Consumers Will Pay the Price if FDA Opens the Door to Six Untested Peptides
Media Contact: Lisa McDonald, Vice President of Communications, 202-207-2829
Washington, DC – At a time of mounting concern that gray-marketed injectable peptides carry severe risks to human health, the National Consumers League is raising alarm bells that an “interim access policy” poised to be issued by the Food and Drug Administration (FDA) will allow compounding pharmacies to make and sell six currently banned peptides – BPC-157, TB-500, KPV, MOTS-c, Epitalon, and Semax – despite FDA’s own scientists warning that the evidence behind these substances consists largely of small animal studies and laboratory experiments, not the rigorous testing Americans expect from the medicines they put into their bodies.
Specifically, NCL cautions that instead of undergoing a full rulemaking process, the interim access policy would put these untested peptide products on the market without the public comment and scientific review that the law intends. In doing so, FDA would allow specific “503A pharmacies” that prepare customized medications and are exempt from the safety and labeling rules required for FDA-approved medicines to compound these peptides for any use a prescriber supports. FDA’s argument is that patients already buy these peptides from illicit sellers, and thus an interim enforcement discretion policy will allow licensed pharmacies to compound higher-quality products under professional oversight.
The harm to consumers from this “might as well” policy is incalculable. The FDA has warned that immune responses to peptides range from silent antibodies to “life-threatening and catastrophic reactions,” which is why the agency placed the six peptides in Category 2 for significant safety risks, precluding their use. Additionally, the American Medical Association, other medical societies and global bodies including Health Canada, Australia’s Therapeutic Goods Agency, and the World Anti-Doping Agency have all warned that inadequately tested peptide products are a growing public health risk. Among the dangers are liver toxicity, cardiovascular stress, potential tumor promotion, and severe allergic reactions, ranging from skin-swelling and hives to life-threatening anaphylaxis.
Beyond the safety risks, the policy of enforcement discretion will give these unapproved peptide products the appearance of government sanction, leading consumers to believe that these substances are regulated and legal. This will be reinforced when the compounded peptides arrive in pharmacy-labeled vials, with a prescription from a licensed pharmacy, looking exactly like the more than 100 FDA-approved peptide medicines, including insulin and GLP-1 drugs, that have earned their place through large-scale clinical trials. A patient picking up a compounded BPC-157 injection will have no visible signal that it was never tested for safety, proper dosing, or long-term side effects. Just as deceptive advertising has left consumers confused about the difference between FDA-approved GLP-1 medicines and compounded copies, this policy would erase the line between proven medicines and experimental substances.
Moreover, NCL joins with numerous patient safety, medical and public health organizations in cautioning that FDA’s interim access policy will entrench an already dangerous market promoting “research-grade” peptides where influencers, podcasters, med spas, wellness clinics, and telehealth platforms promote these substances with sweeping claims about muscle repair, injury recovery, anti-aging, weight loss, and brain performance — assertions that are not supported by scientific evidence. Underscoring this concern, research published June 15, 2026, in the Journal of the American Medical Association finds over 130,000 Instagram posts and over 230 million views on TikTok as of May 2025 promoting synthetic peptides for muscle growth, injury recovery, anti-aging, and cognitive enhancement.
Because the interim policy implies regulation when none exists, consumers will be exposed to and will buy peptides that are unapproved, untested and exist outside of every lawful pathway believing the claims that these substances are “legal,” “pharmacy-grade,” and “doctor-prescribed” when these products are not backed by clinical trials and the FDA-approval process. Thus, consumers will be playing Russian Roulette with their health while FDA acts against its own mission of ensuring drugs are safe based on a regulatory system that requires rigorous pre-approval testing and FDA review, are of high quality based on good manufacturing practices and FDA inspections, and monitored for adverse events once they are on the market.
Recognizing what is at stake for the health of Americans, NCL supports the petition filed by the Partnership for Safe Medicines (PSM), which calls on the FDA to refrain from allowing compounding pharmacies to make and sell peptides that do not meet the conditions necessary to be included in the 503A Bulks List, the list of ingredients that compounders are permitted to use.
Current laws exist so that patients can trust they are getting safe, proven, and tested therapies. NCL therefore urges the FDA to follow its own scientists, reject a shortcut that bypasses the evidence, and require any peptide seeking broader access to go through full rulemaking with genuine scientific scrutiny. Consumers deserve the truth about what they are injecting, and they deserve a regulatory system that protects them rather than one that lends credibility to unsupported health claims.
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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.












