Peptide gold rush: US policy shift exposes safety and regulatory gaps

Public comments on a US Department of Health and Human Services (HHS) policy allowing pharmacies to compound six injectable peptides close today. Some of the compounds have built an online following for promised beauty benefits, such as skin rejuvenation and hair growth.

Under a draft interim policy, issued in late October, HHS says it will not take enforcement action against licensed pharmacies, physicians, and federal facilities that compound the six peptides — provided they meet conditions covering ingredient sourcing, testing, and adverse event reporting. 

The new policy does not amount to FDA approval. None of the peptides have been proven safe or effective in large-scale human trials. 

The HHS’s latest move follows a July vote by the FDA’s Pharmacy Compounding Advisory Committee to back the compounds, overriding the agency’s own scientific reviewers, who discouraged approval. 

Regulators’ focus on injectable peptides stems from a rising “gray market,” where consumers are buying the unregulated substances through online sellers labeling them for “research use only.”

As the comment window closes, Personal Care Insights investigates why the US administration is easing access to the group of unapproved injectable peptides. We explore where the surge in interest has come from, what the policy means for the gray market, and what needs to happen next.

We speak to a board-certified dermatologist, a peptide advocate, and a patient safety group, who represent different sides of the injectable peptide debate.

Jay Campbell, co-founder of peptide company BioLongevity Labs, calls the current injectable market “a gold rush.” Amid the discussion over how tightly the substances should be regulated, Campbell argues that “adults are going to use peptides whether the FDA approves of them or not.” 

Campbell argues adults will use peptides regardless of FDA approval.

What is driving the attention?

Campbell says that the rise in GLP-1 use and “health sovereignty” has resulted in the increased interest in injectable peptides.

“First, GLP-1s went mainstream. Semaglutide and Tirzepatide proved to millions of people that a peptide could change their body… That pushed the door open, and mass interest in other peptides followed,” he explains.

“Second, countless numbers of young people have stopped trusting the ‘sick-care’ system to help them thrive, especially post-COVID. They see a medical model that puts profit first and waits for disease instead of optimizing health. So they go looking on their own and usually land on social media, where they encounter a mix of insightful and illegitimate [content].”

Dr. Marisa Garshick, MD, Fellow of the American Academy of Dermatology, agrees that there is a growing interest in injectable peptides by consumers looking to improve their skin, stimulate hair growth, enhance their appearance, or achieve a tan. She backs that social media is “one of the biggest concerns.” 

Garshick believes that social media is generating a casualness around the injections, making it seem like “just another step in a skin care or wellness routine. When in reality, injecting a substance into your body carries very different risks than applying a serum to your skin.”

Campbell also details that the online boom of “Looksmaxxing” is one of the “fruits of this movement.” “Looksmaxxing” refers to optimizing one’s physical appearance, but sometimes to extremes. It is mostly a culture of men.

The health optimization podcaster says that the online discourse of injectable peptides’ “loudest segment” is young men. Campbell describes that many young men feel pressure to project a masculine appearance. He believes that peptides are the most recent step in “decades” of developments in male physique culture. 

Despite injectable peptides being a male-dominated field, Campbell says women are a “huge and growing part of the market.” He says the offshoot is more focused on skin, hair, body composition, and longevity rather than “maxxing.”

Garshick warns that injecting peptides carries risks beyond topical skin care.

Safety and substantiation?

Although the push to relax the rules on injectable peptides is seen as a way to curb the “gray market,” the FDA’s own scientists recommended against all seven compounds.

Garshick says that one of the biggest misconceptions surrounding injectable peptides is that because they are marketed as part of the body’s own repair processes, they must be safe. “However, natural does not necessarily mean safe, especially when substances are injected at doses or frequencies that haven’t been properly studied,” she says.

She adds that while the personal care industry should be encouraging innovation in dermatology, “safety and scientific evidence need to come first.”

“It’s important not to get ahead of the research. There is a difference between promising early laboratory findings and treatments that have been proven safe and effective in clinical trials.”

