Blog The FDA and FMT regulation. (Mar 2024,

Michael Harrop

Active member
Jul 6, 2023

Response to FDA warning letter, proposal for FMT regulation, and some background of this project.

I wasn't planning on posting this yet, but the FDA letter has been publicly released and news organizations are already picking it up and contacting me about it, so I think it needs to be posted now. I may still make changes to it.
Format correct?
  1. Yes
A related forum discussion: Is human microbes getting shut down?

It includes discussion of the FDA Expanded Access program that allows patients to try non-licensed drugs:

As well as FDA Enforcement Discretion and EUAs (Emergency Use Authorization):

2015 paper discussing how to regulate FMT:
Ensuring the safe and effective FDA regulation of fecal microbiota transplantation One of the authors is from Openbiome.

Standards for fecal microbiota transplant: Tools and therapeutic advances (Mar 2024, meeting report). Includes commentary by an FDA employee.
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