FDA to Discuss Peptide Reclassification Amid Industry Anticipation and Safety Concerns

Has anyone tried to sell you peptides yet? If not, they probably will soon. Once a niche interest among bodybuilders and biohackers, peptides are an increasingly popular class of substance hyped by both fringe influencers and the current US secretary of Health and Human Services.

Earlier this year, Robert F. Kennedy Jr. told the podcaster Joe Rogan that the government intended to loosen restrictions on peptide production. This week, it could finally happen: On July 23 and 24, the Food and Drug Administration will discuss whether to reclassify a group of peptides so that pharmacies can legally make custom mixes, a process known as compounding. The move would reverse a decision made in 2023 by the Biden administration, which barred certain peptides from being compounded.

Although career scientists at the agency have recommended against it, many industry insiders tell WIRED they believe the FDA will approve reclassification anyway, since the committee put together to do the assessment includes peptide boosters. Some players in the telehealth world are already operating under the assumption that the floodgates will soon open. “We’re getting everything ready to go,” says Myra Ahmad, the chief executive of the telehealth platform Mochi Health, which originally focused on GLP-1 medications. “We have pharmacies that have done all their safety testing stuff; they’re putting pricing together.”

Some of the largest telehealth companies have looked forward to this moment for over a year. Virtual health care juggernaut Hims & Hers Health purchased a peptide manufacturing facility in February 2025 and is developing clinical protocols for peptides, according to its chief medical officer, Anant Vinjamoori, who is slated to testify at the FDA hearing. Joshua Fritzler, president of the compounding pharmacy Olympia Pharmaceuticals, says the company has been preparing in advance of the anticipated changes, “spending a lot of money to create these formulas” to be ready if the FDA gives the green light.

“There’s an understanding in the industry that something big is happening,” he says.

The GLP-1 boom warmed people up to the idea of injecting medications at home and proved to be a cash cow for pharmacies and virtual clinics. Now, though, many of these companies are eager to expand their horizons. Cole Thomas, the director of sales and operations at the pharmacy marketing and technology platform RxConnexion, says that some of the company’s compounding pharmacy clients are testing peptides that are likely to be popular. One such variety, BPC-157, is touted as a healing compound and is one-half of the combination known as the “Wolverine stack.” (BPC stands for “body protection compound.”)

Cameron Bravo, a research scientist at the biotech firm Sapho Bio, says his company has been approached about testing a variety of peptides already, too. (Mochi Health is a client.) Sapho Bio runs tests to “validate” formulas that clients bring, ensuring the mixtures are uncontaminated and properly sealed. So far, it has tested BPC-157 as well as more obscure offerings like MOTS-c, which is hyped as “exercise in a vial” by evangelists. Some of the pharmacies the company works with are testing multiple products, at significant cost. “They're probably investing something like $100,000 into these before they're even fully out yet,” he says.

Even if this week’s meeting goes exactly how peptide boosters want it to go, with the committee approving all of the substances up for discussion, that won’t lead to an immediate green light for sellers. The next step involves a review period, during which the FDA will propose rules and the public will be able to comment. “It’s a long-winded process,” says Gerard Olson, who was recently the director of research at LegitScript, a company that provides certifications for telehealth providers and pharmacies.

Hims plans to wait and see. “We don't want to be necessarily first to market. We want to be best in market,” says Vinjamoori, the chief medical officer.

But other compounders and clinics are moving ahead with prescribing these medications as injectables.

Amanecia Health, a concierge service that sees patients in person at its Texas and Virginia clinics in addition to operating a telehealth practice, has started prescribing popular options like BPC-157. “There's been an uptick in interest because it's been all over Instagram and the media,” says Amanceia’s founder Ann Czarnik, who also works as an emergency medicine physician. Even though Czarnik readily acknowledges that these substances do not have the same kind of safety and efficacy data that traditional medications do, her practice has begun tentatively prescribing them to a small group of patients; she stresses that this “tiny percentage” of her patient base is aware that they are not FDA-approved medications. “I can’t advertise that I’m prescribing them yet,” she says.

Scott Brunner, the head of the Alliance for Pharmacy Compounding, has been warning member pharmacies to comply with the law and not go rogue and roll out peptides early. “Many of them are being hammered by prescribers and patients to do this,” he says. To make the temptation even more intense, these compounders know that the people they turn away have easy access to a gray-market supply.

Right now, all of the peptides up for discussion in the July FDA meeting, as well as many others, are remarkably easy to get your hands on. They’re available for purchase from online sellers that place disclaimers on their products, noting that they are “research-grade only” and not for human consumption.

“We are not selling. It is not legal for us to do so,” says Olympia’s Fritzler. “This gray market, which is insane—obviously we are not participating in it.”

“Everyone and their mom wants to start a peptide company right now,” says Thomas Millman, who runs OnTop Labs, a Florida-based research-use peptide operation. OnTop Labs sells products like Melanotan II, known as the “Barbie peptide” and the “tan jab” for the way it stimulates melatonin production and changes skin pigmentation. It’s also slated for an FDA discussion on reclassification, but not until 2027. The Skin Cancer Foundation recently issued a warning about Melanotan II, citing case reports about increased melanoma risk.

Nevertheless, Millman promotes his products on social media, primarily TikTok. The glut of companies offering research-grade peptides has made it more difficult to stand out, he says. “There’s just so much more competition.”