FDA WARNING_LETTER - Vapor State LLC - July 16, 2021

The FDA issued a Warning Letter to STR8VAPE, identifying that their e-liquid product, "Vapor State E-Juice Tahitian Vanilla 3mg," is a new tobacco product lacking required premarket authorization. Under section 201(rr) of the FD&C Act, e-liquids are considered tobacco products subject to FDA jurisdiction since August 8, 2016.

A "new tobacco product" is defined as one not commercially marketed in the U.S. as of February 15, 2007, or a modified product marketed after this date. The identified product was not commercially marketed by the February 15, 2007, predicate date and lacks an FDA 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 because the required notice or information under section 905(j) was not provided.

These violations constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. STR8VAPE, a registered manufacturer with over 340 listed products, is responsible for ensuring compliance. Failure to address these issues may result in regulatory actions,