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Ardent Animal Health, LLC was warned for marketing two unapproved new animal drug products—Acti-Stem Therapy (stromal vascular fraction with platelet-rich plasma) and PureVet PRP (platelet-rich plasma)—without FDA approval, in violation of the Federal Food, Drug, and Cosmetic Act. During an FDA inspection of the company's Kentucky facility in September 2024, regulators identified disease treatment and prevention claims on the company's website, social media pages (Facebook and Instagram), and mobile application that established these regenerative therapy products as drugs intended to diagnose, cure, mitigate, treat, or prevent disease in dogs and cats. The company's marketing of these cell and tissue-based products for autologous use violated the prohibition against introducing unapproved new animal drugs into interstate commerce.