FDA WARNING_LETTER - Half Moon Mods LLC - March 10, 2022

On March 10, 2022, the FDA issued a Warning Letter to Half Moon Mods LLC, identifying violations related to the manufacturing and distribution of electronic nicotine delivery system (ENDS) products. The FDA determined that Half Moon Mods LLC manufactures and distributes ENDS products, which are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation cited is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products "TFV16 Drip Tips" and "Caramel Corn TFV8/12 Drip Tips" were identified as new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lacked FDA marketing authorization orders. This renders these products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notices or information were not provided under section 905(j).

The introduction of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, and failure to provide required reports is prohibited under section 301(p). Half Moon Mods LLC is a registered manufacturer with over 7,200 listed products. The FDA emphasizes