FDA WARNING_LETTER - Badfish Drip Co - November 09, 2021

The FDA issued a Warning Letter to Badfish Drip Co. on November 9, 2021, following a review of submissions and inspection records. The FDA determined that Badfish Drip Co. manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act and subject to FDA jurisdiction.

The core violation identified is the manufacturing, sale, and distribution of "new tobacco products" without the required premarket authorization. Specifically, the products BADFISH Drip Co. SASSI ASS FLOAT 03MG 60ML and BADFISH Drip Co. JACK FROST 03MG 60ML were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide required reports under section 905(j) is also cited as a prohibited act.

Badfish Drip Co. is a registered manufacturer with over 1,300 listed products. Their Premarket Tobacco Product Application (PMTA), STN PM0002341, submitted on September 9, 2020, received a Marketing Denial Order on September 15, 2021, covering 1,