Members of Apollo House, an upscale medical spa that opened earlier this year near Union Square, can pop in to take advantage of the hot tub and infrared saunas or to get aesthetic treatments such as Botox.
But many go for the latest wellness trend: injections of experimental drugs that are being promoted by social media influencers for wide-ranging benefits such as better skin, increased energy and faster recovery from injuries. They are often offered in combinations known as stacks and all fall under the vast category of compounds known as peptides.
Shervin Nassi, a 37-year-old partner at Apollo House, counts himself among the converts after starting on injections of the popular “Glow Stack,” a combination of the peptides BPC-157, TB-500 and GHK-Cu. For Apollo House customers, a “peptide stack membership” is listed on the website for $350 a month, though the company said pricing can vary.
“ I don’t hear the click in my knees anymore,” Nassi said. “Also, I felt like my hair got thicker and people were telling me I was looking better.”
For the uninitiated, peptides are short chains of amino acids that naturally occur in the human body, helping to regulate the metabolism and other bodily functions. Some have been synthesized into well-established medicines, with their efficacy and safety backed by clinical trials and approvals from the U.S. Food and Drug Administration. Insulin is a peptide as are the active ingredients in the commercial weight loss drugs Ozempic and Zepbound.
But in recent years, a vast gray market has sprung up around a host of other synthetic peptides that are being touted for purposes such as bodybuilding, anti-aging and tanning, even though they have yet to be approved by the FDA. BPC-157, for instance, has demonstrated the potential to heal muscles and tendons in animal studies, but has yet to be rigorously tested on humans.
U.S. Health and Human Services Secretary Robert F. Kennedy Jr. is now leading the charge to ease federal restrictions on the manufacture of some of these drugs, even as scientific research lags — arguing that the biggest risk to consumers is a lack of regulated suppliers. The FDA recently announced it will convene a federal advisory committee on the issue in July.
But some New Yorkers aren’t waiting for new evidence or regulations. Doctors around the city said they are fielding more and more questions about experimental peptides from patients, including some who are purchasing them independently and injecting them at home.
Peptide users trade sources online, including wholesalers in China and online companies that market peptides as research chemicals not meant for human consumption. The question of which labs to use to test these products for purity — and how to vet the legitimacy of the results — is also a common topic of discussion on peptide forums.
Those familiar with the peptide market say the do-it-yourself approach is common.
“People are sourcing peptides independently, often from overseas suppliers or unregulated online vendors, with no clinical oversight and no way to verify purity or dosing accuracy,” said Dr. Michael Werner, a urologist and medical director of Maze Health, a sexual and reproductive health practice with locations in Midtown and Westchester.
Werner said he takes a “cautious position” on unapproved peptides, acknowledging both the promise some of them hold and the lack of clinical data. But he said he can’t ignore the demand.
“If a patient is determined to use a compound, regardless of what we recommend, the question becomes whether we’re better off being involved or not,” Werner said.
Dr. Michael Ghalchi, a cardiologist and founder of Apollo House, argued he is providing a safer option by offering medical guidance on peptides, having staff inject people onsite and sourcing his peptides from U.S. compounding pharmacies that are authorized to produce custom drugs.
“It comes down to informed consent, helping people understand the risks and benefits,” Ghalchi said.
But even compounding pharmacies are in legal limbo when it comes to these peptides, experts say.
Are big changes coming for peptides?
Kennedy has said he’s a fan of experimental peptides and has accused the Biden administration of fueling the underground market by restricting them. “My hope is that they will get moved to a place where people will have access from ethical suppliers,” Kennedy told Joe Rogan in February.
The FDA recently announced it will convene an advisory committee in July to review the status of seven of the experimental peptides that were placed on a list of ingredients compounding pharmacies were barred from working with under the Biden administration because of “potential significant safety risks.”
One of the peptides that will be under review is BPC-157. In 2023, the FDA said it had the potential to cause an unwanted immune response and that the agency lacked sufficient data to know whether the drug would cause harm to humans.
But some compounding pharmacies in the United States already advertise the sale of BPC-157. “There are compounding pharmacies that make it available through different protocols,” Ghalchi said.
Dae Lee, an attorney at the firm Buchanan, Ingersoll & Rooney who consults with pharmacists on compliance issues, said compounding pharmacies could face legal sanctions for producing drugs with restricted peptides but said enforcement is at the discretion of both the FDA and state oversight bodies.
The New York State Education Department, which oversees compounding pharmacies, said it has not issued any guidance around peptides and did not answer specific questions about its approach to enforcement.
But Lee said many compounding pharmacies across the country have held off on producing drugs with the restricted peptides and are waiting in the wings for regulations to change.
Doctors who spoke to Gothamist had mixed opinions on the potential regulatory shift.
Dr. Danielle Qing, an assistant professor of internal medicine at Mount Sinai, worried that peptides that have not been FDA-approved could come away with a sheen of legitimacy.
“ There’s no good clinical data in human trials to show that they’re safe or that they’re efficacious,” she said.
Werner said he was less concerned about the particular peptides under discussion and more worried about opening up a back-channel to manufacture other drugs in the future that may have “far less favorable risk profiles.”