Supporters of the new rules making unproven peptides more available have praised the Trump administration’s approach, while public health and consumer safety groups warn that wider access could increase reported harms, weaken incentives for clinical research, and encourage misleading or illegal sales.
Supporters welcome the new rules
Zachary Shurtleff, marketing director for a wellness-focused compounding pharmacy, congratulated the administration, writing, “Peptides are back like they never left!”
Lee Rosebush, president of the American Academy of Peptide Medicine, an organization founded last year, issued a statement thanking President Kennedy and the Trump administration for “taking a proactive, evidence-based approach to regulating peptides.”
Critics warn of safety and oversight problems
Critics have pointed to reported harms from peptides as evidence of the risks involved.
In a statement released on Tuesday, before the new rules were announced, the Center for Science in the Public Interest outlined several reasons why making unproven peptides more widely available could be dangerous. The number of reported incidents, CSPI said, “will continue to increase.”
The organization also warned that even if one of the peptides eventually showed promise, reputable drug companies could have less incentive to conduct thorough clinical trials if the product were already widely available. Granting access based on marketing demand, CSPI added, could open the door to other unapproved products and create incentives for illegal sales.
Fred Mills, chief policy officer of ASEM (Americans for Safe and Effective Medicines), said in a statement Wednesday that the new rule “does not solve the problem of untested products, safety risks, questionable ingredients, or misleading labeling.”
“In fact, we believe this will exacerbate what we’ve already seen: mass compounding that takes a toll on communities due to a lack of oversight to rein in bad actors,” Mills said. “We need to follow the science, and the reality is that the FDA itself continues to sound the alarm. Lackluster data on these peptides is not enough. Safety and effectiveness are not nice-to-haves; they are necessary.”
Source: arstechnica.com