Thanks to legal loopholes and a patchwork of compelling research, businesses like Nushama in New York City are writing the rules as they go.
The décor of the Nushama Psychedelic Wellness Clinic was designed to look like bliss. “It doesn’t feel like a hospital or a clinic, but more like a journey,” said Jay Godfrey, the former fashion designer who co-founded the space with Richard Meloff, a lawyer turned cannabis entrepreneur.
The “journey,” in this instance, is brought on by ketamine, administered intravenously, as a treatment for mental health disorders, albeit one that has not yet been approved by the Food and Drug Administration.
“I thought, what does bliss look like?” Mr. Godfrey said. At Nushama, which occupies the entire 21st floor of a building in midtown Manhattan, it looks like 3,000 silk pastel flowers hanging from the ceiling, and a flat screen TV in the waiting room playing a “landscape of wonder” N.F.T. featuring lily pads and garlands of leaves that are, upon closer inspection, tiny nymphs — with wallpaper to match.
Mr. Godfrey closed his fashion business and founded Nushama in 2020. He had become disenchanted with the fashion world, he said, and had been using psychedelics for his own mental health for many years after being inspired by Michael Pollan’s best-selling book “How to Change Your Mind.” The light-bulb moment — Mr. Godfrey called it “an openhearted experience” — came at the beginning of the pandemic when he realized, “I have the ability to bring these medicines to people.”
It may be a calling, but Mr. Godfrey’s career pivot from fashion to wellness came as there was less of a need for the clothes he designed, and there was a ballooning interest in psychedelics as alternative treatments for mental health. Investors are banking on various psychedelic start-ups, including delivery services and luxury travel offerings. Nushama is just one example of what many see as the next frontier in health, which, thanks to legal loopholes and a patchwork of compelling research, is able to operate with limited oversight.
The F.D.A. doesn’t authorize ketamine for mental health treatment, though it allows the drug to be used as a sedative, making it possible to get a prescription in New York. It has authorized a version of ketamine, called esketamine, which is administered as a nasal spray, to be used for mental health, but only for treatment-resistant cases of depression — and while esketamine contains a molecular component of ketamine, the F.D.A. says these drugs are not the same.
In other words, ketamine treatment at Nushama is an “off-label” use of the drug, and representatives from the F.D.A., Federal Trade Commission and the United States Drug Enforcement Administration said they do not regulate off-label drug use, and therefore cannot comment on clinics like Nushama.
“There’s nothing suspicious” about off-label prescription use in general, said Mason Marks, a senior fellow at Harvard Law School specializing in the regulations around psychedelics, but ketamine providers need to be careful about over-promising the drug’s benefits, particularly when there’s limited evidence of its efficacy. According to Dr. Dan Iosifescu, a psychiatrist at N.Y.U. Langone, ketamine is also potentially addictive, heightening the risk of using the drug, even in a therapeutic setting.