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Proceed with caution…

Reviewed by Dietitian Madeline Peck, RDN, CDN

Key Points

• Peptides are short chains of amino acids that can be made synthetically for medical purposes.
• An FDA committee just voted to ease regulations on six popular peptides.
• There are still many unanswered questions about their safety and long-term effects.

If you’re unfamiliar with the latest peptide craze, a quick Google search will do the trick. You’ll find fitness influencers, celebrities and even Health and Human Services Secretary Robert F. Kennedy, Jr., touting their purported benefits. And with names like GHK-CU, Thymosin Beta-4 and MOTS-c, it can feel like you’re deciphering a secret code when scanning through the names of some of the internet’s most talked-about peptides.

Peptides have been praised for their supposed ability to support everything from wound healing and metabolism to digestion, sleep and healthy aging. Until recently, many of the peptides making the rounds on social media could only be legally manufactured and sold for research purposes, which meant people who are already using them were often turning to online retailers operating in a “gray market.”

That’s why the U.S. Food and Drug Administration (FDA) recently held a meeting to discuss whether several of these popular peptides—seven, to be exact—should be allowed for broader use. And while FDA scientists were against expanding access to the substances, the agency ultimately recommended that six peptides be added to the compounding eligibility list—meaning they may soon become much easier to access through regulated sources.

Here’s what the science says and what you should know about these controversial products before you decide to seek one out for yourself.

What Are Peptides?

If you’re unfamiliar with peptides in general, you’re probably more familiar with some specific varieties than you realize. Some of the most well-known peptide medications include insulin, oxytocin and GLP-1 medications like Ozempic. Essentially, peptides are short chains of amino acids (the building blocks of protein) that occur naturally in the body and can also be made synthetically for medical and research purposes.

The difference between these widely recognized peptide medications and many of the newer peptides trending online is that they’ve undergone rigorous testing in humans and are FDA-approved for specific uses. They also have established manufacturing standards, dosing guidelines and safety data. Many of the peptides gaining traction on social media haven’t gone through that same level of testing, which is one big reason why they remain controversial.

What Does the FDA Decision Mean?

Because research peptides have become so popular in the ever expanding wellness and longevity conversation, the FDA’s Pharmacy Compounding Advisory Committee (a group of outside advisers to the FDA) held a two-day meeting at the end of July to evaluate whether seven of the most popular wellness peptides should be added to the agency’s 503A bulks list. The bulks list compiles ingredients that licensed compounding pharmacies are allowed to use when making customized prescription medications, even if the ingredient isn’t part of an FDA-approved drug.

Simply put, adding a peptide to the bulks list means that licensed compounding pharmacies can legally prepare and dispense it to people with a prescription, making it much easier for consumers to access legally than when it was confined to the research market.

It’s important to note that FDA scientists did not support expanding access to the seven peptides. In documents submitted ahead of the two-day meeting, they argued that there is little clinical data demonstrating the peptides’ effectiveness for their promoted uses and that important questions about their long-term safety remain unanswered.

Going against the FDA scientists’ recommendations, the advisory panel voted narrowly to recommend adding six of the seven peptides to the compounding eligibility list. That doesn’t mean the peptides have officially been added to the 503A bulks list just yet. The committee’s vote is advisory, meaning the FDA must still review the recommendation and decide whether to move forward with any regulatory changes.

Which Peptides May Get Approved?

The six peptides that were recommended to be added to the compounding eligibility list—and the uses they’re most commonly promoted or studied for—include:

• BPC-157: Gut health and connective tissue repair
• KPV: Anti-inflammatory effects and gut health
• TB-500: Tissue repair and wound healing
• MOTS-c: Glucose metabolism and muscle health 
• Semax: Cognitive function
• Epitalon: Sleep

Emideltide, which has been investigated for insomnia and pain relief, was the seventh peptide discussed during the meeting. However, it was the only one that was not recommended to be added to the compounding eligibility list.

What Are the Risks?

If you’re wondering why this decision has been so controversial, here’s one reason: In 2023, the FDA placed these six peptides—along with 13 others—on a list of substances it considered too risky for compounding pharmacies to use. Then, somewhat unexpectedly, the agency removed the seven peptides discussed at this recent meeting from the high-risk list in April, paving the way for the advisory committee to potentially loosen regulations.

FDA scientists say there’s still little to no clinical trial data supporting the safety or effectiveness of these peptides for their promoted uses, as most of the research done thus far has been animal research. They also note that peptides carry a relatively high risk of triggering immune reactions, including serious allergic responses like anaphylaxis, because the body may recognize them as foreign substances.

There are plenty of other unanswered questions, too. Researchers still don’t know whether these peptides are safe for people with certain health conditions, whether they interact with common medications or whether their safety and effectiveness differ depending on how they’re taken, such as by injection, oral capsule or nasal spray.

Additionally, because these peptides haven’t gone through the same rigorous testing as well-known peptide medications like insulin or GLP-1 drugs, there are still significant gaps in what we know about their safety and effectiveness. Manufacturing quality can also vary depending on where the peptides come from, increasing the risk of impurities or inconsistencies in the final product.

Are There Any Benefits?

While scientists have raised concerns about expanding access to these peptides, there is a potential benefit. Until now, people seeking these products have relied on online retailers operating through a “gray market,” where product quality and purity can be difficult to verify.

If the FDA ultimately accepts the advisory committee’s recommendation, people obtaining these peptides through licensed pharmacies can rest assured that the products were prepared under sterile environments and contain the specific peptide they claim to contain. That could reduce some of the risks associated with purchasing peptides from unregulated online sources. Still, it doesn’t change the fact that there are still significant questions about their safety and effectiveness.

Our Expert Take

The advisory committee’s vote on these six peptides is not binding—it’s a recommendation. Before any of these peptides can officially be added to the 503A bulks list, the FDA must review the committee’s advice and decide whether to accept, modify or reject it.

For now, we’re choosing to follow the recommendations of FDA scientists and proceed with caution. While these six peptides may become more accessible in the future, there are still major unanswered questions about their safety, effectiveness and long-term effects. At this point, there is no clear timeline for when the FDA will announce its final decision on whether these peptides will be added to the 503A bulks list. Until then, it’s important to keep in mind that increased access does not necessarily mean a product has been proven to be safe or effective.