Creating a Safe, Supervised Pathway for FMT

The NIH estimates that about 26 million Americans have an autoimmune disease, and growing evidence shows that microbiome disruption plays a significant role in these conditions as well as in other chronic inflammatory disorders. Because the microbiome plays a central role in immune stability, disruptions in microbial health contribute directly to long-term disability. These conditions keep many Americans from participating in our society and our economy. Chronic illness imposes heavy costs on families, on health-care systems, and on the country’s overall capacity. One intervention shows meaningful potential to restore daily functioning, yet it remains unavailable to most people who could benefit. People with chronic conditions often seek fecal microbiota transplantation (FMT) when conventional options do not resolve their symptoms. In real-world use, some individuals experience meaningful recovery, including restored digestion, improved stability, and a return to daily routines. Others experience complications and, rarely, severe outcomes. We learn almost nothing from these outcomes because nearly all real-world FMT use in the United States takes place outside supervised medical care. DIY-FMT is widespread, with evidence that tens of thousands of people do it. These outcomes scale to national cost. Preventable injuries occur without standardized screening and oversight. Valuable real-world information is lost because it is never recorded. National resilience and economic strength decline when chronic illness remains unnecessarily entrenched. Congress can address this structural problem by directing the FDA to establish a supervised clinical pathway for FMT. That pathway should rely on donor screening, medical oversight, and basic outcome tracking. A modernized approach would reduce harm, support recovery, and generate real-world data that strengthens public health. This update would improve individual well-being and support the country’s overall capacity. A supervised pathway would serve both patients and the country.