Fecal Microbiota Transplantation (FMT) & Regulations

Scientists still don’t know what it means to have “good stools” — donor material that promotes an efficient anticancer response — says David Pinato, a consulting oncologist and head of the developmental therapeutics research programme at Imperial College London.
Erdman 2022 Nature 607: 436-439

Identifying the ideal stool for donation might not be a matter of which microbes it holds, but rather what they do, says Wargo
Erdman 2022 Nature 607: 436-439

The agency allows Fecal Microbiota Transplantation (FMT) without approval under a unique “enforcement discretion” policy
Garber 2020 Nat. Rev. Drug Discov. 19: 655–656

Fecal microbiota for transplantation (FMT) is being studied as a potential intervention for numerous conditions. The regulation of FMT by the FDA is discussed along with FMT donor screening and manufacturing considerations. The FDA is committed to ensuring that FMT products can be safely tested in clinical trials.
Carlson Jr. 2020

Recent incidents, including a death and a case of septicemia following FMT, underscore the urgent need for comprehensive guidelines to ensure safety and efficacy. A 24-member expert group was convened to address this need. Utilizing a modified Delphi approach, the group engaged in online voting and in-person meetings to formulate recommendations. These were grounded in both evidence and expert opinion, with leadership from Australian experts and contributions from an international delegate.
Haifer et al. 2020 Gut 69: 801-810

The group concentrated on several key areas:

• Donor Selection: Establishing rigorous standards for screening donors to ensure safety.


• Clinical Indications: Defining the conditions and scenarios where FMT is appropriate.


• FMT Centre Requirements: Setting standards for the facilities where FMT is produced and administered.

Haifer et al. 2020 Gut 69: 801-810

These guidelines serve as a comprehensive resource for clinicians, researchers, and policymakers involved in the use of FMT. By adhering to these standards, the safety and effectiveness of FMT can be enhanced, paving the way for its broader application in medical practice.
Haifer et al. 2020 Gut 69: 801-810

FDA regulates microbiota transplants as a biologic and as a drug
Allegretti et al. 2019 Lancet 394: 420-31

Fecal Microbiota Transplantation (FMT) could be more similar to a tissue or organ transplant
Allegretti et al. 2019 Lancet 394: 420-31

Fecal Microbiota Transplantation (FMT) is considered an Investigational New Drug (IND)
Allegretti et al. 2019 Lancet 394: 420-31

Fresh Fecal Material Directly from a Donor Would Be Considered Practice of Medicine
Allegretti et al. 2019 Lancet 394: 420-31

Material from stool banks falls in between and could logically be regulated in the manner of other banked tissues, such as stem cells or blood
Allegretti et al. 2019 Lancet 394: 420-31

Regulatory challenges remain one of the most complicated issues surrounding Fecal Microbiota Transplantation (FMT) in both the USA and Europe
Allegretti et al. 2019 Lancet 394: 420-31

Stools Consisting of Defined Bacterial Consortia Would Be More Appropriately Regulated within the Traditional Drug Pathway
Allegretti et al. 2019 Lancet 394: 420-31

There isn't a standardized method for selecting a donor for FMT, but there's a general agreement on the necessity of establishing one.
Borody et al. 2013 Curr Gastroenterol Rep 15: 337

Donors are typically evaluated based on their bowel movement health using the Bristol stool chart, as well as for any communicable diseases, recent travel history, and antibiotic history.
Marotz & Zarrinpar 2016 Yale J Biol Med. 89: 383–388

see also:
Adverse Events / Safety & Fecal Microbiota Transplantation (FMT)
Application & Fecal Microbiota Transplantation (FMT)
Fecal Microbiota Transplantation (FMT)