FDA WARNING_LETTER - Hubbly Bubbly LLC, d/b/a Trifecta Tobacco - November 16, 2023

On November 16, 2023, the FDA issued a Warning Letter to Hubbly Bubbly LLC, d/b/a Trifecta Tobacco, following a review of inspection records. The FDA determined that the company manufactures and distributes hookah tobacco products, which are subject to FDA jurisdiction as "tobacco products" under the FD&C Act, including those containing nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product TRIFECTA PEPPERMINT SHAKE 1000g was cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

This renders the product adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and 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 under section 905(j). The introduction of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a) and 301(p)