Media Contact: Lisa McDonald, Vice President of Communications, 202-207-2829 

Washington, DC – As an organization focused on the safety of GLP-1 weight loss drugs, the National Consumers League welcomes the August 27 ruling by the US Court of Appeals for the Fifth Circuit affirming the Food and Drug Administration’s (FDA) decision to remove the popular GLP-1 weight loss drug semaglutide from its drug shortage list as lawful and correct.

The Court’s decision, which also applies to the FDA’s action removing tirzepatide from the shortage list, is especially important because it validates the legal framework for how the FDA regulates the sale of compounded drugs during shortage situations. Dating back to the passage of the Food and Drug Administration Modernization Act in 1977, this framework both allows compounders to produce temporary versions of commercially available drugs during shortages, but it also makes it illegal for the continued mass production and sale of compounded versions when the shortage has ended.

Yet, despite being in existence for almost 50 years, the framework for removing drugs from the shortage list was recently challenged, not because there are legal issues, but because the mass-marketing of compounded GLP-1s became big business for compounding pharmacies and direct-to-consumer telehealth platforms while the branded GLP-1 weight loss drugs were in short supply. In fact, in 2024, compounded versions accounted for an estimated 30% of the overall GLP-1 weight-loss market. Thus, the Outsourcing Facilities Association (OFA), an organization representing compounding pharmacies, sued the FDA for declaring an end to the shortages of semaglutide and tirzepatide, claiming the agency was “abruptly depriving patients of much needed treatment and artificially raising drug prices.”

Among OFA’s arguments were that the FDA ignored evidence that the shortages continued to exist, and that the agency did not give compounders reasonable notice of the planned determinations or allow them to weigh in with comments. But here is the good news: the Appeals Court reviewed the evidence and rejected these arguments, concluding that the FDA “followed the statutory framework, applying the statutory definition of shortage to the evidence before it.”

Importantly, the Court also endorsed FDA’s methodology and its reliance on actual supply data from the manufacturers to make the determination of the end of the shortage. Specifically, the Court declared that pharmacy screenshots, patient reports, articles, blog posts, and form letters submitted by compounders are less probative than “more specific, reliable, comprehensive, and current” data from the manufacturer – codifying common sense and the value of verifiable evidence.

At a time of growing concern over the need to improve the regulation of compounded drugs and restore compounding to its intended purpose, the Fifth Circuit’s ruling represents a line in the sand for policymakers and compounders. FDA’s time-tested regulatory framework for addressing shortage situations works and relies on a thorough review of the evidence that credits specific, reliable, comprehensive, and current information and data—up and down the product supply chain—over anecdotal, isolated, and unreliable reports.

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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.   

Media Contact: Lisa McDonald, Vice President of Communications, 202-207-2829

Washington, DC – At a time when a Food and Drug Administration advisory committee recommends loosening restrictions on some widely promoted research-grade peptides, the National Consumers League is going public about the serious health consequences of acquiring and self-injecting peptides that have not been proven through completed clinical trials to be safe and are prohibited for human use in Canada, Australia, the European Union, and by the World Anti-Doping Agency.

Peptides, defined as short strings of amino acids, are the fundamental building blocks of proteins naturally produced in the body and act as cellular messengers to regulate functions like metabolism, tissue repair, hormone production and immune responses. To date, the FDA has approved more than 100 peptide-based drugs, including insulin and GLP-1 medications, to treat conditions ranging from diabetes and metabolic disorders, to osteoporosis, multiple myeloma, and severe chronic pain, based on large-scale human clinical trials demonstrating their safety and effectiveness.

However, today a new threat has emerged. Thousands of consumers are going to an underground market to buy unapproved, unregulated injectable “wellness” peptides directly from online storefronts, med-spas, and wellness clinics without understanding that these peptides are not intended for human use, and without knowing of an FDA warning that these peptides “have not been found safe and effective for any condition.” Moreover, consumers may be buying fake or underground retatrutide, a potent weight loss drug currently undergoing clinical trials and not yet FDA-approved. These counterfeit versions of retatrutide could lead to accidental overdoses and severe adverse events.

What makes this gray market so dangerous is the ease with which consumers can buy unapproved peptides outside of regulatory controls. In this market, consumers often learn about “wellness” peptides through social media platforms, Reddit threads, and podcasts where social media influencers, athletes, celebrities, and do-it-yourself biohackers promote these substances for muscle growth, injury recovery, anti-aging, and cognitive enhancement.

