The FDA recently 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 a result of the company’s claims on their website and social media accounts that their products can treat various diseases and conditions in animals. The FDA pointed out that these products should be considered animal drugs, which require approval and regulation by the agency. The company was found to lack proper approval and did not have a “new animal drug application” approved to conduct research.
During an inspection, the FDA discovered significant deviations from CGMP regulations in Safari Stem Cell’s manufacturing processes. These included the lack of written protocols to ensure the quality of the products, failure to test for microorganisms, and failure to monitor environmental conditions in an aseptic area. These deviations raise concerns about the safety and effectiveness of the products being produced by the company.
Despite the violations identified by the FDA, the president of Safari Stem Cell, Steven Garner, stated that the company has made efforts to address the agency’s concerns. This includes building a new CGMP compliant lab, updating standard operating procedures, and protocols. However, Garner’s response seems to downplay the severity of the violations and implies that the company has been operating without issues for over 10 years. This raises questions about the company’s commitment to compliance with FDA regulations.
Despite receiving a notice from the FDA in May 2023 to cease operations due to violations, Safari Stem Cell continued to promote and sell products on its website. The warning letter issued in April 2024 highlights the company’s disregard for FDA regulations and raises concerns about the safety of the products being sold to pet owners. The company’s decision to defy the FDA’s directive reflects a lack of respect for regulatory authority and raises doubts about its commitment to consumer safety.
The FDA’s warning to Safari Stem Cell is part of its broader efforts to crack down on unapproved regenerative medicine therapies, not only for pets but also for humans. The agency has been focusing on products like birth tissue products and stem cell products that have not met premarket approval criteria. By requiring manufacturers to meet these criteria or conduct research under investigational new drug requirements, the FDA is aiming to ensure the safety and effectiveness of regenerative medicine products for both humans and animals.
The FDA’s warning letter to Safari Stem Cell highlights the need for stricter regulation of stem cell and PRP products for pets. The violations identified by the agency, along with the company’s lack of compliance and continued promotion of unapproved products, raise serious concerns about the safety and efficacy of these treatments for animals. Moving forward, it is essential for companies like Safari Stem Cell to prioritize FDA compliance and consumer safety to ensure the well-being of pets receiving regenerative medicine therapies.