FDA WARNING_LETTER - Super Vape'z - April 05, 2021

The FDA issued a Warning Letter to Super Vape’z, identifying that their e-liquid products, specifically "SUPER VAPE’Z Premium E-liquid Apple Mango 60ml 12mgNic," are tobacco products subject to FDA regulation. The letter states 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/or distribution of this e-liquid product without the required premarket marketing authorization order from the FDA, as mandated by 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.

Super Vape’z, a registered manufacturer with over 700 listed products, is required to ensure compliance. The FDA demands a written response within 15 working days detailing corrective actions, including the discontinuation date of violative sales/distribution, and a plan for ongoing compliance. Failure to address these violations may result in regulatory actions