TORONTO – The United States Food and Drug Administration has issued a warning letter to a company appearing to sell products containing human fecal matter without approval from the agency.
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. 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 letter also says these particular products raise “potential significant safety concerns,” due to insufficient screening. “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.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.
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.”