The U.S. Food and Drug Administration (FDA) has issued a warning letter to a company that appears to be selling products containing human feces without the agency's approval.

In March, the FDA wrote to Human Microbes, a company that markets itself as "the largest and highest quality stool donation bank in the world" for fecal microbiota transplants (FMT), after reviewing its website the previous month.

According to Health Canada, FMT is the transfer of bacteria from the stool of a healthy person to the intestines of a patient to restore a healthy microbiome, and it is performed through an enema, colonoscopy, or other means.

A spokesperson for Health Canada confirmed to CTVNews.ca that this type of treatment should only be used in the context of an approved clinical trial, or to treat patients suffering from recurrent Clostridium difficile (also known as C. difficile), a bacterium that causes diarrhea and intestinal conditions such as colitis.

According to the Human Microbes website, FMT shows "promising results in clinical trials" for treating other conditions such as irritable bowel syndrome, Parkinson's disease, multiple sclerosis, and mental health disorders like depression and anxiety, among others.

The human microbes company appears to sell fecal microorganisms for cultivation via capsules and enemas to those in the U.S., Canada, and around the world, and it seems to have sought high-quality stool donors, offering $500 for each donation.

In the FDA letter, the agency states that to "legally market" these biological products, a valid biologics license application must be submitted. Since these products are considered new, there must be a currently approved FDA application in effect to provide and deliver them. Additionally, there should be an investigational new drug application to distribute the products to individuals in clinical trials during the development phase.

According to the FDA, Human Microbes does not have any of the required applications, thus they are "unapproved new drugs and unlicensed biological products."

The agency also notes that, according to its guidelines issued in November 2022, FMT for other conditions outside of C. difficile has more limited data, and the study of this treatment for other uses is not included in the FDA's discretionary enforcement policy.

The letter states: "While your website advises patients to discuss their plans with their healthcare provider, it directly offers your products to patients, including self-management." "Therefore, there is no assurance that the licensed healthcare provider treating any of these patients is the one directing the screening and testing of the stool donor and the patient's stool, as outlined in the November 2022 guidelines."

The letter also states that these specific products raise "significant potential safety concerns" due to inadequate screening.

The FDA has advised Human Microbes to review its website and materials to ensure compliance with federal laws regarding food, drugs, cosmetics, and public health, and requested a response regarding the next steps the company will take to correct any violations or provide reasons why the products do not violate.

Both Rebyota and Vowst are currently listed as FDA-approved fecal microbiota products.

In a blog post responding to the FDA letter, the founder of Human Microbes, Michael Harop, said they intend to operate the products as a clinical trial, "but all I could find are companies charging $1,500 to tell you whether that is possible or not."

Harop added, "I also contacted the FDA about obtaining approval for an IND (Investigational New Drug) application and received absolutely no response. "So I just carried on as is," he agrees that human microbes need to be regulated, but as a "source of stool donors" and not as a drug developer.

"I am looking for healthy individuals enough to be stool donors. Researchers, doctors, clinical trials, etc. can purchase stool from our donors. "I am not sure of the exact requirements, but IND requirements are widely reported to be extremely burdensome," according to Harop’s post.

Harop told CTVNews.ca via email that a meeting with the FDA is scheduled for next month, "and after that, he plans to publish a new blog about the key changes, regardless of what the FDA decides. But the blog will also cover what is happening with the FDA.

What does Health Canada say about FMT

According to its guidelines published in 2015, Health Canada states that FMT can be used to treat C. difficile that does not respond to conventional therapies. Licensed healthcare practitioners may treat patients with this type of therapy without implementing a clinical trial if certain conditions are met, for example, if the stool used is obtained from a known single donor either to the patient or the healthcare practitioner and if the donor is screened for all relevant infectious diseases.

Outside of these circumstances, fecal treatment must be used under an approved clinical trial.

A spokesperson for Health Canada states that fecal treatment is considered a drug, as it meets the definition set out in the Food and Drugs Act, which can be any substance used in "the diagnosis, treatment, or prevention of disease."

"The active ingredient is the human microorganisms present in the stool, not the stool itself. Researchers are just beginning to understand the important role that human microorganisms (i.e., the bacteria that inhabit the skin, gut, and other tissue surfaces) seem to play concerning human health.

So, like all new drugs, Health Canada emphasized the importance of conducting clinical trials to properly answer the safety and efficacy of this treatment. As of June 2024, Health Canada states it has approved 68 clinical trials for fecal treatments.

While Health Canada has not specifically commented on Human Microbes, the agency stated that only licensed products may be advertised and sold in the country.

"Selling unauthorized health products or making false or misleading claims for disease prevention or treatment is illegal in Canada."