Our website uses cookies to provide your browsing experience and relevant information. Before continuing to use our website, you agree & accept our Cookie Policy & Privacy.

The FDA May Reverse a Ban on Several Peptides With Potential Beauty Benefits. What Does That Mean, Exactly?

allure.com

The FDA May Reverse a Ban on Several Peptides With Potential Beauty Benefits. What Does That Mean, Exactly?

Peptides are everywhere: in your favorite serum, on your TikTok FYP, and for many people, injected as part of a “stack” meant to help reduce appetite, stimulate muscle growth, or (purportedly) support longevity, often with code-like names of capital letters and numbers trailing behind. While GLP-1 is definitely the most famous peptide in the game—either you’re on one or know someone who is—a new group of peptides may be making their way into our collective consciousness, if current Health Secretary Robert F. Kennedy, Jr. has his way.

As reported by the New York Times, the Food & Drug Administration (FDA) is likely to lift prior restrictions on a handful of previously banned peptides, in part due to urging from Kennedy. (A meeting to evaluate seven of these peptides is set for July.) This, however, does not mean that the peptides would automatically receive FDA approval. In 2023, the 14 peptides in question were removed from production due to potential safety risks and include several with alleged beauty benefits. But as the NYT notes, though the 14 peptides were technically restricted by the government—meaning compounding pharmacies were not allowed to produce them—consumers could still purchase them via the online “gray market” and play doctor from the comfort of their kitchen.

What are Peptides, Anyway?

Let’s back up a bit. The word “peptide” has become a mainstay of skin-care marketing lingo and collagen drink mixes, but what do peptides actually do? “Peptides are best understood as targeted signaling molecules. They tell the body to upregulate processes it already knows how to do, such as repair, regeneration, or metabolic regulation,” explains Amanda Kahn, MD, a board-certified internist in New York City.

“In practice, they can support areas like body composition, recovery, skin quality, hair growth, and inflammation when used appropriately.” (Peptides that you apply topically may have limited penetration into the skin, depending on formulation.)

But what peptides cannot do, she adds, is “act as a replacement for foundational health.” Peptides are not a substitute for things like proper nutrition, sleep, and medical care, Dr. Kahn continues, adding that patients are drawn to the “precision and personalization” of peptides, which allow for a more tailored approach to treatment.

GLP-1s have dominated the peptide game—and the cultural conversation—for the past few years, but Jeffrey Lee, MD, a board-certified plastic surgeon in Boston, notes that there are many others emerging, and they may have a “wide range” of effects. Some of the restricted peptides may have potential benefits for immune function, healthy aging, healing, and metabolism, he says, and many others are “being explored for similar benefits related to overall tissue health.”

Which Peptides are on the Banned List?

Included on the “banned” list is epitalon, which claims to support hair and scalp health; GHK-Cu, which reportedly provides antioxidant and anti-inflammatory benefits; KPV, which may help reduce skin conditions like eczema; and Melanotan II, which has been used to increase tanning abilities. While these claims sound promising (except for the one that makes it easier to tan), the 2023 FDA findings reveal that these peptides may come with significant safety risks; for example, Melanotan II can increase the risk of melanoma. Others, like KPV and GHK-Cu, don’t have adequate safety data in humans.

When we say peptides are everywhere, we mean it. “Every pharmacy here in Los Angeles… is formulating them and distributing them,” says Ava Shamban, MD, a board-certified dermatologist in California. “And all over the country, for sure, even though they're not approved by the FDA.” Dr. Shamban, who has served as a clinical investigator on many FDA trials, notes that when a product is approved by the FDA, it first requires a “fairly expensive” trial process. “The fact that these [peptides] are widely available means there's no one company that started taking the reins and saying, ‘We're going to take this combination and then we're going to study XYZ,’” she explains. The other issue would be limiting variables like exercise level, nutrition, and sleep, which can also impact improvement, she notes. “That’s what’s really going to prevent them from ever getting the FDA-approved form.”

Peptides and the Gray Market

We know what you’re wondering: If a product does not have the FDA’s blessing and is thus technically not allowed to be sold, how are people getting their hands on it in the first place? (Especially when, in some states, you need to show ID to buy something as simple as spray paint.) According to Dr. Kahn, peptides that are labeled “for research only” are often sold online through unregulated vendors, and can “bypass traditional medical and pharmaceutical oversight,” thus serving as a legal loophole; this is also how these peptides end up in the gray market. “Many of the peptides that have been restricted are still technically available under a ‘for research purposes only’ designation,” says Dr. Lee. “In practice, some consumers purchase them through this loophole and use or distribute them outside of a true research setting,” he explains.