Campbell at BioLongevity Labs defends the compounds, saying the FDA applied a standard that, “by design, almost no non-patentable compound can meet.”

“Large human trials cost hundreds of millions of dollars. Nobody funds them for a peptide they can’t patent. So the absence of those trials gets cited as the reason to restrict it, but that’s circular logic,” he says.

Of the peptides in question, the FDA’s reviewers found no human safety studies for KPV, TB-500, MOTS-c, or Epitalon, and concluded there was insufficient clinical safety information to characterize the safety profile of BPC-157.

Campbell argues that the lack of large-scale trials does not mean the evidence is absent. He cites preclinical research on BPC-157, human trials on thymosin beta-4 (TB-500’s parent protein), Semax’s approval in Russia, and years of use among athletes and bodybuilders.

He also disputes the FDA staff’s concerns about immunogenicity — the risk of the body’s immune system reacting to a substance. According to Campbell, that concern applies mainly to large biologic drugs rather than short-chain peptides such as BPC-157.

Campbell reads the advisory committee’s vote, which went against the staff recommendation on six of the seven compounds, as a sign that “the evidence is more substantial than the staff review suggested.”

Verbois says compounding access cannot replace enforcement against online sellers.

How consumers gain access 

Injectable peptides sold online have a “research use only” label, giving sellers a way to stay outside drug regulations. The FDA has sent a string of warning letters this year to online peptide vendors, arguing that what matters is how a product is marketed, not the disclaimer on the label. 

Alliance for Safe Online Pharmacies (ASOP Global) Board Chair Dr. Leigh Verbois tells Personal Care Insights that the use of “research use only” or “research-grade” language is an important concern because it can create an appearance of legitimacy — appealing to consumers seeking health, wellness, or cosmetic benefits.

Since July, ASOP Global’s Rx Watchdog has identified over 20,900 online listings across 330 websites for emerging peptide molecules that cannot currently be legally compounded under the applicable framework. BPC-157 accounts for a “substantial share” of those listings. 

“As policymakers consider changes to peptide compounding, they should keep two priorities in view: ensuring that legitimate medicines meet appropriate standards for efficacy, quality, and safety and addressing the illegal online market that operates outside those safeguards,” says Verbois.

Meanwhile, Campbell believes the “truly dangerous mistake” people partaking in injectable peptides make is buying from the gray market vendors with no third-party testing or transparency into compound quality and purity. “You have no idea what’s in the vial, how much of it, or whether it’s contaminated.”

Campbell’s business sits in the gray market he describes. BioLongevity Labs publishes protocols for using the compounds. When asked whether that makes him part of the problem, he says his aim is the opposite.

“My entire mission with respect to peptides is to champion smart, safe, and responsible administration for the people who want to use them,” he says. “What we have right now is a market full of bad actors and money grabbers, and it is contributing to a genuine public health crisis. No one wants to fix this more than I do.”

Garshick cautions that “natural” peptides are not automatically safe to inject. 

Approval and gray market 

Campbell says allowing compounding pharmacies to make these peptides would pull “some, [but] not all” consumers away from gray market sellers. He says some people will pay for the prescription, clinic visit, and pharmacy markup required to gain access, while many won’t, and online vendors will continue to win on price and convenience.

“The real win from compounding access is quality. It creates a legal, regulated benchmark, and every legitimate supplier should welcome that, because it exposes the vendors cutting corners.”

ASOP’s Verbois agrees that a legal pathway for certain compounded products would not automatically eliminate the online market for unapproved or illegally marketed products. 

“Even if a peptide becomes eligible for compounding under a revised policy, that would not make every product sold under that name lawful, FDA-approved, or safe and effective. It would not automatically remove existing listings, stop misleading claims, verify the identity or quality of products sold online, or hold unauthorized sellers accountable,” she says. 

“Our concern is that expanded access and enforcement are being treated as if one can substitute for the other. They cannot. Patients need access to appropriate, quality-controlled medicines, but authorities must also address sellers that operate outside applicable legal requirements.”

“Changes to compounding policy should be accompanied by meaningful action against illegal online sales and the infrastructure that facilitates them.”