Understanding the FDA's Stance on FMT in 2023

June 6, 2023

In a groundbreaking move, the U.S. Food and Drug Administration (FDA) has given the green light to the first fecal microbiota product, Vowst, that can be taken orally. This significant development, announced on April 26, 2023, marks a new chapter in treating recurrent Clostridioides difficile infection (CDI), among many other conditions.

However, before becoming a publicly available treatment, the procedure has to pass through the gatekeeper of America’s healthcare innovations, the FDA. Their stance can significantly impact its accessibility, usage, and future development. 

In this article, we'll delve into the FDA's perspective on FMT in 2023, shedding light on the implications for patients, healthcare providers, and the future of medicine.

What is FMT?

Fecal Microbiota Transplantation (FMT) is a medical procedure making waves in the healthcare industry. It's a topic that might make some squeamish (we get it!), but the potential health benefits are too significant to ignore. 

FMT, in simple terms, involves the transfer of fecal matter from a healthy donor into the gastrointestinal tract of a patient. It's a procedure that has been around for centuries in some form or another, but it's only recently that it has gained traction in modern medicine. 

The Journey of FMT: From DIY Methods to FDA Approval

The journey of FMT has been a rollercoaster with many ups and downs. One such story is that of Lara Thompson, a researcher for HIV prevention, who was diagnosed with a Clostridium difficile (C. diff) infection in 2008. 

Despite being put on a drug treatment plan, her condition worsened. Desperate for a solution, Lara came across FMT as a potential treatment. Using her boyfriend as her donor, Lara underwent the procedure and experienced a remarkable recovery within two hours, and her condition never returned after three years.

FDA's Stance on FMT in 2023

Fast forward to 2023, and the FDA's stance on FMT has evolved to reflect the growing body of research supporting its efficacy and safety. The agency now recognizes FMT as a legitimate treatment for recurrent C. difficile infections when other treatments have failed (as illustrated by Lara’s incredible recovery.)

However, the FDA maintains that FMT should be used cautiously due to potential risks, including the transmission of infectious diseases through improperly screened feces.

In an effort to minimize these risks, the FDA has implemented a comprehensive screening process for FMT donors. This includes:

  • Testing for various infectious diseases
  • Assessing the donor's medical history
  • Evaluating lifestyle factors that could impact the donor's gut microbiota

The FDA has historically classified FMT as a biologic drug, subjecting it to stringent regulations akin to those for similar treatments. 

FMT Delivery Methods

The introduction of an orally administered product as an FMT treatment is a significant advancement in the field for several reasons.

First, it provides a non-invasive delivery method, which can be more comfortable and accessible for patients. This is particularly important for those who may be unable or unwilling to undergo more invasive procedures such as colonoscopy or enema.

Additionally, oral administration allows for outpatient treatment, potentially reducing healthcare costs and increasing patient convenience. 

However, as Luca, an expert from Injoy, points out, "Fecal microbiota transplantation (FMT) is available orally in some cases, but it may have some drawbacks compared to other delivery methods." 

These limitations include:

  • The need for multiple doses
  • Potential gastrointestinal side effects
  • Possible reduced efficacy due to degradation of fecal material
  • Lack of standardized protocols for capsule preparation
  • Regulatory challenges

Despite these challenges, the approval of an orally administered product is a significant step forward, providing a new avenue for FMT treatment.

Causes and Treatment of CDI

CDI is among the most common healthcare-associated infections in the United States, associated with 15,000 to 30,000 deaths annually. It occurs when the balance of microorganisms in the gut is disrupted, allowing the infectious bacteria to multiply and release toxins. 

This can cause symptoms such as:

  • diarrhea, 
  • abdominal pain, 
  • fever, 
  • and, in severe cases, organ failure and death. 

The FDA approval paves a new treatment option for individuals suffering from recurrent CDI, offering hope for those who have not responded to traditional treatments.

Additionally, FMT has been linked as an alternative treatment to:

It’s important to note that FMT is currently available mainly for treating c. Diff.,  as other conditions are subject to approval by a doctor or are only available through clinical trials.

If you’re looking for an in-depth list of resources ranging from articles, podcasts, and websites all on the topic of FMT, check out this article.

Future Implications

The FDA's approval is a significant step forward in the field of FMT – leading the way for further research and development in this area. The future may see the expansion of approved uses of FMT beyond C. difficile infections and further refinements in the donor screening process. 

This development also underscores the importance of ongoing research and clinical trials in advancing our understanding of FMT and its potential applications.

The "Designer Shit" Documentary

For those interested in learning more about the fascinating world of FMT, the "Designer Shit" documentary is a must-watch. 

This film delves into the potential of FMT to treat a range of conditions, from Crohn's disease to Parkinson's. It features interviews with leading researchers in the field, as well as first-hand accounts from patients who have undergone FMT. 

The documentary provides a comprehensive and engaging look at this promising medical breakthrough. You can learn more about the film by checking out its trailer.


In 2023, the FDA's stance on FMT has taken a significant step forward with the approval of the first orally administered fecal microbiota product. This development not only provides a new treatment option for recurrent CDI but also opens up new possibilities for using FMT in treating other conditions. As we continue to explore the potential of FMT, it's clear that this field holds great promise for the future of medicine.

Learn more about Luca and what Injoy offers by visiting their website.