FDA WARNING_LETTER - Vapor Lab - Cleburne - October 07, 2021

The FDA issued a Warning Letter to DJ Wooldridge, operating as Vapor Lab, for manufacturing and distributing e-liquid products, specifically "VAPOR LAB Tigers Blood 3 NIC 60ml," without the required premarket authorization. The FDA determined these e-liquid products are "tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The "VAPOR LAB Tigers Blood 3 NIC 60ml" product is classified as a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007. Consequently, it requires a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act or an exemption, neither of which is in effect. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information.

The FDA cited prohibited acts under section 301(k) for holding for sale an adulterated or misbranded product, and section 301(p) for failing to provide a required report. Vapor Lab is a registered manufacturer with over 400 listed products. The FDA emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject