San Francisco, Calif. — Tuxedo-clad party hosts moved through the crowd proffering trays of peptide creams and peptide-infused dissolvable strips as if they were hors d’oeuvres.
Jen Scott accepted a plastic cup and scooped up a pea-sized dab containing GHK-Cu, a copper tripeptide frequently used in topical beauty products for its reported skin-firming properties.
“I love it. I can’t get enough,” Scott said, massaging the white cream into her neck.
Scott, 59, was also interested in trying the sublingual strips containing BPC-157 and TB-500, two peptides often recommended by biohackers and wellness influencers for tissue repair and healing.
Neither BPC-157, TB-500 nor injectable GHK-Cu is approved by the U.S. Food and Drug Administration for human use in any form, though topical GHK-Cu is a legal cosmetic ingredient. The sublingual strips’ foil packet read “Warning: For research use only” in tiny print on the back, an indication the contents are meant for lab study only and haven’t been vetted for human consumption.
Peptide parties — social gatherings where attendees mingle, chat about peptides and perhaps sample a few — have cropped up lately in San Francisco and other cities with large concentrations of the wellness-curious.
But last week’s event aboard the S.S. Jeremiah O’Brien — a World War II Liberty ship and event space on San Francisco’s Embarcadero — took place during “probably the most historic week in the history of consumer peptides,” according to party co-host and peptide entrepreneur Jeff Tang.
On Oct. 28, the U.S. Department of Health and Human Services issued an enforcement discretion policy saying that until a final FDA rule is ready, the government will decline to take any action against pharmacies compounding six peptides — BPC-157, TB-500, KPV, epitalon, Semax and MOTS-c — providing manufacturing and reporting guidelines are met.
Given “significant interest in the use of these peptides in compounding,” the policy document states, the “Secretary has determined that the policy advances patient choice and freedom while appropriately protecting patient safety.”
Advocates for the policy say it creates a safer alternative to the unregulated gray market currently supplying many peptides. Several researchers and regulatory experts expressed frustration with it, saying that it vastly expands access to a class of consumer products for which there is little evidence on their safety and efficacy in humans.
“What it does is allow companies to profit without proving that their products work,” said Patricia Zettler, a professor at the Moritz College of Law at the Ohio State University and former attorney for the FDA and the health agency.
In many ways, peptides are similar to previous generations of wellness supplements, said Dr. Pieter Cohen, an associate professor of medicine at Harvard Medical School.
“What’s different right now in the current era, dramatically different, is that we have a government which is helping these types of fads be promoted,” Cohen said. “The FDA’s role has completely reversed to be one of facilitating this type of magical thinking and promotion of the untested and unproven.”
In biology, a peptide is a short chain of amino acids that acts as a chemical messenger. Several that the human body naturally produces have been turned into effective medications, including insulin, human growth hormone and glucagon-like peptide-1, or GLP-1.
Recent years have brought a surge of interest in the potential therapeutic benefits of other peptides. Though not FDA-approved as drugs, a host of injectable peptides — including the six named in the Health and Human Services policy — are widely available online, often produced in overseas pharmacies and sold in vials marked “for research use only.”
A self-described “big fan” and user of peptides, Health Secretary Robert F. Kennedy Jr. pledged to end the government’s “aggressive suppression” of them even before his nomination to the office.
In July, an FDA committee went against advice from agency scientists and voted to recommend that compounding pharmacies be allowed to produce those six peptides.
Health and Human Services’ enforcement policy fast-tracks the peptides’ availability, permitting their manufacture before the FDA acts on a final rule.
To date, the vast majority of research on the six peptides now permitted for compounding has been in animals or individual cells and tissues. The amount and quality of evidence varies among the six, but all have shown potential in the lab to influence processes related to repair and recovery at the cellular or molecular level.
Interest in their use as wellness supplements has built through word of mouth, fueled by positive reports from podcasters, influencers and alternative medicine providers impressed with the peptides’ effects on themselves or clients.
One study, which has not yet been peer reviewed, found a 33-fold increase from 2020 to 2026 in patients of one U.S. healthcare system reporting use of BPC-157, which has been associated with cell regeneration in several animal studies and is often recommended for injury recovery.
Although there is no data on how different synthetic peptides interact with one another, they’re frequently taken together in custom combinations, or “stacks.” The HHS policy prohibits pharmacies from compounding peptide combinations.
BPC-157 and TB-500, a synthetic peptide fragment that in animal studies has been associated with wound healing and tissue repair, are a particularly popular pairing known as the “Wolverine stack.” (It’s named for the Marvel comic character with superhuman injury recovery.)
Attendees at the shipboard peptide party argued that in the absence of clinical trials, anecdotal data — typically near the bottom of the traditional evidence hierarchy — deserves more weight.
Hanieh Sigari, founder and chief executive of the telehealth company EllieMD, said she has heard from “millions of patients” reporting positive experiences with peptides.
“You can’t ignore the anecdotal evidence and just keep saying that we don’t have enough research to back it,” she said during a panel discussion at the event.
Earlier this year Greg Dalli co-founded the company Afterglow Science, which manufactures strips with peptides and other supplements that dissolve in the mouth.
The company’s Wolverine Blend strips sell for $200 for a box of 30 or $60 for a pouch of seven. The strips, which were distributed as free samples at the party, contain 0.5 mg each of BPC-157 and TB-500.
Peptides are typically administered through injections or nasal sprays as most break down in the human digestive tract before reaching the bloodstream.
Enzymes and digestive acids destroy TB-500 before it can leave the intestine. While Croatian researchers have found preliminary evidence that BPC-157 survives in the gut, there have been no studies on whether it has any therapeutic effect on other human systems when taken orally.
There has been no published research on whether BPC-157 or TB-500 can be effectively taken sublingually, or under the tongue, as partygoers were encouraged to do with Afterglow’s strips.
“The real answer is, we don’t know,” Dalli said when asked by a moderator if oral peptides work.
The industry needs more research, Dalli said. Afterglow has earmarked 10% of online orders since early September to fund peptide research, according to its website, generating $829 as of Nov. 10.
In the meantime, he said, “you can’t ignore the anecdotal. We’ve given these peptides to hundreds of our friends and family, and it’s pretty flattering the percent of people that notice a difference, that believe this works … You have all these people seeing a result. It just seems so unlikely that that’s all placebo effect.”
Guests were required to sign a waiver acknowledging the possibility of risk in any product they tried at the party. The document did not state that the peptides they’d be offered for oral consumption were still officially designated for lab use only.
“Products labeled ‘for research use only’ should not be provided to people to treat or prevent health conditions,” Cohen said. “Providing these chemicals and encouraging people to consume them is completely wrong.”
Several researchers said they remain concerned about peptides’ widespread adoption before any safety or efficacy testing.
“If we were thinking about harm reduction, we wouldn’t be thinking only about current users,” said Zettler. “We’d also be thinking about what this does to the market, and it’s likely to open up the market and expose far more people to unproven products.”
The fact that the enforcement discretion policy came directly from Health and Human Services and not the FDA was highly unusual, Zettler said, “and I would take that as a signal that FDA’s scientific experts continue to have significant concerns about allowing the compounding of these particular products.”
On board the Jeremiah O’Brien, several partygoers declined the peptide samples, with one confiding that it seemed “a bit dodgy.”
Others pulled open packets, smeared on cream and networked with others interested in getting in early on the city’s next big thing.
“We’re back in the ‘70s again — everybody’s experimenting,” one bemused partygoer said.
The post For peptide enthusiasts, a new HHS policy means party time appeared first on Los Angeles Times.
