Education Hub Peptides
The United States Department of Health and Human Services (HHS) has announced an interim policy that will flood the market with six unapproved peptides—BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500—despite U.S. Food and Drug Administration (FDA) scientists’ earlier recommendations against allowing their use in compounding.
To be clear, these substances have not been approved by the FDA, as they lack the necessary human clinical evidence and carry unknown safety concerns.
Yet under this new policy, HHS is allowing pharmacies and physicians to mass compound the peptides—ignoring scientific perspectives and effectively endorsing these unapproved products and their associated risks. Furthermore, this step undermines the United States’ scientific gold standard that is in place to protect patients.
HHS is arguing that by creating a pathway for peptides to be compounded, they are taking steps to protect Americans who may be seeking these products out on the gray or black market. But in reality, HHS is making it easier for peptide sellers to put patients in harm’s way with dangerous products.
Just because a product is permitted to be compounded does not make it safe.
Legal permission to compound a substance is not a stamp of approval for its safety. The growing market for testosterone illustrates this point. In 2026 alone, hundreds of thousands of compounded testosterone products have been involved in various recalls due to sterility and particle contamination concerns. Testosterone can legally be compounded under certain conditions, yet legally compounded versions still pose serious safety risks.
HHS’ decision to allow the compounding of peptides will not make them any safer for patients. Rather than cracking down on dangerous peptide sales, HHS is opening the door to a larger market for unapproved products, raising a critical question: is this policy prioritizing patient safety or the business interests of peptide sellers?
Patients should not be treated like guinea pigs, exposed to unproven products in the hope that real-world results will eventually justify their use. This is a dangerous approach that puts patients at needless risk.
The risks
Unapproved peptides are being sold on promises that science has yet to substantiate. From injury recovery to anti-aging, sellers are promoting products with a glaring lack of clinical evidence. Misleading marketing, substandard product quality, and gaps in oversight are exposing consumers to serious risks.
Meanwhile, unapproved peptides have gained massive exposure on social media. As of May 2026, peptide-related content had amassed more than 230 million views on TikTok. With these products gaining visibility online, misleading claims risk outpacing credible safety information, leaving consumers with a dangerously incomplete picture of what they’re putting into their bodies.
Many experimental peptides lack any human clinical trials establishing their safety, effectiveness, and appropriate use. Patients are being exposed to products with critical unanswered questions about their effects on the human body.
Critical safety questions remain about life-threatening adverse reactions including anaphylaxis, immune responses, appropriate dosing, drug interactions, and long-term health consequences such as cancer.
Sellers have long promoted unapproved peptides for weight loss, injury recovery, anti-aging, and numerous other uses, making sweeping health claims that go beyond the available scientific evidence. Consumers may be sold on promised benefits that may never come—without a clear understanding of the risks.
Peptide ingredients sourced from unverified suppliers, often overseas, raise serious safety concerns when quality and manufacturing practices cannot be confirmed. Gaps in oversight and traceability can expose patients to contaminated, mislabeled, or substandard products. Limited adverse-event reporting makes safety problems harder to detect and investigate.
The policy concern
Drug compounding is allowed in very limited and narrow circumstances: when an FDA-approved drug cannot meet a patient’s specific medical needs, such as an allergy to a particular ingredient. It is not intended to serve as a backdoor for bringing unapproved risky products to market without the rigorous testing required for FDA approval.
Yet HHS’ interim policy allows certain peptides to be compounded, despite questions about their safety and effectiveness.
Concerns about the compounding supply chain add another layer of risk. In a report, FDA found that 72% of enforcement actions against active pharmaceutical ingredient (API) manufacturers involved sites that solely supplied compounding pharmacies, though those sites represented just 18% of API manufacturers. These findings raise even more questions about the quality and oversight of ingredients entering the compounding supply chain.
Federal call to action
FDA must not allow unapproved peptides to continue to flood the market without sufficient human safety data, demonstrated clinical need, and a thorough evaluation of unresolved risks.
Enforce existing requirements for ingredient quality, prescribing, and adverse event reporting. Compounding must not become a workaround for the scientific review required to establish a drug’s safety and effectiveness.