Gray market products exist in an in-between space, since they’re not exactly illegal, but are rather “obtained through channels that lack proper authorization for personal use,” Dr. Lee says. This also means they’re not subject to safety, quality, and purity testing. You can, at this very moment, purchase many of the peptides on the restricted list online. Some vendors require specific credentials to make said purchase or require you to check a box saying your purchase is for research purposes only and not intended for human and animal use, while others include similar language on each peptide product page.

How Peptides are Prescribed, Compounded, and Acquired

And where do doctors factor into all this? “If you’re able to purchase a peptide online without seeing a doctor, without a prescription, and without any credentialing, that should absolutely raise red flags,” says Dr. Shamban. “Legitimate peptide therapies [like a GLP-1, for example], intended for human use require medical oversight and must be dispensed through licensed pharmacies. When none of those safeguards are in place, you’re operating completely outside the medical system.”

When prescribed by a doctor, peptides “must be sourced from approved bulk substances or supported by a clear clinical justification,” adds Dr. Shamban. “These pharmacies operate under FDA oversight and can only dispense to licensed providers; these are not products available directly to consumers.”

Some of the peptides not on the FDA ban list, like the very famous GLP-1, have FDA approval, while others exist outside the sphere of approvals; you can acquire them, but they don’t come with the safety assurances an approved product does. “Not all peptides are FDA approved, but when prescribed by a licensed physician and dispensed through a regulated U.S.-based compounding pharmacy—503A or 503B—they are used in clinical practice under medical supervision,” explains Dr. Kahn. “Many peptides used in medicine are compounded formulations, meaning they are customized rather than commercially approved drugs.”

While semaglutide is FDA approved, not all peptides produced at compounding pharmacies are. “Most of these compounds still lack robust clinical data proving their safety and long-term efficacy,” Dr. Lee says. “At this stage, much of what’s circulating is anecdotal: people reporting personal use without clear, evidence-based conclusions about risks or side effects.”

“Legitimate compounding pharmacies operate under strict regulatory frameworks and work only with licensed prescribers,” explains Dr. Shamban. These facilities cannot legally compound or dispense restricted or banned peptides for safety reasons. That hasn’t stopped some compounding pharmacies, though; one peptide on the restricted list that Dr. Shamban often sees in Los Angeles is BPC-157 (a.k.a. Body Protection Compound), which is derived from gastric juices and typically used for workout recovery; you can easily buy it online for about $120. “While these products may be easy to find online, that convenience often comes at the expense of safety,” she explains. “Easy access does not mean safe or appropriate for human use.”

It is illegal; enforcement is just currently a game of whack-a-mole. The patient demand greatly outweighs the federal government's appetite to enforce so we are in a unique legal environment.”

The Legality of It AllSo how are pharmacies legally selling and distributing peptides on the restricted list? Well, they shouldn’t be. “Peptides on the FDA’s ‘restricted’ list are not allowed to be compounded. Period!” says George Hajduczok, a medical device and pharmaceutical product liability and regulatory affairs attorney based in Buffalo, New York. “When the FDA places a peptide in a restricted or high-risk category [also known as Category 2], it is explicitly signaling that it has identified safety concerns and that enforcement discretion does not apply.” However, he notes, just because something is “not FDA-approved” doesn’t mean it’s “illegal to compound.” However, the “restricted” peptides should not be compounded.

Take, for example, BPC-157, or the “recovery” peptide currently on the restricted list. David J. Holt, attorney and owner of Holt Law, a healthcare business law firm in Minnesota and California, points out that it was moved to Category 2 in 2023, so “legally, compounding pharmacies cannot distribute it for human use.” But they’re using that “for research purposes” loophole to distribute it. “They claim the product is for research or not for human consumption to dodge FDA jurisdiction,” he shares. “The FDA looks to the intent, not simply what you say as an alleged legal loophole. Selling a research peptide to a patient for a workout injury is misbranding and distributing an unapproved new dru

  • Last
More news

News by day

Today,
28 of May 2026

Related news

More news