This includes wellness peptides that the FDA advisory committee recommends adding to a list of substances that compounding pharmacies can use to make products to sell to consumers, such as BPC-157 and TB-500 for tissue repair and muscle building and MOTS-c for metabolic enhancement and longevity. Also in this category are growth hormone-releasing peptides, including Sermorelin, CJC-1295, and Ipamorelin, for restorative sleep and daytime energy. Not on the list is retatrutide, which is going through a formal FDA approval process, unlike the wellness peptides, where the FDA will review extensive data from many human clinical trials to determine whether retatrutide is safe and effective for clinical use.

According to global health experts, none of the wellness peptides are backed by sufficient scientific evidence to support their safety and effectiveness.  Yet due to the massive hype surrounding synthetic peptides, consumers who believe the claims go online to buy peptides labeled “for research use only,” which is a way for gray market vendors to sidestep drug safety regulations. Moreover, online vendors with website storefronts use slang, such as “pep” for peptide, to announce what they are selling through informal online channels, such as chat rooms and social media platforms. On these same online marketplaces, users rely on social media tutorials and influencers for advice on how to self-administer peptides, which are supplied as powders or injections in poorly labeled or unmarked vials.

There are serious consequences when consumers self-inject unapproved peptide products. Because many popular injectable wellness peptides are not approved or formally regulated by the FDA, there is sparse evidence to verify the safety and efficacy of these substances. Additionally, unapproved peptides are manufactured mostly in facilities in China and India where quality standards vary, and the peptides may go uninspected, leaving consumers with no assurance of their sterility, potency, purity, dosing consistency, or ingredient authenticity.

Therefore, NCL urges consumers to learn about the safety risks associated with taking unapproved experimental peptides and heed these warnings from the American Medical Association (AMA) and many global bodies:

• Peptides labeled for “research use only” are not intended for human consumption. The label is a requirement for vendors to sell to researchers for testing purposes and indicates that the peptide is not FDA-approved and may not be safe.
• Most experimental peptides are not backed by scientific evidence demonstrating they are safe and effective. According to a recent FDA analysis, the research to date on the safety of wellness peptides mostly involves small animal studies or in vitro experiments. Even when there are human studies, they often do not evaluate different routes of administration, dosage levels, and the potential side effects.
• The source of synthetic peptides is a safety concern. US Customs records show that imports of hormone and peptide compounds from China nearly doubled in 2025, and now, China-based chemical companies that produce fentanyl precursors are selling peptides online. These facilities operate without third-party testing, batch-specific certificates of analysis, or analytical verification, which present significant safety implications.
• Peptide products may be of poor quality and contain harmful contaminants. Unapproved peptides manufactured without adequate quality controls often contain impurities, incorrect doses, or contaminants, such as heavy metal traces (like arsenic) and bacterial endotoxins. Accordingly, a Health Canada alert warns that experimental peptides can cause harmful contaminants to be injected directly into the bloodstream, serious dosing errors, hormonal and blood sugar imbalance, and liver and kidney damage.
• Unapproved peptide products, particularly those that are injected, carry significant safety risks. Australia’s Therapeutic Goods Agency cites reports of serious adverse effects from injecting research-grade peptides resulting in inflammation and liver damage. Similarly, the AMA issued a warning that some injectable peptides can trigger abnormal immune system responses, leading to allergic reactions (including severe ones like anaphylaxis) or autoimmune issues in some people.
• Knockoff retatrutide products are counterfeit and can be dangerous.

Because retatrutide has not completed the FDA approval process, products sold online or through clinics are black market drugs and come with no guarantee of quality, purity, or dosing accuracy. Consequently, so-called retatrutide sold through the underground market may contain substituted chemicals, toxic impurities, or completely different active compounds instead of true peptide. Already, CBS News found that health problems reported to America’s Poison Centers about retatrutide surged to an average of 95 cases per month in early 2026, a 265% increase from late 2025. Also of great concern, in January 2026, health authorities in Australia issued an urgent alert after multiple users of black-market retatrutide suffered from acute liver failure, major kidney injuries, and life-threatening changes in heart rate.

Claims that wellness peptides aid in muscle repair, inflammation reduction, and injury recovery are not supported by scientific evidence. The World Anti-Doping Agency (WADA) put BPC-157, TB-500, and MOTS-c on its Prohibited List, banning these substances in athletic competition because there is insufficient data to confirm their safety.

In light of these facts, NCL urges consumers to follow the advice of the AMA and global health bodies, all of which urge consumers not to self-inject research-grade synthetic peptides due to the serious safety risks associated with these peptides, including severe immune reactions and possible organ damage.

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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.