Zachary Shurtleff, a marketing executive for a wellness-focused compounding pharmacy, also celebrated, writing, ” Peptides are BACK like they never shoulda left!”
Lee Rosebush, chair of the American Academy of Peptide Medicine, a group formed last year, released a statement thanking Kennedy and the Trump administration for “taking a forward-thinking, evidence-based approach to the regulation of peptides.”
Critics have pushed back, noting that there are already reports of harms from peptides.
In a statement released Tuesday, before the new rule was released, the Center for Science in the Public Interest laid out several reasons why making unproven peptides more accessible is dangerous. For one, reports of harms will “continue to mount,” CSPI said. And if any of the peptides actually showed promise of efficacy, reputable pharmaceutical companies will have less incentive to follow up with thorough clinical trials if the peptide is already widely available. Further, allowing access to peptides based on marketing demand could open the doors for other unapproved products, creating an incentive for illegal sales.
Fred Mills, chief policy officer of Americans for Safe and Effective Medicines (ASEM), said in a statement Wednesday that the new rule “does not resolve problems with untested products, safety risks, questionable ingredients, or misleading claims. In fact, we believe this will worsen what we have already seen—the harms from mass compounding hitting communities hard due to a lack of oversight to rein in bad actors. We need to follow the science, and the reality is that FDA itself has continued to sound the alarm on lackluster data on these peptides. Safety and efficacy aren’t a nice-to-have; they are required.”
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