FDA WARNING_LETTER - Vapewear, LLC - April 27, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Scott Arnel after reviewing vapewearlabs.com and identifying the Vapewear vWaTch Starter Kit ENDS product as a tobacco product offered for sale without required marketing authorization. This product is considered a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j). The failure to provide such a report is also a prohibited act under section 301(p). FDA expressed significant concern that the product's smartwatch-like design is likely to appeal to children and conceal tobacco use. The firm must promptly correct all violations, discontinue violative labeling, advertising, sale, and distribution, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Non-compliance may lead to civil money penalties, seizure, injunction, and import refusal.