FDA WARNING_LETTER - Wizman Limited d/b/a Wizvapor - November 16, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Wizvapor on November 16, 2022, after reviewing their website, https://www.wizvapor.com. The FDA determined that Wizvapor manufactures and offers for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products, specifically Puff Boy, Mini-Beeper 2.0, and Walkie Vape, which are considered tobacco products under section 201(rr) of the FD&C Act.

These products are deemed "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notices or information were not provided under section 905(j).

The FDA expressed particular concern that the product labeling and/or advertising for these ENDS products imitate children’s toys and gaming products, likely promoting youth use. The packaging is also designed to conceal the product's nature as a tobacco product, potentially allowing youth to carry them without detection.

Wizvapor is required to submit a written response within 15