Peptides: FDA Loosens Restrictions Despite Concerns From Scientists

• On the first day of a two-day meeting, an FDA advisory panel voted in favor of four 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 and scientists say the safety and effectiveness of injectable peptides marketed for wellness have not been adequately studied.

An advisory panel for the Food and Drug Administration (FDA) convened on July 23–24 to discuss whether seven peptides should be added to a list of drugs that compounding pharmacies are allowed to manufacture.

On the first day of the meeting, the Pharmacy Compounding Advisory Committee voted in favor of loosening restrictions on four peptides despite arguments from FDA scientists over their lack of safety:

• BPC-157
• KPV
• TB-500
• MOTS-c

Eight panel members voted yes for peptides BPC-157, KPV, and TB-500, while six voted no. One panel member abstained.

The peptides were evaluated for use in ulcerative colitis, wound healing, and inflammatory conditions.

For the peptide MOTS-c, seven members voted yes, five voted no, and two abstained. MOTS-c was evaluated for obesity and osteoporosis.

On the second day of the meeting, discussions on three other peptides — emideltide, epitalon, and semax —were underway.

In a reversal, the committee voted against adding emideltide, a peptide used as a sleep aid. The panel voted 7-to-4 in favor of expanding access to

In a final 8-to-5 vote with 1 abstention, the committee ruled in favor of broader access to semax, touted as a treatment for neurological conditions.

Eased restrictions on peptides mean compounded versions can be sold in the United States with a prescription from a pharmacist.

The FDA panel’s vote in favor of peptides would still need to be approved by the agency’s administrators.

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 about compounded 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.

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

A group of FDA scientists posted

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.”

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

The Biden administration placed

There have been

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.”

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.