FDA WARNING_LETTER - The Vaporium - March 19, 2021

The FDA issued a Warning Letter to The Vaporium, identifying that their e-liquid products, specifically "The Vaporium 6mg Red White and Blue 70/30 30 ML e-liquid," are tobacco products subject to FDA jurisdiction. The inspection and review of submissions revealed that this product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the manufacturing, sale, and distribution of this e-liquid product without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed 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 under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The Vaporium is a registered manufacturer with 19,860 listed products. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation dates for violative sales/distribution, and a plan for sustained compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or