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Five Leaf Pet Botanicals, Inc. marketed unapproved new animal drugs including "Canine Heart Tonic," "Hawthorne Tincture," "Hepara-Cleanse," and "Rena-Cleanse" for treating diseases in dogs such as congestive heart failure, valvular disease, and kidney/liver conditions without FDA approval. The company violated the Federal Food, Drug, and Cosmetic Act by distributing these products across multiple websites (caninehearthealth.com, caninekidneyhealth.com, canineliverhealth.com, and fiveleafpetbotanicals.com) and in bundled packages while making disease treatment claims that classified them as drugs requiring pre-market approval. The FDA Center for Veterinary Medicine determined the products were intended for diagnosis, cure, mitigation, treatment, or prevention of disease and/or to affect animal body structure or function, making their introduction into interstate commerce unlawful.