FDA May Ease Restrictions On Compounded Peptides Despite Safety Warnings

• An FDA advisory panel is expected to vote on whether to allow seven types of peptides to be sold as compounded medications.
• Proponents describe wellness peptides as a “fountain of youth” that can promote healing from injury and improved overall wellness.
• Doctors say the safety and effectiveness of the peptides have not been adequately studied.

An advisory panel for the Food and Drug Administration (FDA) will decide this week whether to loosen restrictions on seven peptides that proponents say can improve health and wellness.

If restrictions are eased, the peptides could then be prepared and sold as compounded medications with a prescription by pharmacies in the United States.

The advisory panel’s meeting is scheduled for July 23–24. Their recommendation would still need to be approved by FDA administrators.

The seven peptides on the agenda are:

• TB-500
• BPC-157
• Semax
• Epitalon
• Emideltide
• KPV
• MOTs-C

The peptides are being reviewed as potential treatments for conditions such as ulcerative colitis, wound healing, obesity, and migraine.

Peptides have been promoted by Health and Human Services Secretary Robert F. Kennedy Jr., who has said he’s used the peptides in the past to help heal from injuries.

Other proponents describe peptides marketed for wellness as a “fountain of youth” that can improve muscle mass and increase longevity, among other benefits.

Katrin Svensson, PhD, an associate professor of pathology at Stanford University, urges caution as the FDA evaluates peptides.

“I think it’s important to separate the promise of peptide therapeutics from the evidence supporting any individual peptide,” she told Healthline. “Peptides are a very promising class of drugs and several have transformed the treatment of diseases such as diabetes and obesity. However, that does not mean every peptide being marketed has been adequately studied.”

“I don’t think the question is whether peptides are good or bad. The question is whether there is sufficient scientific evidence for each specific peptide,” Svensson added.

Mir Ali, MD, a bariatric surgeon, bariatric medicine specialist, and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in California, said making compounded versions of the peptides might provide the medical community with more information.

“I think it might be a good idea to broaden the application of these medications so we have a better ability to evaluate them,” he told Healthline.

Doctors concerned about safety of peptides

Not everyone is convinced of the safety and effectiveness of peptides.

A group of FDA scientists has posted documents raising concerns about the peptides’ safety and the lack of scientific review of the substances.

Bert Mandelbaum, MD, a sports medicine specialist, orthopedic surgeon, and co-director of the Regenerative Orthobiologic Center at Cedars-Sinai Orthopedics in Los Angeles, told Healthline in a recent interview that so-called “wellness” peptides are neither safe nor effective.

“This has nothing to do with wellness,” he said. “I would call it more of an uninformed fad. It’s worse than that — it’s criminal. The influencers, including RFK Jr., are abusing the system and not following the science.”

David Cutler, MD, a family medicine physician at Providence Saint John’s Health Center in California, is also adamantly opposed to easing restrictions on these peptides.

“There has never been a systematic study on the benefits and risks,” he told Healthline. “No one has looked at the adverse effects they might have on humans.”

Svensson said the lack of information on these peptides is also her biggest issue.

“My biggest concern is how little we know about many of these molecules,” she said. “For a large number of experimental peptides, there are very limited pharmacology and toxicology data. We often don’t know what happens with chronic administration, whether they accumulate in tissues or whether they have effects outside their intended target.”

What to know about peptides

Peptides are short chains of amino acids that act as a signaling molecule that sends a message to the body to carry out certain functions.

Most are administered by injection and have been touted as helping with injuries, muscle recovery, metabolism, and skin care.

GLP-1 medications and insulin are peptides. The drugs are approved by the FDA as treatments for obesity and diabetes.

There are compounded versions of GLP-1 medications, but FDA officials issued a warning in June about the safety of these drugs. They said these medications should only be used by patients whose medical needs cannot be met by an FDA-approved drug.

The Biden administration placed restrictions in 2023 on 19 peptides, including the seven currently under consideration, moving them into a category that effectively prohibits compounding pharmacies from making them.

There have been past studies showing the benefits of peptides, but most of that research has been conducted on animals, not humans.

Ali said there are indications that certain peptides could be beneficial. “Some of them have shown promise to have broader applications to humans,” he said.

He added that more research is needed into the peptides that are currently banned by the FDA. “We don’t the full extent of the risks, benefits, and side effects of these medications,” he said.

Svensson agreed. “I think peptides have enormous therapeutic potential, but I also think they should be held to the same scientific standards as any other drug,” she said. “Being a naturally occurring peptide does not imply that it is effective or safe.”

“These are biologically active compounds,” added Cutler. “As biological agents, they could be beneficial or they could be harmful.”

What to use instead of peptides

Mandelbaum said there are a variety of orthobiological compounds that have been proven safe and effective for supporting healing.

He added that building in recovery time in your exercise regimen, as well as quality sleep, can also help prevent injury.

Ali noted that anti-inflammatory medications such as ibuprofen can also be beneficial. He said that a patient should discuss any planned medication routine with their primary care physician.

Cutler stressed that there are plenty of treatments that are “well established” and can be used while a person waits for the scientific evidence on these peptides.

“They should want a scientific evaluation before putting anything in their body,” he said.