco product from adults, potentially encouraging unlawful sales and increasing youth ENDS use.

Wizman Limited is required to submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and advertising, and