Consumer groups say HHS peptide policy puts patients at risk

Citizen petition urged FDA to reject July panel recommendation

Several consumer advocacy groups said the new federal policy on six peptides puts patients at risk. The nonprofit Public Citizen noted that Health Secretary Robert F. Kennedy Jr. seems to have acted unilaterally rather than through the typical rulemaking process.

Robert Steinbrook, Health Research Group Director at Public Citizen, wrote in a statement: “By allowing unproven and potentially unsafe peptides to be manufactured, marketed and prescribed without concern about potential federal enforcement actions, Kennedy has undermined the FDA and threatened public health.” He wrote: “All peptide substances should go through the standard FDA approval process for new drugs. The HHS Secretary should support, not sabotage, needed FDA enforcement actions to protect consumers.” Steinbrook advised clinicians to talk to their patients and tell them about the risk of contamination and other adverse effects.

The Partnership for Safe Medicines, which includes various pharmacy and pharmacist organizations around the country, filed a citizen petition last week urging the FDA to ignore the recommendation from its advisory committee in July to allow compounding pharmacies to make the six peptides. Its executive director, Shabbir Safda, wrote in a statement: “Today’s decision leaves Americans in a grey area as to whether peptides are safe or not, even though the FDA’s own scientists recommended against voting in favor of these substances due to concerns with evidence.”

The criticism responds to unproven but popular peptides touted for wellness that have been available on the gray market despite an official ban. HHS said in its new policy that it will exercise enforcement discretion for a half dozen peptides, essentially looking the other way when they’re made by small compounding pharmacies. The policy does not change the peptides’ legal status, but it creates a path for small compounders, called 503A compounding pharmacies. It does not apply to the larger ones, called 503Bs, that are outsourcing facilities producing higher volumes of medicines. Even though the peptides have not been through the FDA’s rigorous drug review and approval process, they could become easier to get.

Health Secretary Robert F. Kennedy Jr. has been a vocal supporter of peptides, saying he has used some of them himself. Peptides are strings of amino acids, shorter than proteins, that can exert powerful effects in the body; some occur naturally and others are synthetic variations. Wellness influencers and some clinicians have promoted unproven peptides for a wide range of uses, though the evidence for their safety and effectiveness is sparse. The policy says compounding is a safer alternative to illicit “research-use-only” peptides available online, which are often sourced from sketchy suppliers overseas.

The six peptides, and some of their unproven uses, are BPC-157 for ulcerative colitis, Epitalon for insomnia, KPV for wound healing, MOTS-c for metabolic health, Semax for migraine and TB-500 for wound healing.

In July, a panel of advisers to the FDA voted in favor of expanded access to the six peptides through compounding pharmacies. At the same meeting, the FDA’s own scientists recommended against unwinding the existing restrictions on them.

The policy’s focus on smaller producers may mean that pharmacists will have a tough time meeting demand. Joshua Fritzler, the president of Olympia and Wesley Pharmaceuticals in central Florida, said people have been asking about these peptides for years, but because they were illegal to compound, his company did not make them. Under the policy, only the company’s smaller compounding facility can make the peptides, and only in small quantities, he said. “We won’t be able to meet demand,” Fritzler said, explaining that Olympia will likely only compound one of the six peptides and needs to get its facility ready first. “I don’t think all the [503]As in the country could meet the demand.”

The Alliance for Pharmacy Compounding’s CEO, Scott Brunner, wrote in a statement that his group is pleased with the administration’s decision to allow the peptides to be compounded, because it offers a “more accountable alternative” for patients seeking gray-market peptides. “It also brings patients into a system where pharmacy standards, regulatory oversight, and serious adverse event reporting apply,” he said. Brunner warned, however, that it may take some time for compounding pharmacies to begin dispensing these products to patients, because ingredient suppliers need to make sure their active ingredients meet the policy’s requirements — and pharmacies need to verify that, too.

Public Citizen’s statements and the Partnership for Safe Medicines’ petition contest the policy’s safety basis as 503A facilities prepare to compound the six peptides. For now, access depends as well on ingredient suppliers meeting the policy’s requirements and on pharmacies verifying those ingredients — steps Brunner said will take time.