FDA WARNING_LETTER - Austin Vapor - January 29, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Michael Laughlin, owner of Austin Vapor, on January 29, 2021, following a review of the website https://www.austinvapor.com. The FDA determined that e-liquid products, specifically "Austin Vapor – Chai Tea" and "Austin Vapor – Water Dragon," are manufactured and offered for sale or distribution in the United States.

These e-liquid products are classified as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these products are deemed 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 letter emphasizes the firm's responsibility, as a registered manufacturer with over 400 listed products, to ensure compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143).