1. United States
2. Ariz.
3. Letter

The current classification of fecal microbiota transplantation (FMT) as a drug is causing public harm. I’m asking you to use congressional oversight to ensure the FDA updates its regulatory approach to FMT. It needs to align with the frameworks used for other biological materials. FMT is not a drug; it is a living microbial community and these communities can be used safely to repair many health conditions including ulcerative colitis, irritable bowel syndrome, hepatic encephalopathy, and several microbiome-driven disorders. Safety depends on donor quality and screening, not chemical manufacturing processes. Today, the FDA treats FMT as an unapproved drug and requires drug-manufacturing standards that do not fit the biology of this therapy. High-quality, well-screened donors are blocked, while unsafe or informal routes remain available. Clinicians can’t use safe sources even when they want to supervise care, and clinical development is held back because drug-manufacturing rules are incompatible with donor-based therapies. Congress has stepped in before when a biological material didn’t fit drug rules, creating tailored frameworks for tissues, blood, and human cellular products. FMT fits this same pattern. The FDA needs an FMT-specific pathway that focuses on donor standards, clinician oversight, and appropriate safety tracking, without imposing drug requirements that don’t improve outcomes. I’m asking you to direct the FDA to establish a dedicated regulatory category for FMT that aligns oversight with biology. This would center regulation on donor quality, medical supervision, and outcome tracking, while removing drug-manufacturing requirements that do not fit. A straightforward update in classification can reduce harm, improve safety, and open a path for appropriate clinical use. Thank you for your attention to this needed modernization.