By Alex Arsenych | CTV Network
TORONTO – The U.S. Food and Drug Administration (FDA) has sent a warning letter to an organization that appears to be selling products containing human feces without obtaining approval from the agency.
In March, the FDA wrote to Human Microbes, a California-based company that promotes itself as “the world’s largest, highest-quality stool donor bank” for fecal microbiota therapy (FMT) transplants, after reviewing the corporate’s website a month earlier.
According to Health Canada, FMT is the transfer of bacteria from a healthy person's stool right into a patient's gut to revive a healthy microbiome, through an enema, colonoscopy or other means.
A Health Canada spokesperson confirmed CTVNews.ca that this kind of therapy should only be used as a part of an approved clinical trial or to treat patients with recurrent Clostridium difficile (also generally known as C. difficile), a bacterium that causes diarrhea and intestinal disorders equivalent to colitis.
According to the Human Microbes website, FMT shows “promising results in clinical trials” in treating other conditions, including irritable bowel syndrome, Parkinson’s disease, multiple sclerosis, and mental disorders equivalent to depression and anxiety.
Human Microbes appears to be selling stool microbiota for transplantation via capsules and enemas within the US, Canada and the remainder of the world. The company is outwardly in search of high-quality stool donors and is offering $500 per donation.
The FDA's letter states that a legitimate Biologics License application is required for “lawful marketing” of those biologic products. Because these products are considered recent, an FDA-approved application is required to introduce and provide them. In addition, an Investigational New Drug application is required to permit the products to be distributed to people in clinical trials through the development phase.
According to the FDA, Human Microbes doesn’t have any of the required uses and is subsequently “both an unapproved new drug and an unlicensed biological product.”
The agency also notes that, in line with its November 2022 guidance, there are limited data on FMT treatment for diseases apart from C. difficile, and investigating this treatment for other uses is outside FDA's enforcement discretion.
“Although your website advises patients to 'discuss their plans with their physician,' it offers your products directly to patients, including for self-administration,” the letter states. “Therefore, there is no guarantee that a licensed healthcare provider treating each of these patients will direct the screening and examination of the stool donor and the patient's stool as described in the November 2022 guidance.”
The letter also states that these particular products pose “potentially significant safety concerns” attributable to inadequate controls.
The FDA has directed Human Microbes to review its website and materials to make sure they comply with the Federal Food, Drug, and Cosmetic and Public Health Service Acts and has requested a response about what next steps the corporate will take to correct any violations or provide a rationale why the products don’t violate.
Rebyota and Vowst are each currently listed as FDA-approved products to combat fecal microbiota.
In a blog post responding to the FDA letter, Michael Harrop, founding father of Human Microbes, said that they had planned to run the products in a clinical trial, “but all I could find was companies that would charge me $1,500 to tell me whether that was possible or not.”
“I also reached out to the FDA to get approval for an IND (Investigational New Drug) application and never received a response. So I continued as before,” Harrop's post reads. He agrees that Human Microbes needs to be regulated, but as a “source of stool donors” reasonably than as a drug developer.
“I am looking for people who are healthy enough to be stool donors. Researchers, doctors, clinical trials, etc. can then purchase stool from our donors. I am not sure what the exact requirements are, but it is generally said that the IND requirements are extremely onerous,” Harrop's post reads.
According to a Health Canada guideline published in 2015, FMT may be used to treat C. difficile that has failed conventional therapies. Licensed health care professionals can treat patients with this manner of therapy without the necessity to submit a clinical trial application if certain conditions are met, equivalent to that the stool used comes from a single donor known to the patient or health care skilled and that the donor has been tested for all relevant communicable diseases.
Outside of those circumstances, using stool therapy should be a part of an approved clinical trial.
A spokesperson for Canada's Ministry of Health said that stool therapy is taken into account a drug since it meets the definition of the Canadian Food and Drug Act, which states that any substance may be used to “diagnose, treat, mitigate or prevent disease.”
“The active ingredient is the human microbiota contained in stool, not the stool itself. Researchers are only beginning to understand the important role that the human microbiota (bacteria that colonize the skin, gut and other tissue surfaces) appears to play in human health,” the emailed statement said.
As with all recent drugs, Health Canada stressed the importance of conducting clinical trials to adequately assess the security and efficacy of this treatment. As of June 2024, Health Canada says it has approved 68 clinical trials for stool therapies.
While Health Canada didn’t comment specifically on human microbes, it stated that only approved products could also be advertised and sold within the country.
“It is illegal in Canada to sell unapproved health products or make false or misleading claims to prevent, treat or cure disease.”
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