FDA WARNING_LETTER - Kai’s Virgin Vapor - April 16, 2024

On April 5, 2024, the FDA issued a Warning Letter to Annette Rogers regarding e-liquid products manufactured and sold on kaisvirginvapor.com. The FDA's Center for Tobacco Products determined that "Celestial Honeydew" and "Fresh Thai Mango" e-liquid products are "new tobacco products" under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) because they contain nicotine and are intended for human consumption.

These products are deemed "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007. They lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) and are not exempt. Consequently, they are adulterated under section 902(6)(A) (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) (21 U.S.C. § 387c(a)(6)) due to the absence of required information under section 905(j) (21 U.S.C.