HiggyCigs LLC d/b/a Viral Vapes – FDA Warning Letter, Nov 30, 2023

The FDA issued a Warning Letter to HiggyCigs LLC d/b/a Viral Vapes on November 30, 2023, based on an inspection. The company manufactures and distributes e-liquid products, including "Hula Fruits," which are considered tobacco products under the FD&C Act, specifically section 201(rr) (21 U.S.C. § 321(rr)), due to containing nicotine.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization. The FDA determined that "Hula Fruits" and other e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)).

Consequently, these products are 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 notices or information under section 905(j) (21 U.S.