FDA WARNING_LETTER - Global Vapery LLC and Infinite Vapor LLC - January 25, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to Gavin Rydell, Bijan Hamzehpour, Kimberly Lee, and Beecher Vaillancourt, associated with Global Vapery, regarding the sale of unapproved e-liquid products. The FDA reviewed the website https://globalvapery.com and determined that e-liquid products, specifically "Fu Man Brews – Charles Dinsmore RESERVE 60mL 6mg" and "Fu Man Brews – Charles Dinsmore RESERVE 60mL 12mg," are being manufactured and offered for sale in the U.S. These 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 identified e-liquid products lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Although the firm is a registered manufacturer with over 2,000 active products listed with FDA and submitted a Premarket Tobacco Product Application (PMTA) (STN PM0003515) on September 8, 202