FDA warns company selling products with human fecal matter without approval
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The United States Food and Drug Administration has issued a warning letter to a company that appears to sell products containing human fecal matter without approval from the agency.
In March, the FDA wrote to Human Microbes, a company advertising itself as "the world's largest, highest quality stool donor bank" for fecal microbiota therapy transplants, after reviewing its website a month prior.
This type of therapy should only be used in the context of an authorized clinical trial, or to treat patients with recurrent Clostridium difficile, also known as C. difficile, a bacteria that causes diarrhea and intestinal conditions, like colon inflammation, the agency said.
Per Human Microbes' website, the therapy yields "promising results in clinical trials" to treat other conditions, such as irritable bowel syndrome, Parkinson's disease, multiple sclerosis and mental health disorders like depression and anxiety, among others.
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The United States Food and Drug Administration has issued a warning letter to a company that appears to sell products containing human fecal matter without approval from the agency.
In March, the FDA wrote to Human Microbes, a company advertising itself as "the world's largest, highest quality stool donor bank" for fecal microbiota therapy transplants, after reviewing its website a month prior.
This type of therapy should only be used in the context of an authorized clinical trial, or to treat patients with recurrent Clostridium difficile, also known as C. difficile, a bacteria that causes diarrhea and intestinal conditions, like colon inflammation, the agency said.
Per Human Microbes' website, the therapy yields "promising results in clinical trials" to treat other conditions, such as irritable bowel syndrome, Parkinson's disease, multiple sclerosis and mental health disorders like depression and anxiety, among others.
This is a really cool idea that showed a lot of promise in early trials. But yes, it should probably be FDA regulated.
The idea is to transport bacteria from people with healthy GI bacteria populations to people that have GI bacteria problems. The original implementation I remember was really simple: donor poop was dried out in a centrifuge and then packed straight into capsules that were swallowed by the donatee.
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This is a really cool idea that showed a lot of promise in early trials. But yes, it should probably be FDA regulated.
The idea is to transport bacteria from people with healthy GI bacteria populations to people that have GI bacteria problems. The original implementation I remember was really simple: donor poop was dried out in a centrifuge and then packed straight into capsules that were swallowed by the donatee.
Actually, it is helpful for many people if they pick the right donor and ensure the material is tested. It is a really complicated area. The FDA shouldn't be that strict. I know the owner of that stool bank is doing a great job trying to convince Robert Kennedy to promote more Fecal Transplants in the US.
