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Desert Defense, LLC was warned for marketing unapproved new animal drug products, including "Desert Defense Original Formula" and "SuperBo Wellness Formula," without FDA approval in violation of the Federal Food, Drug and Cosmetic Act. The company made disease claims on its website and social media platforms stating the products provided "prevention or active cases of Valley Fever" and other therapeutic benefits, thereby establishing the products as drugs requiring approval before distribution. The FDA determined these products were intended for diagnosis, cure, mitigation, treatment, or prevention of disease in animals, making their introduction into interstate commerce without approval a prohibited act.