FDA Cracks Down on the Gray Market for Human Poop

There’s a long history of breakthrough medical discoveries taking place around substances that most of us would consider, well, disgusting. No one much likes cleaning up mold, and yet mold played a huge role in the discovery of penicillin, which went on to save countless lives. More recently, a process known as fecal microbiota transplantation (or FMT) has gained in popularity.

Last year, the FDA approved a drug called Vowst, which uses poop to bolster the effectiveness and resilience of the human gut. It was the second time that the FDA had approved a drug of this type, but there’s also a grey market out there for human waste that might have healing properties. And, in a recent article for Slate, Luke Winkie explored one such community — which recently found itself on the receiving end of a harsh letter from the FDA.

The article manages the challenging task of being comprehensive without being too explicit. (That said, the phrase “fecal slurry” does show up once, which falls into the category of “things I cannot unread.”) Its focus is on a website called HumanMicrobes and its proprietor, Michael Harrop. Winkie describes Harrop as “something like an international middleman for poop,” matching feces from healthy people with buyers who are looking to have their ailments treated via unsanctioned methods.

This can sound both dubious and risky; as Winkie points out, people have died after fecal transplants from more regulated sources. On the other hand, patients of Harrop’s cited in the article did undergo recovery once they’d begun FMT.

The FDA is a bit more, shall we say, wary of Harrop’s operation. “Please be advised that to lawfully market a drug that is also a biological product, a valid biologics license application (BLA) must be in effect,” the agency wrote to him earlier this year. The letter went on to cite a number of areas where HumanMicrobes violates FDA policies, noting that “[y]our products also raise potential significant safety concerns due to inadequate donor screening.”

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That leaves the future of HumanMicrobes in doubt. “From what I understand, I have to change the whole website to say we’re not selling stool with the purpose of FMT,” Harrop told Slate. “That would be pretty drastic.” FMT doesn’t seem to be going anywhere — but it’s less clear if the list of ailments it’s used to remedy will be growing any time soon.