Zachary Shurtleff, marketing manager for a wellness-focused compounding pharmacy, also celebrated, writing, “Peptides are BACK like they were never supposed to leave!
Lee Rosebush, president of the American Academy of Peptide Medicine, a group formed last year, issued a statement thanking Kennedy and the Trump administration for “taking a forward-thinking, evidence-based approach to peptide regulation.”
Critics have pushed back, noting that there are already reports of harm from peptides.
In a statement released Tuesday, ahead of the new rule’s release, the Center for Science in the Public Interest outlined several reasons why making unproven peptides more accessible is dangerous. On the one hand, reports of harm “will continue to increase,” the CSPI said. And if one of the peptides actually showed promise of effectiveness, reputable pharmaceutical companies would have less incentive to pursue extensive clinical trials if the peptide was already widely available. Additionally, allowing access to peptides based on commercial demand could open the door to other unapproved products, creating an incentive for illegal sales.
Fred Mills, policy director of Americans for Safe and Effective Medicines (ASEM), said in a statement Wednesday that the new rule “does not address issues related to untested products, safety risks, questionable ingredients, or misleading claims. In fact, we believe it will worsen what we have already seen: the harms of mass compounding that hit communities hard due to a lack of oversight to rein in bad actors. We must follow the science, and the reality is that the FDA itself has continued to sound the alarm about lackluster drug data. peptides. Safety and efficiency are not trump cards; they are necessary.
Gn bussni
