Silver Lease, LLC – FDA Warning Letter, Dec 14, 2023

The FDA issued a Warning Letter to Dan Keen concerning the manufacture and distribution of veterinary products for aquarium fish, specifically Fishbiotic Cephalexin, Doxycycline, and SMZ/TMP. An August 2023 review of distributor websites revealed these products are marketed with claims establishing them as animal drugs under section 201(g)(1)(B) of the FD&C Act. The FDA found these products to be unapproved new animal drugs under section 201(v), lacking the necessary approval, conditional approval, or index listing required by sections 512, 571, or 572. Consequently, they are considered unsafe and adulterated under sections 512(a) and 501(a)(5). Furthermore, the drugs are misbranded under section 502(o) because the manufacturing facility is not registered with FDA, and the products are not drug listed, violating sections 510(b) and (j). Introducing these unapproved, adulterated, and misbranded drugs into interstate commerce is prohibited by section 301(a). The FDA expressed particular concern due to the products containing medically important antimicrobials, raising public health concerns regarding antimicrobial resistance. The firm must respond within fifteen working days detailing corrective actions, recurrence prevention, and supporting documentation, or explain any delays. Failure to comply may result in legal action, including seizure or injunction, potentially affecting all unapproved/unindexed products. The letter suggests obtaining index listing or approval as a path to legal marketing.