U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Vaccines, Blood & Biologics
  3. Fecal Microbiota Products
  1. Vaccines, Blood & Biologics

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.



Back to Top