The US Food and Drug Administration (FDA) has issued warning letters to companies that appear to be selling products containing human waste without the FDA's approval.
In March, the FDA sent a letter to Human MicroBeads, which bills itself as “the world's largest and highest quality stool donor bank” for fecal microbiotherapy (FMT) transplants, after inspecting the company's website a month earlier.
According to Health Canada, FMT involves transferring bacteria from a healthy person's stool into a patient's intestine to re-establish a healthy microbiome, and is performed by enema, colonoscopy or other means.
A Health Canada spokesperson confirmed to CTVNews.ca that this type of treatment should only be used within the scope of approved clinical trials or to treat patients with recurrent disease of Clostridium difficile (also known as C. difficile), a bacterium that causes intestinal illnesses such as diarrhea and colitis.
According to the Human Microbes website, FMT has shown “promising results in clinical trials” in treating other conditions, including irritable bowel syndrome, Parkinson's disease, multiple sclerosis, and psychiatric disorders such as depression and anxiety.
Human Microbes appears to sell fecal microbes for transplant in capsules and enemas in the United States, Canada and other countries, and is seeking high-quality fecal donors, offering $500 per donation.
The FDA letter states that these biological products require a valid Biologics License Application in order to be “lawfully marketed.” Because these products are considered new products, they must have a valid FDA approval application in order to be introduced and distributed. Additionally, products in development require an Investigational New Drug Application in order to be distributed to people in clinical trials.
According to the FDA, Human Microbes never filed any required applications, and as a result, it is “both an unapproved new drug and an unlicensed biological product.”
The administration also noted that, according to guidance issued in November 2022, there is more limited data on FMT treatment for diseases other than C. difficile , and studies of the treatment for other uses are not included in the FDA's enforcement discretion policy.
“Although your website encourages patients to 'discuss plans with their physician,' you provide your products directly to patients, including for self-administration,” the letter reads. “Therefore, we have no assurance that licensed health care providers treating these patients are ordering screening and testing of patients' stool donors and stool samples, as described in your November 2022 guidance.”
The letter also said these particular products pose “potentially significant safety concerns” due to insufficient testing.
The FDA advised Human Microbes to verify that its website and materials comply with the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and requested responses including requests for future steps to correct the violations and explanations of why the products are not in violation.
Rebyota and Vowst are now both listed as FDA-approved fecal microbiome products.
In a blog post responding to the FDA letter, Human Microbes founder Michael Harrop said he intended to run clinical trials on his product but “could only find companies charging me $1,500 to tell me if that was possible.”
“I also contacted the FDA to get approval for my IND (Investigational New Drug) application but never heard back, so I just carried on,” Harrop's post reads. He agrees that Human Microbes should be regulated, but as a “source of stool donors,” not as a drug developer.
“I am looking for people healthy enough to be stool donors. Researchers, doctors, clinical trials etc. can purchase stool from our donors. I don't know what the exact requirements are, but it is widely said that the IND requirements are very strict,” Harrop's post read.
Harrop told CTVNews.ca in an email that a meeting with the FDA is scheduled for next month, and “after that we will post a new blog about any major changes, regardless of the FDA's decision, but the blog will also address what's going to happen at the FDA.”
What Health Canada says about FMT
Health Canada said in guidance published in 2015 that FMT can be used to treat C. difficile that doesn't respond to conventional treatments. Licensed health care practitioners can treat patients with this type of therapy without a clinical trial application if certain conditions are met, including that the stool used comes from a single donor known to either the patient or the health care practitioner, and that the donor has been tested for all relevant communicable diseases.
Outside these circumstances, the use of bowel therapy must be conducted in the context of an approved clinical trial.
A Health Canada spokesperson said the agency considers bowel therapy to be a drug because it meets the definition of any substance used in the “diagnosis, treatment, mitigation or prevention of disease” in the Food and Drugs Act.
“The active ingredient is not the feces itself, but the human microbiota it contains. Researchers are only beginning to understand the important role that the human microbiota – i.e. the bacteria that colonize our skin, gut, and other tissue surfaces – plays in human health,” the emailed statement read.
Health Canada therefore stressed the importance of conducting clinical trials to adequately answer questions about the safety and efficacy of this treatment, as with all new medicines. As of June 2024, Health Canada said it had approved 68 clinical trials for bowel therapy.
Health Canada did not comment specifically on Human Microbes, but said only approved products can be promoted and sold in the country.
“In Canada, it is illegal to sell unlicensed health products or make false or misleading claims about preventing, treating or curing disease.”
