V8P Juice International LLC – FDA Warning Letter, Aug 8, 2019

The FDA issued a Warning Letter to V8P Juice International LLC on August 8, 2019, following a review of submissions and inspection records. The FDA determined that V8P Juice International LLC manufactures and distributes e-liquid products, specifically V8P Saltz Blonde Bombshell, V8P Saltz Mami Merengue, V8P Saltz Port Master, V8P Saltz Last Samurai, V8P Saltz Cowboy Killer, and V8P Saltz Caribbean Don, which are considered tobacco products under the FD&C Act.

These products are deemed adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) because they are "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007, and lack the required FDA marketing authorization order under section 910(c)(1)(A)(i). Additionally, they are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) due to the failure to provide required notice or information as per section 905(j).

The introduction of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section