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# Additional FMT Safety Protections Needed: FDA
- URL: https://www.fdaweb.com/additional-fmt-safety-protections-needed-fda/
- Published: 2020-04-08T12:00:00.000Z
- Updated: 2026-09-14T16:10:23.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5146524

FDA says it has determined that additional safety protections are needed for any investigational use of fecal microbiota for transplantation (FMT), whether under an IND on file with the agency or FDA’s enforcement discretion policy. A 4/6 [announcement](https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/information-pertaining-additional-safety-protections-regarding-use-fecal-microbiota-transplantation-0?ref=fdaweb.com) about the recommended new safety steps follows a 3/12 [announcement](https://www.fdaweb.com/fecal-microbiota-for-transplant-safety-alert/) about the potential risk of serious or life-threatening infections with the use of FMT. The agency said it suspected the infections were due to the transmission of pathogenic organisms from FMT products supplied by a U.S.-based stool bank company. The company later identified itself as OpenBiome, Cambridge, MA.

FDA says it has communicated with OpenBiome and individually with IND holders for investigational FMT to underscore the need for these additional protections: 

- testing FMT donor stool by nucleic acid amplification tests (NAAT) for enteropathogenic *Escherichia coli* (EPEC) and Shigatoxin-producing *Escherichia coli*(STEC) to exclude the use of stool that tests positive for either EPEC or STEC; and
- testing all FMT products currently in storage for which the donor has not undergone stool testing for both EPEC and STEC using NAAT.

The notice says that patients considering FMT to treat *C. difficile* should speak to their healthcare provider to understand the potential risks associated with the product’s use.