Recently, the FDA issued a warning letter to Safari Stem Cell, a company based in Texas that produces stem cell and platelet-rich plasma products for pets. The warning was in response to claims on the company’s website and social media accounts suggesting that their products could treat a variety of diseases and conditions in animals without proper approval from the FDA. Safari Stem Cell purported that their products could help with diseases like arthritis, kidney disease, dry eye, and intervertebral disc disease in pets. These tissue- and cell-based products, derived from donated tissues from cats and dogs, should be considered animal drugs, according to the FDA. However, the company lacks approval from the FDA to produce or sell these products legally, and they do not have a “new animal drug application” approved to conduct research.
During an inspection, the FDA found “significant deviations” from Current Good Manufacturing Practice (CGMP) regulations at Safari Stem Cell’s facilities. These deviations included a lack of written protocols to ensure product quality, failure to test for microorganisms, and negligence in monitoring environmental conditions in an aseptic area. Despite receiving a notice about these violations in May 2023, which led the company to promise to stop operations, Safari Stem Cell continued to promote and sell products on its website. This disregard for FDA regulations prompted the warning letter issued on April 5, 2024.
Steven Garner, the president of Safari Stem Cell, stated that the company has taken steps to address the concerns raised by the FDA. These measures include building a new CGMP compliant lab, updating standard operating procedures and protocols, and working with consultants to ensure compliance with FDA regulations. Garner claimed that the company was aware of most of the allegations and has made efforts to rectify them. He expressed confidence in the company’s ability to continue providing stem cell treatments for pets with proper client consent, emphasizing the company’s goal of treating untreatable fatal diseases in animals.
Following the FDA warning letter, Safari Stem Cell sent a formal response to the agency, detailing the steps taken to address the violations. Garner mentioned that the company is awaiting a response from the FDA, having submitted their initial response within the required time frame and completing the tasks specified by the agency. Despite the ongoing dialogue with the FDA, Garner remains hopeful that Safari Stem Cell will be able to continue its operations and provide innovative treatments for pets.
While the FDA’s focus has primarily been on unapproved regenerative medicine therapies for humans, Safari Stem Cell’s case highlights the agency’s increasing scrutiny of veterinary products. The FDA has been working to address noncompliant stem cell products, including various birth tissue products and other stem cell therapies, since 2021. Manufacturers of such products are now required to meet premarket approval criteria or conduct research under the FDA’s investigational new drug requirements to ensure compliance with regulatory standards.
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