FDA WARNING_LETTER - Ardent Animal Health, LLC - September 13, 2024

The FDA inspected Ardent Animal Health's facility at 220 Bellaire Drive, Nicholasville, KY, from September 10-13, 2024. The FDA determined that Ardent Animal Health is marketing unapproved new animal drugs, Acti-Stem Therapy and PureVet PRP, which are considered drugs under section 201(g)(1) of the FD&C Act due to their intended use in diagnosing, curing, mitigating, treating, or preventing disease in animals, or affecting animal body structure/function.

Acti-Stem Therapy (stromal vascular fraction with platelet-rich plasma) and PureVet PRP (platelet-rich plasma) are for autologous use in dogs and cats. The FDA cited numerous claims from Ardent Animal Health's website, social media, and phone application, demonstrating these products' intended drug uses, such as "rebuild and regenerate cartilage," "repair tissues," and treating conditions like osteoarthritis, hip dysplasia, and wound healing.

These products are classified as new animal drugs under section 201(v) of the FD&C Act because they are not generally recognized as safe and effective. To be legally marketed, new animal drugs require an approved new animal drug application, conditional approval, or index listing, which these products lack. Therefore, they are unsafe under section 512(a) and adulterated under section 501(a)(5) of the