A Shot in the Dark: The Future of Peptide Regulation

By Emma Brownstein.

What are Peptides?

Peptides are short chains of amino acids that occur naturally in humans and function as signaling molecules in the body. They help regulate biological processes such as metabolic activity, muscle growth, and hormone regulation. Peptides are also found in foods such as meat, soy, and oats. Synthetic peptides artificially created in a lab have recently gained popularity for producing heightened targeted physiological effects based on a consumer’s desired outcomes.

Currently, many peptides are used in medicine. More than 100 peptide drugs have received approval from the U.S. Food and Drug Administration (FDA), including GLP-1 medications like Ozempic and Wegovy that treat Type 2 diabetes and obesity. As the demand for these drugs continues to grow, the global peptide market is projected to hit nearly $100 billion by 2035. 

Yet, alongside this legitimate pharmaceutical market, a new commercial market has emerged: unapproved peptides. Vendors market these products through online retailers, medical spas, supplement shops, and social media influencers for purposes ranging from weight loss and skin rejuvenation to muscle growth and even tanning. Unlike FDA-approved medications, these products often reach consumers without undergoing routine safety measures.

As this market continues to grow, a legal question is raised: to what extent should the government regulate the commercial sale and marketing of peptides, particularly when consumers may not understand their potential risks?

The Regulatory Landscape

The FDA approval process exists to ensure that drugs are safe and effective before they reach consumers. New drugs typically undergo lab research and multiple phases of human clinical trials before manufacturers can submit an application for FDA approval. This process can take anywhere from ten to fifteen years and millions, sometimes billions, of dollars. 

Ozempic illustrates the extent of this review process. Before receiving FDA approval, the drug underwent years of clinical development and human trials involving more than 10,000 participants, followed by a ten-month FDA review before approval. 

Many peptide vendors seek to avoid this regulatory process altogether. Instead of seeking FDA approval, grey market companies market peptides online under the label “Research Use Only” (“RUO”). By labeling products as intended only for lab research, sellers attempt to avoid the legal consequences associated with marketing unapproved drugs for human use. Despite these RUO disclaimers, the FDA has repeatedly concluded that when a company’s marketing shows that consumers are expected to use the products for human consumption, the product may still violate federal law. 

Peptide suppliers also attempt to establish credibility among consumers by showcasing third-party Certificate of Analysis (“CoA”) verifications on their website, which are intended to verify a product contains the advertised compounds and meets specific purity standards. Independent lab testing can promote consumer confidence, but these certifications are only valuable if they are authentic. For example, in July 2026, the founder of Paradigm Peptide, a peptide vendor who made over $5 million in sales, was sentenced to federal prison after admitting that he forged lab certifications while selling illegally imported peptides to over 54,000 customers. Consumers who believed they were purchasing independently verified products instead received substances that had never undergone quality testing, and some users even reported adverse health effects.

Although consumers may believe they are purchasing safe products, the absence of sufficient regulation allows deceptive marketing practices and forged certifications to reach consumers. 

Authority to Regulate

Both state and federal governments have the constitutional authority to regulate the peptide market. 

State governments hold broad authority under their inherent police powers to protect the health, safety, and welfare of their residents. While the federal government’s authority is limited to powers enumerated in the U.S. Constitution, states retain a general police power. The Tenth Amendment does not create this power, but it recognizes that powers not delegated to the federal government remain with the states. The Supreme Court in Jacobson v. Massachusetts recognized this power, explaining that states may enact reasonable regulations to protect public health and safety. States have long exercised their police powers by regulating pharmaceuticals and other substances. One way states regulate is by requiring pharmacies to report controlled-substance prescriptions to Prescription Drug Monitoring Programs, and by imposing limits on opioid prescribing to improve patient safety. 

The federal government also possesses authority under the Commerce Clause in Article I, Section 8 of the Constitution. This power authorizes Congress to regulate interstate commerce. Because peptide sellers commonly distribute and advertise products across state lines through online marketplaces, Congress arguably has the authority to regulate their manufacturing, marketing, and distribution. Federal statutes like the Controlled Substances Act already regulate numerous drugs and chemicals under the Commerce Clause. 

Therefore, both state and federal governments have substantial authority to regulate in this area. But, another question is posed: what should regulation look like?

A Proposed Approach

Rather than prohibiting peptide products, lawmakers could adopt regulatory tools already used for pharmaceuticals to improve consumer safety while maintaining access to lawful peptide innovation. 

At the state level, legislatures could require peptide sellers to obtain licenses, use accredited third-party labs to verify product purity, accurately label ingredients, and refrain from making baseless health claims. Civil or criminal penalties on businesses that knowingly market products without having these protections in place could also be implemented. 

At the federal level, Congress could authorize the FDA to establish a pathway program specifically for commercially marketed online peptide sellers, rather than trying to force peptides into the categories of approved or unregulated drugs. This could require setting minimum standards for quality, product testing, and truthful advertising before selling products intended for human use. 

Although this proposal would strengthen consumer protections, its implementation may face political obstacles. Recent federal policy has moved toward loosening restrictions on certain peptides by reclassifying several compounds, despite lack of human safety data. Regardless, those policy shifts do not reduce the need for consumer protections. As the peptide market expands, policies emphasizing transparency and product quality would better protect public health while preserving access to peptide innovation. 

The Debate

The debate over peptide regulation highlights the tension between individual liberty and public health. Supporters of limited regulation argue the government should not dictate what substances competent adults decide to place into their bodies. On the other hand, supporters of stricter regulation argue that meaningful consumer choice depends on accurate information. Consumers cannot provide informed consent when products are marketed with unsupported medical claims, false lab certifications, or misleading RUO labels. Under this view, government regulation ensures that consumers receive accurate information about products they may otherwise mistakenly believe will safely improve their health. 

The expansion of the peptide industry also shows that current regulatory frameworks have struggled to keep pace with rapid scientific innovations. This profitable market for unapproved peptides thrives on exploiting regulatory loopholes to reach consumers. Yet both state governments and federal governments possess the power to regulate these products. 

Research will continue to reveal the benefits and risks of unregulated peptides, and policymakers will eventually face pressure to create new regulatory frameworks surrounding the substances. Whether those future efforts can achieve the balance between consumer protection and individual autonomy remains an open question.