February 10, 2026
The first article of this series argued that the peptide boom is not just a fringe fad but a parallel ecosystem, built by people who feel conventional medicine is too slow, too narrow, or too inaccessible for the goals they care about. In our second article, we asked how far bodily autonomy should extend when competent adults deliberately choose to run experiments on themselves. This final article looks at how the current regulatory and economic systems were never structured or designed for this category of interventions, leaving peptides with no clear home, while also sketching out practical ways they might adapt to provide safer, more transparent options.
Drug regulation in high‑income countries is optimized for a specific problem: approving therapies that diagnose, cure, mitigate, or prevent recognized diseases. Evidence standards are built around hard clinical endpoints, such as mortality, hospitalization, or disease‑progression markers. This totally makes sense for cancer drugs, antibiotics, heart‑failure treatments and drugs targeting rare diseases [1].
Even GLP-1 agonist peptides were first approved as treatments for diabetes, and only later found a path into weight loss once obesity was classified as a “chronic disease”. But many peptides don’t fit neatly in any standard disease categories. They are often used for things like recovery, tissue repair, performance, or “healthy aging”, which makes them an awkward fit for traditional disease-centric approval processes.
The FDA has limited pathways for such interventions. “Wellness products” aren’t regulated as drugs, but only if they meet strict criteria: they must be low-risk, non-invasive devices or software that “maintain or encourage a healthy lifestyle” and be without claims of diagnosing, treating or preventing disease. Peptides seemingly fit this category, but because most peptides are delivered via an injection, and/or have biological activity they don’t meet the “non-invasive and low risk” requirements. Health Canada’s core logic is very similar to FDA’s where, despite not being explicitly stated in their regulations, anything injectable is considered higher risk and therefore falls under Therapeutic Products regulatory processes, rather than the Natural Health Product system.
This creates a regulatory catch-22 where many unpatentable peptides can’t navigate drug approval pathways (they don’t treat specific diseases) but also don’t qualify as wellness products either. They exist in a no-man’s land.
For a time, compounding pharmacies offered a partial workaround. Under section 503A and 503B of the U.S. Food, Drug, and Cosmetic Act, they can prepare custom medications for individual patients when certain conditions are met, without going through full approval. This pathway has long been used to tailor doses, formulations, and combinations for patients whose needs are not met by mass‑market products.
Peptides became a flashpoint here as well. As peptide use expanded, FDA began placing many peptides on its “bulks list” as Category 2 substances, indicating that their use in compounding “may present significant safety risks.” Once a substance is placed in that category, 503A and 503B pharmacies cannot dispense it, even with a physician prescription. Clinics and pharmacies that tried to continue offering compounded peptides faced warning letters and, in some cases, legal challenges.
From a safety perspective, concerns are understandable: variable purity, potential contamination, and unknown long‑term effects are genuine issues. The effect for users was to remove a supervised channel and push them toward gray‑market suppliers and self‑sourced protocols. Unfortunately, these are the very environments where quality control and monitoring are weakest.
Regulatory systems worldwide are designed around a dual foundation that focuses on disease-treatment paradigms that require time-consuming and expensive clinical validation. Bringing a compound from concept to approval typically costs hundreds of millions of dollars and takes 10–15 years. Companies need a way to recoup that investment, and that is what patents and FDA‑granted exclusivity periods are designed to achieve.
This model made sense when novel chemical compounds dominated drug discovery, but nature-inspired peptides face significant patent challenges. To qualify for patent protection, a peptide must be novel, non-obvious, and demonstrate utility. If a peptide too closely resembles naturally occurring sequences, patent offices may deem it to be obvious or derivative [2]. Modifications and delivery systems can sometimes be patented, but simple, nature-inspired peptides are harder to defend. It is estimated that 50% of historically approved drugs would be deemed unpatentable under the Supreme Court’s more recent Myriad and Mayo decision .
Natural products show 6-to-8-fold lower patent application rates than synthetics [3]. This results in compounds with promising preclinical evidence to remain undeveloped, not because they’re unsafe or ineffective, but because they’re unprofitable under current intellectual property frameworks [4]. This limitation doesn’t just apply to peptides, similar issues have been noted in the development of cancer therapeutics [5].
Moreover, peptides face unique development hurdles: short half-lives requiring frequent dosing, poor oral bioavailability necessitating injection, potential immunogenic responses, and complex dose-response relationships [4, 6, 7]. Each factor increases costs and regulatory complexity, further deterring investment. Without patent exclusivity to recoup costs, it is financially infeasible to fund the $800+ million trial-to-FDA approval process.
However, regulators cannot lower safety and efficacy thresholds just because a compound is hard to patent. Their mandate is to protect the public, not to guarantee a return on investment. The result is that some peptides with promising preclinical data and limited early human experience, such as BPC‑157, remain stuck: not approved, not heavily studied, and not formally available for human use.
None of this implies that peptides should be deregulated, or that safety concerns are overstated. Immunogenicity, off‑target effects, impurities, and unknown long‑term risks are all important reasons for caution. But do we need to choose between full approval and complete prohibition? A more adaptive regulatory approach might include:
These are system‑level design questions, not indictments of any particular actor. Pharmaceutical companies, regulators, clinicians, and patients all live and operate within incentive structures they did not create. The peptide boom is making those structures visible by highlighting what happens when there is demand for a class of compounds that current models cannot easily accommodate.
Our first article in this series showed how people are building their own parallel evidence systems, and the second article argued that autonomy means more than just the freedom to say no. In this article, we suggest that our institutions have a choice to either continue to treat peptides primarily as a problem (further driving an underground market) or consider making them a test case for more flexible, learning‑oriented frameworks that incorporate both safety and human agency. In the long run, the real story may be less about peptides themselves and more about whether our systems are willing to evolve as an increasingly educated public demands more flexibility from its regulatory institutions.
References
[1] E. E. Kepplinger, “FDA’s Expedited Approval Mechanisms for New Drug Products.,” Biotechnol. law Rep., vol. 34, no. 1, pp. 15–37, Feb. 2015, doi: 10.1089/blr.2015.9999.
[2] B. N. Roin, “Unpatentable Drugs and the Standards of Patentability,” Tex. Law Rev., vol. 87, pp. 503–570, 2009, [Online]. Available: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1127742
[3] D. Domingo-Fernández et al., “Natural Products Have Increased Rates of Clinical Trial Success throughout the Drug Development Process.,” J. Nat. Prod., vol. 87, no. 7, pp. 1844–1851, Jul. 2024, doi: 10.1021/acs.jnatprod.4c00581.
[4] W. Xiao et al., “Advance in peptide-based drug development: delivery platforms, therapeutics and vaccines,” Signal Transduct. Target. Ther., vol. 10, no. 1, p. 74, 2025, doi: 10.1038/s41392-024-02107-5.
[5] D. Ovcharenko, D. Mukhin, and G. Ovcharenko, “Alternative Cancer Therapeutics: Unpatentable Compounds and Their Potential in Oncology,” 2024. doi: 10.3390/pharmaceutics16091237.
[6] C. Säll et al., “Industry Perspective on Therapeutic Peptide Drug–Drug Interaction Assessments During Drug Development: A European Federation of Pharmaceutical Industries and Associations White Paper,” Clin. Pharmacol. Ther., vol. 113, no. 6, pp. 1199–1216, Jun. 2023, doi: 10.1002/cpt.2847.
[7] M. Liu et al., “Progress in peptide and protein therapeutics: Challenges and strategies,” Acta Pharm. Sin. B, vol. 15, no. 12, pp. 6342–6381, 2025, doi: 10.1016/j.apsb.2025.10.026.