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The FDA and FMT (fecal microbiota transplant) regulation

fmt fda regulation fecal transplant

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#1 MaximilianKohler

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Posted 14 March 2024 - 07:56 PM


I'm a patient who has been on disability for CFS, IBS, and more for a few decades. Here's a 10-minute video covering the microbiome, FMT, and my history and efforts:



I created this non-commercial database of microbiome research https://humanmicrobiome.info, and later on I founded https://www.humanmicrobes.org/ to try to find high-quality stool donors for FMT. I've screened over a million stool donor applicants at this point. Unfortunately, I haven't found any that meet the ideal criteria. You can read more on the blog https://www.humanmicrobes.org/blog.

I recently received a warning letter from the FDA which puts the future of the Human Microbes project in jeopardy. I just posted two new blogs about it:

I wanted to post here to see if anyone has any advice about what could be done. Perhaps a letter-writing/petition campaign to the FDA could be organized?


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