FDA WARNING_LETTER - Vapor Lab - October 07, 2021

The FDA issued a Warning Letter to Vapor Lab, identifying that the company manufactures and distributes e-liquid products, specifically "VAPOR LAB Lava dance 3% NIC 5% PG 92 VG e-liquid product," which are deemed tobacco products under the FD&C Act. The inspection and review of submissions revealed that this product is a "new tobacco product" as it was not commercially marketed in the U.S. before February 15, 2007.

The primary violation is the marketing of this new tobacco product without the required premarket 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) because the required notice or information under section 905(j) was not provided. These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Vapor Lab, a registered manufacturer with over 400 listed products, is required to ensure all its tobacco products comply with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The FDA requires a written response within 15 working days detailing actions taken to address violations, including