By Alex Arsenych | CTV Network
TORONTO – 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 California 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.
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Source:: The Mercury News – Entertainment
