The FDA recently sent a warning letter to a Texas-based company, Safari Stem Cell, for their stem cell and platelet-rich plasma products meant for pets. The agency found that the company’s website and social media accounts contain statements indicating that their products are intended to treat a variety of diseases and conditions in animals without proper approval from the FDA. Safari Stem Cell claims that their products can treat ailments such as arthritis, kidney disease, dry eye, and intervertebral disc disease in pets, using tissue- and cell-based products derived from donated tissues from cats and dogs. However, the FDA stated that these products should be considered animal drugs, which require approval and are subject to FDA regulation.
During an inspection, the FDA also found significant deviations from Current Good Manufacturing Practice (CGMP) regulations at Safari Stem Cell. These included failing to have written protocols ensuring the quality of the products, neglecting to test for microorganisms, and not monitoring environmental conditions in an aseptic area, according to the warning letter. The FDA pointed out that the company had been previously notified about these violations in May 2023 and had assured the FDA that they would cease operations. However, the warning letter was issued on April 5, 2024, after Safari Stem Cell continued to sell and promote products on their website despite the earlier notice.
Steven Garner, the president of Safari Stem Cell, mentioned that the company has taken steps to address the FDA’s concerns, including constructing a new CGMP compliant lab and updating standard operating procedures and protocols. Garner expressed that the company has been operating for over a decade without any prior notice from the FDA, and they have differences of opinion but are collaborating with consultants on a way forward. He emphasized that Safari Stem Cell’s aim is to treat incurable fatal diseases of pet animals with stem cells and is confident that they can continue this practice with proper client consent. Following the warning letter, the company formally responded to the FDA and is currently awaiting a response from the agency.
This warning letter to Safari Stem Cell signifies the FDA’s efforts to regulate unapproved regenerative medicine therapies, although its focus has primarily been on human products. The FDA has been cracking down on noncompliant versions of regenerative therapies since 2021, including various birth tissue products and stem cell products. Manufacturers are now required to meet premarket approval criteria or conduct research under investigational new drug requirements to ensure compliance with FDA regulations.
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