The Next Chapter for Peptides

Jeff Cohen says one of the biggest misconceptions is that peptide manufacturing is simple. He argues that buying a lyophilizer and sourcing API is not enough, as successful manufacturing requires expertise, experience, capital and robust quality systems. He believes the direct-to-consumer RUO marketplace, particularly vendors selling injectable GLPs, remains the part of the industry most exposed to regulatory enforcement. In his view, if RUO vendors had never sold GLPs, research-use-only products would likely have attracted far less attention. Modified Peptides and Intellectual Property When asked about modifying GLPs to avoid the “essentially a copy” issue, Cohen says the legal questions are largely matters of intellectual property. He notes that determining whether a modified peptide is sufficiently different requires specialist IP expertise and depends on both patent law and chemical structure. He says early attempts to differentiate products often involved adding ingredients such as vitamin B12 or glycine, but believes formulation science has become much more sophisticated. According to Cohen, the RUO sector is now a major area for peptide formulation and experimentation. Pharma’s Next Move Cohen believes pharmaceutical companies are already preparing to enter the longevity market, just as they have dominated the GLP market. He expects major companies to expand into longevity peptides over the next few years. He also predicts pharmaceutical companies will continue aggressively protecting retatrutide and considers this one of the most underestimated regulatory trends in the industry. Future Enforcement Cohen says direct-to-consumer businesses selling products that compete with pharmaceutical companies remain the most vulnerable to enforcement. Looking ahead, he expects increasing scrutiny of 503A compounding pharmacies, with greater emphasis on whether clinicians have adequately documented the clinical need for compounded products. Advice for Peptide Businesses Cohen says many businesses still fail to study FDA warning letters and pharmaceutical legal actions, despite these documents clearly identifying the website content regulators object to. His advice is to “measure twice and cut once,” encouraging businesses to regularly reassess regulatory developments rather than assuming yesterday’s understanding still applies. His Personal Wellness Routine Cohen says his current focus is follistatin, as maintaining muscle mass has become increasingly important with age. His current routine includes: Low-dose GLP microdosing. NAD. MOTS-c. SS-31. Semax/ Selank for cognitive support. Outside peptides, he says hormone optimisation, exercise and nutrition remain the foundations of his wellness approach, while spending time with his wife and growing family is his main priority outside work. A big thank you to Jeff for giving us this extremely informative interview