Demand for restricted peptides has fueled an online gray market for injections promising youth, beauty and strength, and American businesses are racing — and taking risks — to get in on the craze. These drugs, which advocate a do-it-yourself approach to health and longevity, are largely unapproved by the Food and Drug Administration, meaning they cannot be marketed or sold for human consumption in the United States. But with the support of Health Secretary Robert F. Kennedy Jr., several popular peptides will soon be up for reclassification, paving the way for a multibillion-dollar wellness gold rush.
Telehealth companies are already building infrastructure for a future where compounding pharmacies can safely provide experimental peptides. In February 2025, Hims and Hers acquired a peptide compounding facility in Menlo Park, California. Just this April, digital-health company Noom acquired Tailor Made Compounding, whose compounding facility operates in 46 states. Other businesses are not waiting around for permission.
Some longevity doctors and medical clinics are selling peptides directly to patients, obtaining substances both domestically and from abroad. Alabama’s Board of Medical Examiners released a statement in May underscoring its stance against doctors “recommending, supplying, prescribing or administering these substances.” Wilson Hunter, the board’s general counsel, said the statement was prompted by unapproved peptides popping up in audits and investigations, via consumer complaints and as physicians inquire about guidance. “We’re not anti-peptide, we’re just anti people hurting themselves because they’re getting products that aren’t vetted or verified,” Hunter said.
In late July, the FDA’s Pharmacy Compounding Advisory Committee is set to discuss whether to greenlight seven unapproved peptides, including the popular BPC-157, for compounding pharmacies to use. It will hold another hearing early next year to discuss five more. In 2023, under the Biden administration, the FDA added them to a restricted compounding list, citing insufficient evidence to prove their safety and effectiveness. Earlier this year, the FDA removed them from that list.
If the seven peptides are officially added to the list of bulk drug substances compounders can use, that could represent a $2.2 billion telehealth market opportunity next year, according to an analysis by Leerink Partners senior research analyst Michael Cherny.
Mino, a new online platform for clinicians, doctors and med spas to access peptides and information about dosing, purchased a South Carolina factory that holds licenses to compounding pharmacies in various states, according to co-founder and CEO Elizabeth Straus. The factory prepared “Research Use Only” peptides, according to its website, which Straus said was the previous owner’s business model. Now the company, founded this year, touts its “pharmaceutical-grade inputs.”
Straus said Mino is currently providing certain peptides that remain in regulatory limbo in about half a dozen states. “Our lawyers feel it’s OK to do it under the right physician credentialing and infrastructure, and in the right states,” she said. She said Mino has no issues sourcing the ingredients. “When July 23 comes, do you think everyone is going to purchase APIs? They’re purchasing them right now.”
MSI previously reported that the FDA was set to weigh easing limits on unproven peptides favored by RFK Jr., and that the April hearing on the matter is part of a broader process documented in the agency’s public calendar.
Emily Hilliard, a spokesperson for the U.S. Department of Health and Human Services, said in a statement that “the prevalence of these substances on the black market and growing consumer awareness do not change FDA’s scientific or regulatory standards.” Hilliard reiterated the agency’s process, which includes the committee hearings beginning in July, and pointed to Secretary Kennedy’s April statement on the matter.
Protocole, a peptide telehealth company founded in 2025, announced in April it raised a $6 million investment round. Its pitch to consumers is “no unregulated ‘research use only’ products—ever,” its website promises, citing its products come from state-regulated pharmacies. Members pay around $200 to $300 per peptide, which includes meeting with a clinician to advise on their regimen. Its founders, Delphine Le Grand and Cindy Yan, met while working at a longevity clinic in New York City. On social media, Yan has promoted the transformative effects of GHK-Cu, known as the “beauty peptide,” on her skin.
Bill Holtz, a life sciences and FDA regulatory and policy strategist at Foley & Lardner LLP, said the compounding pharmacies producing the previously restricted peptides are doing so without explicit permission from the FDA. He described a delicate balance the federal government is trying to strike: navigating a regulatory process meant to keep consumers safe against the possibility that these experimental drugs could help people with certain conditions.
Next Health, a network of longevity-focused clinics, began offering peptides before the Biden-era regulatory changes. Dr. Darshan Shah, the company’s founder and CEO, said the changes resulted in a “hard stop” in the company being able to source restricted peptides from compounding pharmacies. But recently, he said, certain peptides such as BPC-157 have resumed production. Shah said Next Health works with a platform called Vitl, a health-tech startup that raised $7.5 million from investors last year, to vet and consolidate compounding pharmacies that produce peptides. Vitl founder and CEO Charlie Jordan said peptides are a small part of its business today but that interest from providers is high. “We get asked about it every single day,” he said.