The Food and Drug Administration (FDA) recently issued a warning letter to Safari Stem Cell, a Texas-based company that produces stem cell and platelet-rich plasma products for pets. The FDA expressed concerns about the claims made by Safari Stem Cell on their website and social media platforms, stating that the products are intended to treat various diseases and conditions in animals without proper approval.
Safari Stem Cell has been promoting its products as effective treatments for ailments such as arthritis, kidney disease, dry eye, and intervertebral disc disease in pets. However, the FDA pointed out that these tissue- and cell-based products should be considered animal drugs and are therefore subject to FDA regulation. The company does not have the necessary approvals or a “new animal drug application” to conduct research on these products.
During an inspection, the FDA found “significant deviations” from Current Good Manufacturing Practice (CGMP) regulations at Safari Stem Cell. These included a lack of written protocols to ensure product quality, failure to test for microorganisms, and inadequate monitoring of environmental conditions in an aseptic area. Despite receiving a notice about these violations in May 2023, the company continued to sell products on its website, leading to the issuance of the warning letter on April 5, 2024.
Steven Garner, the president of Safari Stem Cell, acknowledged the FDA’s concerns and stated that the company has taken steps to address them. These steps include building a new CGMP compliant lab, updating standard operating procedures, and working with consultants to ensure compliance. Garner emphasized that Safari Stem Cell has been operational for over a decade without prior FDA notices and expressed a willingness to cooperate with the agency.
Despite the warning letter, Garner reaffirmed the company’s commitment to treating fatal diseases in pets with stem cells and expressed confidence in the ability to continue with proper client consent. Safari Stem Cell submitted a formal response to the FDA and is awaiting a reply. Garner stated that the company has completed the required tasks outlined in their response but is still awaiting feedback from the FDA.
The FDA’s warning to Safari Stem Cell is part of the agency’s efforts to regulate unapproved regenerative medicine therapies, a campaign largely focused on human products in the past. These efforts encompass various birth tissue products and stem cell treatments, with the FDA requiring manufacturers to meet premarket approval criteria or conduct research under investigational new drug requirements since 2021.
The FDA’s warning to Safari Stem Cell underscores the importance of regulatory compliance in the development and marketing of stem cell therapies for pets. It serves as a reminder to companies in the regenerative medicine space to adhere to FDA guidelines and obtain necessary approvals to ensure the safety and efficacy of their products.
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