The United States Food and Drug Administration (FDA) has issued a warning letter to a company appearing to sell products containing human fecal matter without approval from the agency.
In March, the FDA wrote to Human Microbes, a company advertising itself as “the world’s largest, highest quality stool donor bank” for Fecal Microbiota Therapy (FMT) transplants, after reviewing its website a month prior.
According to Health Canada, FMT is the transfer of bacteria from the feces of a healthy person to the gut of a patient to re-establish a healthy microbiome, executed through enema, colonoscopy, or other means.
A spokesperson for Health Canada confirmed to CTVNews.ca that this type of therapy should only be used in the context of an authorized clinical trial, or to treat patients with recurrent Clostridium difficile (also known as C. difficile), a bacteria that causes diarrhea and intestinal conditions, like colon inflammation.
Per Human Microbes’ website, FMT yields “promising results in clinical trials” to treat other conditions, such as irritable bowel syndrome, Parkinson’s disease, multiple sclerosis and mental health disorders like depression and anxiety, among others.
Human Microbes appears to sell fecal microbiota for transplantation through capsules and enema to those in the United States, Canada and the rest of the world, and appears to have sought out high-quality stool donors, offering US$500 per donation.
In the FDA’s letter, the agency says that to “lawfully market” these biological products, a valid biologics licence application is needed. Since these products are considered new, an FDA-approved application must be in effect to introduce and deliver them. Additionally, an investigational new drug application must be in place for products to be distributed to people in clinical trials while in the development stage.
According to the FDA, Human Microbes does not have any of the required applications and consequently are “both unapproved new drugs and unlicensed biological products.”
The administration also notes that, per its guidance issued in November 2022, FMT treatment 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 enforcement discretion policy.
“Although your website recommends that patients ‘discuss their plans with their doctor,’ it offers your products directly to patients, including for self-administration,” the letter reads. “Therefore, there is no assurance that a licenced health care provider treating each of these patients is directing the screening and testing of the stool donor and stool for the patient, as described in the November 2022 guidance.”
The letter also says these particular products raise “potential significant safety concerns,” due to insufficient screening.
The FDA advised Human Microbes to review its website and materials to ensure it is compliant under the Federal Food, Drug, and Cosmetic and Public Health Service acts, asking for a response on what the company’s next steps will be to correct any violations or provide reasoning on why the products are not in violation.
Rebyota and Vowst are currently both listed as FDA-approved fecal microbiota products.
According to a blog post in response to the FDA’s letter, Human Microbes’ founder Michael Harrop said they intended to run the products as a clinical trial, “but all I could find were companies charging $1,500 to tell you whether or not it was possible.”
“I also contacted the FDA about getting approved for an IND (investigational new drug) application and never heard back. So I continued as is,” Harrop’s post reads. He agrees Human Microbes should be regulated, but as a “source of stool donors” rather than a drug developer.
“I’m searching for people healthy enough to be stool donors. Researchers, doctors, clinical trials, etc., can then purchase stool from our donors. I’m not sure what the exact requirements are, but it is widely stated that IND requirements are extremely onerous,” Harrop’s post reads.
Harrop told CTVNews.ca via email that a meeting with the FDA is scheduled for next month, “after which I plan to post a new blog about major changes, regardless of what the FDA decides. But the blog will also cover what happens with the FDA.”
What Health Canada says about FMT
Per its guidance published in 2015, Health Canada says FMT can be used in treatment of C. difficile that isn’t responsive to conventional therapies. Licenced health care practitioners can treat patients with this type of therapy without a clinical trial application if certain conditions are met, like if the feces used is obtained from a single donor known to either the patient or health care practitioner and if the donor has been screened for all relevant transmissible diseases.
Outside of these circumstances, the use of fecal therapy must be conducted under an authorized clinical trial.
A spokesperson for Health Canada says it considers fecal therapy to be a drug, since it meets the definition laid out in the Food and Drugs Act, which can be any substance used in the “diagnosis, treatment, mitigation or prevention of disease.”
“The active ingredient is the human microbiota contained in feces, rather than the feces itself. Researchers are just beginning to understand the important role that human microbiota (i.e. bacteria that colonize the skin, gut and other tissue surfaces) appear to play with respect to human health,” the emailed statement reads.
So, like all new drugs, Health Canada stressed the importance of conducting clinical trials to adequately answer this treatment’s safety and efficacy. As of June 2024, Health Canada says it has approved 68 clinical trials for fecal therapies.
While Health Canada didn’t comment specifically on Human Microbes, the agency said only authorized products can be advertised and sold in the country.
“Selling unauthorized health products or making false or misleading claims to prevent, treat or cure illnesses is illegal in Canada.”
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2024-06-23 18:09:26Z
CBMimAFodHRwczovL3d3dy5jdHZuZXdzLmNhL2hlYWx0aC90aGlzLXUtcy1jb21wYW55LWlzLXNlbGxpbmctcHJvZHVjdHMtd2l0aC1odW1hbi1mZWNhbC1tYXR0ZXItdG8tY2FuYWRpYW5zLXdoYXQtZG9lcy1oZWFsdGgtY2FuYWRhLXRoaW5rLWFib3V0LWl0LTEuNjkzNzkxMNIBAA
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