The FDA issued a warning letter to Human Microbes for selling products containing human fecal matter without the necessary approvals. Proper regulatory processes, including a biologics license application, are essential for introducing and distributing such therapies.
Health Canada confirms Fecal Microbiota Therapy (FMT) should be used only in authorized clinical trials or for specific conditions like recurrent Clostridium difficile. Human Microbes claimed promising results for various conditions but lacked essential FDA approvals.
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