Kennedy's FDA backs off peptide rules

Under Health Secretary Robert F. Kennedy Jr., the FDA is proposing enforcement discretion on unproven peptide drugs popular among his Make America Healthy Again supporters.

What enforcement discretion means

The proposal would allow the FDA to choose not to enforce current restrictions on peptides, giving specialty pharmacies assurance they will not be targeted by the agency.

Scientists say peptides are unsafe

In two thousand twenty-three, FDA scientists determined that peptides lacked data on safety and efficacy and posed risks. They were removed from a list of drugs compounding pharmacies can make.

Kennedy stacks the review panel

In June, Kennedy appointed nine new members to a thirteen-member FDA advisory panel reviewing peptides. At least six have ties to peptide-related businesses, raising conflict-of-interest concerns.

Panel votes to restore peptides

In July, the panel voted to recommend adding six of the first seven peptides back to the compounding list, overruling FDA staff scientists who maintained the drugs still lack safety data.

Advocates warn of consumer harm

The Center for Science in the Public Interest urged the FDA to disregard the panel's recommendations. Pete Lurie, CSPI president, said charlatans will put consumers at risk of serious injury.

“If this conflicted committee's recommendations stand, charlatans will continue to put unsuspecting consumers at risk of serious injury by making unsupported claims about their [peptides'] purported benefits.”