The Risks of Unapproved Stem Cell and Platelet-Rich Plasma Products for Pets

The Risks of Unapproved Stem Cell and Platelet-Rich Plasma Products for Pets

Recently, the Food and Drug Administration (FDA) issued a warning letter to Safari Stem Cell, a company in Texas that produces stem cell and platelet-rich plasma products for pets. The FDA expressed concern over the claims made on the company’s website and social media platforms, stating that the products are being marketed to treat a variety of diseases and conditions in animals without proper approval.

Unapproved Treatments for Pets

Safari Stem Cell has been touting its products as treatments for ailments such as arthritis, kidney disease, dry eye, and intervertebral disc disease in pets. These tissue- and cell-based products are derived from donated tissues from cats and dogs, making them subject to FDA regulations as animal drugs. However, the company lacks the necessary approval and “new animal drug application” needed to conduct research.

During an inspection, the FDA found “significant deviations” from Current Good Manufacturing Practice (CGMP) regulations at Safari Stem Cell. These violations included the absence of written quality assurance protocols, failure to test for microorganisms, and neglecting to monitor environmental conditions in an aseptic area. Despite a previous notice from the FDA in May 2023, the company continued to sell its products, prompting the warning letter in April 5, 2024.

Company Response

Steven Garner, the president of Safari Stem Cell, stated that the company has taken steps to address the FDA’s concerns. These efforts include the construction of a new CGMP compliant lab and updating standard operating procedures and protocols. Garner maintains that the company has operated for over a decade without prior FDA warnings and is cooperating with consultants on next steps.

Garner emphasized the company’s mission to treat fatal diseases in pets with stem cells, insisting that they should be allowed to continue this practice with proper client consent. Following the FDA warning letter, Safari Stem Cell submitted a formal response to the agency and is awaiting a reply. The company has completed tasks outlined in its initial response but is still awaiting feedback from the FDA.

FDA Crackdown

This incident reflects the FDA’s broader efforts to regulate unapproved regenerative medicine therapies, primarily focusing on human products. The agency has been targeting noncompliant products like various birth tissue products and stem cell therapies since 2021, requiring manufacturers to meet premarket approval criteria or adhere to investigational new drug requirements.

The warning issued to Safari Stem Cell highlights the risks associated with unapproved stem cell and platelet-rich plasma products for pets. It underscores the importance of FDA regulations in ensuring the safety and effectiveness of treatments for animals. It is crucial for companies in the regenerative medicine industry to comply with regulatory standards to protect the health and well-being of pets receiving these treatments.

Health

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