Under Health Secretary Robert F. Kennedy Jr., the Food and Drug Administration is moving forward with plans to ease access to unproven peptide drugs that are popular among members of Kennedy’s Make America Healthy Again movement—despite FDA staff scientists finding that the drugs have not been sufficiently studied to establish safety and efficacy and may cause harms.

The FDA submitted an “Interim Access Policy” on peptides for review by the White House, according to a filing notice posted on an Office of Management and Budget website. The posting does not provide information on the proposed policy. But people familiar with the proposal told The Associated Press that it would give the FDA “enforcement discretion” on certain peptide drugs. This would allow the agency to choose not to enforce current restrictions on peptides and provide an assurance to specialty pharmacies eager to start making them that they will not be targeted by the agency.

The proposal comes as the FDA is currently re-reviewing a dozen popular, but unproven, injectable peptide drugs. In 2023, FDA scientists determined that the peptides lacked data on safety and efficacy and posed risks. As such, they were stricken from a list of drugs that can be made by specialty pharmacies, called compounding pharmacies, which make customized formulas for drugs.

“Charlatans”

Still, the dodgy drugs have grown more popular, with sellers claiming, without evidence, that the drugs can improve appearance, boost energy, and help heal injuries, among other wellness claims. They’re especially popular among the MAHA crowd; many prominent MAHA figures sell peptide products, and Kennedy, a self-proclaimed “big fan” of peptides, vowed to end “FDA’s war” on peptides upon taking office.

In April, the FDA announced that it would reconsider 12 unproven peptides. In June, Kennedy appointed nine new members to a 13-member FDA advisory panel that would review the peptides. Of the new members, at least six have ties to peptide-related businesses and clinics, raising significant conflict-of-interest concerns. In a July meeting, the panel voted to recommend adding six of the first seven peptides considered back to the list of drugs compounding pharmacies can make. The recommendations overruled FDA staff scientists who maintained that the drugs still lack data on safety and efficacy and posed risks.

It’s unclear if the FDA will follow through with the recommendation. The AP notes that formally adding the peptides back to the compounding list involves a federal rulemaking process that could take years and require multiple rounds of public comment. The new proposed enforcement discretion could ease access in lieu of that rulemaking or provide access during the process.

Science-based advocacy group the Center for Science in the Public Interest (CSPI) is among those strongly pushing back on Kennedy’s efforts to support unproven peptides. The group sent a letter to Acting Food and Drug Administration Commissioner Kyle Diamantas this week, urging him to disregard the panel’s recommendations.

“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,” Pete Lurie, CSPI president and a former associate commissioner at the FDA, said in a statement.