FDA WARNING_LETTER - Artisan Vapor Company - May 27, 2025

On May 22, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Artisan Vapor Company for selling and distributing e-liquid products without required marketing authorization. The FDA determined that the product "NOMS 100 GUAVA GRAPEFRUIT LIMEAIDE 3MG/ML" is a "new tobacco product" under section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)) because it was not commercially marketed in the U.S. as of February 15, 2007.

This product lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) and is not exempt. Consequently, it is deemed 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)) because required information under section 905(j) was not provided.

The letter emphasizes that all new tobacco products, including those containing nicotine from any source as per