Neill Stollman has been called the Tupac of poop transplants. The Oakland-based, board-certified gastroenterologist didn’t invent the treatment. But he did bring it to the west coast. His first patient was a woman in her 80s with a horrible case of Clostridium difficile, a gut infection that can strike patients after a course of antibiotics clears out their existing bacterial community. It’s also one of the deadliest antibiotic-resistant threats in the US, costing the healthcare system an estimated $5 billion each year. Drugs had stopped working for the woman, and without some kind of treatment, she was going to die.

So Stollman took a stool sample provided by the patient’s nurse’s husband, made a poop shake, and performed California’s first fecal microbiota transplant—a so-called FMT. The new bacteria repopulated her gut and she made a full recovery. Since then, Stollman has successfully performed the procedure hundreds of times, though he no longer has to ask his staff to break out the blender. Now he gets a few frozen poopsicles a week, which he can thaw out on a patient-by-patient basis. “I used to be the only guy doing this for 500 miles,” he says. “I had to beg my staff to do it.” Today, 98 percent of the US population lives within two hours of a fecal transplant provider.

98 percent of Americans live within 2 hours of a fecal transplant provider Pratik Panchal

Since the nation’s first stool bank opened in 2012, it's sent out nearly 30,000 frozen FMT doses. But nobody, least of all the US Food and Drug Administration, sees stool banks as a long-term solution. Most doctors expect the FDA will shut them down the moment a less-messy treatment gains approval—there are a handful of contenders currently in the pipeline, including microbiome-based drugs from Seres, Rebiotix, and Vedanta Biosciences. For now though, no poop pills have crossed the finish line, and stool banks remain unregulated. Fecal transplants are caught in a legal limbo even as they grow in popularity.

Which is why some scientists and legal experts are suggesting that poop be treated not like a drug, but like a tissue—requiring stool banks to report to a registry that tracks patient outcomes and safety data. Writing today in Science, a group of doctors, researchers, and lawyers from the University of Maryland recommend a major regulatory overhaul that will keep access to the life-saving treatment available to patients, while hitting the pause button on anything not backed by serious science.

Over the past four years, the FDA has struggled with how to regulate FMTs, changing and unchanging its mind several times. In May 2013, the agency declared it would treat the transplants like drugs, meaning the only way patients could get them was by enrolling in a clinical trial. Two months later, after much patient and physician outcry, the agency made an exception for doctors using transplants to treat recurrent C diff. But they were still prohibited from using it to treat anything else. In 2016, that stance got even more restrictive, as the agency proposed an effective ban on doctors buying samples from stool banks for anything but approved clinical trials. That draft guidance is still awaiting finalization.