Peptides could soon be easier to get in the United States. Here’s what to know

By Jacqueline Howard, CNN

(CNN) — The US Department of Health and Human Services posted a draft policy that would ease restrictions about how certain peptides may be created in the United States, essentially opening up access to them.

Some wellness advocates applauded the move, while others have raised concerns.

Here’s what to know about peptides and what the change could mean.

What are peptides?

Peptides are short chains of amino acids and act as the building blocks of proteins in the body. Some are important prescription medicines. Insulin, for example, is a peptide, as are GLP-1 medications widely used to treat diabetes and obesity, such as Ozempic and Wegovy.

But the six injectable peptides that are included in the new draft HHS policy are different. They’re popular among wellness influencers, elite athletes and some doctors, who say they can help reduce inflammation, improve recovery, promote longevity and boost overall health.

But they’re not approved by the US Food and Drug Administration, meaning they have not been evaluated to meet certain safety, quality and effectiveness standards through the FDA approval process. Currently, some consumers get them through an unregulated gray market, without ever consulting a physician — a potentially risky option.

In July, the FDA’s Pharmacy Compounding Advisory Committee narrowly supported opening the door for six peptides to be created by compounding pharmacies:

• BPC-157, proposed for treating ulcerative colitis
• KPV for wound healing and inflammatory conditions
• TB-500 for wound healing
• MOTS-c for obesity and osteoporosis
• Semax for certain neurological disorders
• Epitalon for insomnia

They wouldn’t be approved by the FDA — the agency doesn’t review compounded drugs for safety, effectiveness or quality before they are marketed — but HHS argues that they could still improve safety.

“Secretary Kennedy is acting on that recommendation with a draft interim policy with a 14-day comment period supporting patient-specific compounding in the U.S. under applicable state and federal oversight,” HHS spokesperson Emily Hilliard said in an email Wednesday.

“The policy does not grant FDA approval or establish clinical safety and effectiveness,” Hilliard said. “It requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting to hold compounders accountable and give patients an alternative to unregulated sellers.”

What does the new policy say?

“Compounding is generally a practice in which a licensed pharmacist, a licensed physician or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes or alters ingredients of a drug to create a medication tailored to the needs of an individual patient,” the policy said.

So far, people who use peptides have been able to order products like BPC-157 or TB-500 from places like unregulated websites without ever seeing a doctor. With the interim policy, people seeking peptides would need a doctor’s prescription to get them from a licensed compounding pharmacy.

Although the peptides wouldn’t be FDA-approved or even officially on the list of substances that compounders can prepare, “HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using” one of the six peptides, the new policy said.

“The Secretary of HHS has determined that this limited enforcement-discretion policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients. By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative,” the policy said.

The draft policy appears to target the gray market until a separate final rule addresses whether a peptide is or is not included on the list of ingredients that compounding pharmacies may use to prepare customized medications under specific legal conditions.

After the 14-day comment period for the draft policy, HHS is expected to issue that final policy.

“Although compounded drugs can serve an important medical need for certain patients, they also may pose risks to patients,” the draft policy said. “However, based on the Pharmacy Compounding Advisory Committee (PCAC) meeting and data regarding utilization of peptides, HHS believes that there is significant interest in the use of these peptides in compounding.”

What are the arguments for and against?

When the FDA advisory committee met in July, its members narrowly agreed to support easing restrictions on the six peptides.

Many of the members who voted in favor argued that doing so would lead to a safer pathway through which people could access the drugs.

“Keeping this in a regulated pharmacy is not the risk in the room. The gray market pipeline is, and it operates in the open because we let it,” said committee member Dr. Hal Mohammed, global chief medical officer of Gameday Men’s Health. “Myself as a physician, I have to make sure that I’m keeping patients as safe as possible. That’s my mandate: Do no harm.”

But many of the committee members who voted against making the peptides more accessible through compounding argued that there is a lack of evidence and research to suggest that the approach would stop the gray market, and that there are still some unknowns around the effectiveness and risks of certain peptides.

“I’m concerned that we’re responding to a market-induced demand rather than a decision based in solid science,” said committee member Dr. Elizabeth Rebello, of the University of Texas MD Anderson Cancer Center.

Shabbir Imber Safdar, executive director of the public health coalition Partnership for Safe Medicines, said in a statement Wednesday that the draft policy makes it unclear whether peptides are safe or not, “even though the FDA’s own scientists recommended against voting in favor of these substances due to concerns with evidence.”

Last week, the coalition filed a citizen petition urging the FDA to block the compounding of peptides.

“The Administration’s decision comes after a vote from the FDA’s Pharmacy Compounding Advisory Committee in support of compounding six ‘wellness’ peptides. However, overlooked in this vote is that many newly appointed PCAC members appear to have conflicts of interest directly related to the peptide substances under consideration,” Safdar said.

“This outcome shreds any sense of credibility and transparency, placing their interests above the safety of the American people,” Safdar said. “The Administration should change course and focus on prosecuting the bad actors who have been illegally producing and distributing dangerous products to the public.”

The American Peptide Association, which supports the peptide industry, applauded the new draft policy.

“It is much needed clarity that the peptide industry, clinicians and consumers have hoped and worked for for the past couple years and is a bold step outside the usual pharma driven, FDA managed pathway,” Jeff Cohen, co-founder of the association, said in a written statement.

What does this mean for people already using peptides?

The draft policy is “potentially good news” for people who want to access peptides through a prescription, says Jay Campbell, co-founder of BioLongevity Labs and author of the book “Optimize Your Health With Therapeutic Peptides.”

“A physician would be able to prescribe compounds like BPC-157, TB-500, and Semax and have a licensed pharmacy fill it without the threat of federal enforcement. But it’s potentially bad news for the millions of people who get their peptides from the direct-to-consumer marketplace today. This policy only covers compounded prescriptions, which will start to carry higher prices,” Campbell, who also uses peptides himself, said in an email Wednesday.

“As demand rises, these peptides could get substantially more expensive, especially if access at the direct-to-consumer level is restricted or cut off. Pharmacies will also have to source from FDA-registered manufacturers and run full quality testing, and those costs get passed on to the patient,” he wrote. “People who have been paying research-market prices should be prepared for a very different bill at the pharmacy counter.”

Cohen from the American Peptide Association said there are still unanswered questions for people already using peptides.

“While the recent regulatory pathway being paved for consumers who want to be clinician led is well served by the recent change, the pathway for consumers who do not want to be clinician led remains obscure,” Cohen said. “Those consumers do not receive clinical guidance from clinicians, and their products do not come from compound pharmacies. They come from non pharmacy manufacturers, where the safety and quality can be unregulated and spotty.”

The Alliance for Pharmacy Compounding, the industry’s trade association, said it welcomes HHS’s move.

“We’ve said all along that the question isn’t whether patients are using these peptides. They are. The question is where they’re getting them,” CEO Scott Brunner said in a statement Wednesday. “Right now, far too many patients are obtaining peptides from illicit suppliers with little assurance about what’s actually in the vial. That’s an existing public health threat, and one that isn’t going away simply because compounding of the substances is prohibited.”

The alliance noted that the draft policy includes some safeguards it called for, including “extensive testing and documentation, and reporting of serious adverse events and product quality issues.”

But it said it would seek clarification from HHS on issues like how the policy will be coordinated with state boards of pharmacy and when the policy takes effect.

“A credible federal policy with meaningful patient-safety safeguards gives states a sound basis for their own oversight and helps discourage a patchwork of state rules and restrictions that could undermine the access HHS is trying to provide,” Brunner said.

CNN’s Brenda Goodman contributed to this report.

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