FDA WARNING_LETTER - Vapor Source Inc. - October 22, 2021

The FDA issued a Warning Letter to Vapor Source Inc. after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. Specifically, VAPOR SOURCE CARAMEL VANILLA 18mg/ml 120ml, VAPOR SOURCE CHEESECAKE 18mg/ml 120ml, VAPOR SOURCE BERRY CHERRY 18mg/ml 120ml, and VAPOR SOURCE COLORADO SUNRISE 18mg/ml 120ml e-liquids were commercially marketed after February 15, 2007, without FDA marketing authorization orders or exemptions. This renders these products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide required reports under section 905(j) is also a prohibited act.

Vapor Source Inc. is a registered manufacturer with over 800 products listed. While Premarket Tobacco Product Applications (PMTAs) were submitted for some products (STNs PM0003494, PM0003451, PM0004326), STN PM00