Regulators must move beyond warning letters and take stronger enforcement action against unapproved peptide sales, like illicit retatrutide, misleading marketing, and unsafe overseas ingredient suppliers, including through import alerts, seizures, and prosecutions where warranted.
State call to action
Federal enforcement discretion does not override state laws or diminish states’ duty to protect patients. State boards of pharmacy, attorneys general, and other regulators must independently oversee pharmacy practices, enforce state laws, and crack down on unsafe or unlawful peptide sales.
State boards of pharmacy should rigorously enforce licensing, compounding, and dispensing requirements to prevent unapproved peptides from being distributed in violation of state laws or without required safeguards.
State attorneys general and regulators should investigate online peptide sales, deceptive marketing, and sellers promoting unapproved products, such as retatrutide, for human use under the guise of “research use only.” States must use their consumer protection and licensing authorities to hold bad actors accountable.
Learn more
Article
Americans for Safe and Effective Medicines (ASEM), a national advocacy organization dedicated to protecting patients from illegal mass compounding, counterfeit products, and misleading marketing, launched a new ad campaign in the Beltway this week to highlight patient safety concerns related to the U.S. Department of Health and Human Services’ (HHS) recent policy on the compounding of certain […]
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An issue brief examining the U.S. Department of Health and Human Services’ interim policy permitting the compounding of six unapproved peptides and highlighting concerns raised by key stakeholders.
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Unsurprisingly, reaction from the new HHS policy on the compounding of six unapproved peptides generated immediate reaction from a wide variety of stakeholders. But it’s how the pro-peptide community has reacted that’s worth a second look. Peptides = Profits Proponents of the HHS policy were quick to call out its financial impact. Early estimates trickled […]
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Americans for Safe and Effective Medicines (ASEM), a national advocacy organization dedicated to protecting patients from illegal mass compounding, counterfeit products, and misleading marketing, has issued the below statement on the interim policy announced in the Federal Register. Attributable to Fred Mills, PharmD, Chief Policy Officer, ASEM: “A legal pathway does not resolve problems with untested […]
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Americans for Safe and Effective Medicines (ASEM) has issued the below statement following CBS’ investigation of two deaths reportedly stemming from illicit products sold as retatrutide. Attributable to Fred H. Mills, Jr., PharmD, Chief Policy Officer for ASEM: “These deaths are deeply alarming and demand immediate investigation. While the circumstances surrounding these deaths remain unclear, […]
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20 groups and health care professionals say warning letters are not enough, call for seizures, injunctions, and a crackdown on distributors of illegal retatrutide (Washington, D.C.) September 29, 2026 – Americans for Safe and Effective Medicines (ASEM), along with 19 patient advocacy groups, physicians, and health care professionals has sent a letter urging Acting U.S. […]
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ASEM's letter, joined by 19 patient advocacy groups and physicians, to the FDA on the need for stronger enforcement against the mass-production and distribution of illegal retatrutide.
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Retatrutide cannot legally be sold anywhere in the world, but you would never know that based on the ease in which consumers can purchase products claiming to be the real thing. Before the medication has even completed the regulatory process, purported versions are already being advertised online and in storefronts, shipped across borders, and put […]
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Meta, the owner of social media platforms Facebook and Instagram, has announced it is putting new protections in place for young users. The company, which is taking these steps as part of an agreement with 52 attorneys general, is also calling on TikTok and YouTube to adopt the same protections. However, safety must extend beyond […]
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Criminals and illicit sellers have long exploited consumer demand for popular medicines. Today’s black market is increasingly sophisticated, using polished advertising, scientific-sounding language, and misleading health claims to make counterfeit and unapproved products appear legitimate. The consequences can be serious. Federal authorities have charged operators of fake pharmacies with allegedly selling counterfeit prescription pills to […]
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By Fred H. Mills Jr., PharmD., Chief Policy Officer, Americans for Safe and Effective Medicines Peptides are generating breathless headlines, viral social media testimonials, and sweeping, unfounded promises—but the noise is moving far faster than the evidence. The truth is that the science behind many of these products remains limited, and more rigorous research is needed before potential can […]
Read moreUnapproved peptides. Unknown safety risks. Patients deserve better.