FDA WARNING_LETTER - Vet Cellect Bio Products, LLC

On October 4, 2017, the FDA issued Warning Letter CMS # 537739 to Vet Cellect LLC, specifically addressing the firm's marketing of its cell-based, regenerative therapy product, ExCellR8?. The FDA reviewed the company's website, www.vetcellect.com, and determined that ExCellR8? is intended for use in the mitigation, treatment, or prevention of diseases in animals, classifying it as a drug under section 201(g)(1)(B) of the FD&C Act.

The letter cites several statements from the website demonstrating this intended use, including claims for controlling irritation and inflammation in equine joints, promoting natural equine health, supporting healthy joint and cartilage function, and treating common athletic injuries.

The FDA determined that ExCellR8? is an unapproved new animal drug, as defined by section 201(v) of the FD&C Act, because it is not generally recognized as safe and effective for its stated uses. Consequently, ExCellR8? is considered unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act, as it lacks an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572.

Vet Cellect LLC is required to