Fecal Microbiota Products
The human intestinal tract contains millions of microorganisms, often referred to as the “gut flora," or "gut microbiome." Many of the microorganisms that live in the gut are also found in stool. Fecal microbiota products are prepared from human fecal matter (stool) donated by healthy individuals and are administered to another individual. The administration of fecal microbiota products is thought to facilitate restoration of the gut flora.
Fecal microbiota products that are used to diagnose, prevent, treat, or cure a disease or condition in humans are biological products and the Center for Biologics Evaluation and Research has oversight of the safety and effectiveness of these products.
FDA-Approved Fecal Microbiota Products
Safety Information
- Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to Monkeypox Virus
August 22, 2022 - Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation - Screening Donors for COVID-19 and Exposure to SARS-CoV-2 and Testing for SARS-CoV-2
April 9, 2020 - Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation -- Testing of Stool Donors for Enteropathogenic Escherichia coli and Shigatoxin-Producing Escherichia coli
April 6, 2020 - Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19
March 23, 2020 - Update to March 12, 2020 Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
March 13, 2020 - Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
March 12, 2020 - Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation - Screening and Testing of Stool Donors for Multi-drug Resistant Organisms
June 18, 2019 - Important Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms
June 13, 2019