Supporters have welcomed new rules from President Kennedy and the Trump administration concerning peptides, but public-health and medication-safety advocates warn that expanding access to unproven products could increase patient harm, weaken incentives for clinical research, and encourage illegal sales.
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—also issued a statement thanking President Kennedy and the Trump administration for “taking a proactive, evidence-based approach to regulating peptides.”
Critics warn of safety risks
Critics have pointed to reported harms associated with peptides, arguing that wider access could expose more people to products whose safety and effectiveness have not been established.
In a statement released Tuesday, before the new rules were announced, the Center for Science in the Public Interest outlined several reasons it considers broader availability of unproven peptides dangerous.
“The number of reported incidents will continue to increase,” CSPI said. The organization also argued that even if a peptide showed promise, reputable drug companies would have less incentive to conduct thorough clinical trials if the product were already widely available.
CSPI further warned that granting access based on marketing demand could open the door to other unapproved products and create incentives for illegal sales.
Safety and effectiveness remain unresolved
Fred Mills, chief policy officer of ASEM, or 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.”
Mills also criticized the lack of strong data on these peptides, emphasizing that safety and effectiveness are essential requirements rather than optional benefits.
Source: arstechnica.com
