FDA Warns Company Over Laminitis Treatment Claims

The United States Food and Drug Administration has asked Equine Podiatry Solutions to change marketing language on one of its websites and its social media regarding its laminitis treatment.

In a warning letter sent to the company's CEO May 16 and posted to the FDA website June 16, the FDA raises concerns about the "marketing of unapproved veterinary products for the treatment of disease in animals, including but not limited to desmosphyrine at www.beatlaminitis.com in October, November, and March. The warning letter also raised concerns about company claims in its social media.

"The claims on your website and social media websites establish that your desmosphyrine product is a drug under…the Federal Food Drug and Cosmetic Act because it is intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals," the FDA warning letter said. "As explained further below, this product is an unapproved new animal drug and introducing or delivering this product for introduction into interstate commerce violates the FD&C Act."

Equine Podiatry Solutions CEO Derrick Cooke noted that the marketing language that the FDA issued the warning on was quickly addressed. Cooke said the company is currently working out the issue with the FDA, supporting its position that it is in compliance with the FDA.

The letter went on to cite a number of examples where the FDA had concerns about the portrayal of desmosphyrine. The letter asks that the company investigate the causes of any violations and prevent their recurrence or occurrence of other violations.

This story was updated to clarify some language and add a response from Equine Podiatry Solutions.