Health and Human Services Secretary Robert F. Kennedy Jr. has supported broader access to peptides. A new policy will make it easier for small compounding pharmacies to make it. Heather Diehl/Getty Images hide title toggle title i Heather Diehl/Getty Images Unproven but popular peptides touted for wellness have been available on the gray market, despite an official ban. Now, the Department of Health and Human Services is looking to bring them out of the shadows. HHS said in a new policy that it will exercise its enforcement discretion on a half-dozen peptides, essentially turning a blind eye when they are made by small compounding pharmacies. Secretary of Health Robert F. Kennedy Jr. has been a strong supporter of peptides and has said he has used some of them himself. Peptides are chains of amino acids, shorter than proteins, that can exert powerful effects on the body. Some occur naturally and others are synthetic variations. Wellness influencers and some doctors have promoted unproven peptides for a wide range of uses, although evidence for their safety and effectiveness is scarce. So while these peptides haven’t gone through the Food and Drug Administration’s rigorous drug review and approval process, they might be easier to obtain. But the policy’s focus on smaller producers may mean pharmacists will find it difficult to meet demand. In July, an FDA advisory panel voted to expand access to six peptides through compounding pharmacies. However, at the same meeting, the FDA’s own scientists recommended not removing the existing restrictions on them. The new policy says the compound is a safer alternative to illicit “research use only” peptides that are available online. They often come from dubious foreign suppliers. The peptides, and some of their unproven uses, are: BPC-157, ulcerative colitis, Epitalon, KPV insomnia, MOTS-c wound healing, Semax metabolic health, TB-500 migraine, wound healing Joshua Fritzler, president of Olympia and Wesley Pharmaceuticals in central Florida, says people have been asking about these peptides for years. But since it was illegal to make them, his company did not manufacture them. The new policy does not change their legal status, but it does create a path for small compounding manufacturers, called 503A compounding pharmacies. It does not apply to larger ones, called 503Bs, which subcontract facilities that produce larger volumes of drugs. That’s why at Fritzler’s company, only its smallest compounding facility will be able to produce the peptides, and only in small quantities, he says. And that has implications for consumers. “We won’t be able to meet the demand,” he says, explaining that Olympia will probably only make one of the six peptides and needs to prepare its facilities first. “I don’t think all [503]As in the country, it could meet the demand.” Scott Brunner, CEO of the Alliance for Pharmacy Compounding, 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 responsible alternative” for patients seeking gray market peptides. “It also introduces patients to a system where pharmaceutical standards, regulatory oversight and reporting of serious adverse events are applied,” he says. Brunner cautioned, however, that it may take some time for compounding pharmacies start dispensing This is because ingredient suppliers must make sure their active ingredients meet the policy’s requirements, and pharmacies must verify that, too. However, several consumer advocacy groups say the policy puts patients at risk. Public Citizen, a nonprofit, noted that Kennedy appears to have acted unilaterally rather than through the typical rule-making process: “By allowing unproven peptides to be manufactured, marketed and prescribed. potentially unsafe products without concern for potential federal law enforcement actions, Kennedy has undermined the FDA and threatened the public. health,” Dr. Robert Steinbrook, director of Public Citizen’s health research group, wrote in a statement. “All peptide substances must go through the FDA’s standard approval process for new drugs. The HHS Secretary should support, not sabotage, necessary FDA actions to protect consumers.” Steinbrook advised doctors to talk to their patients and inform them about the risk of contamination and other adverse effects. The Partnership for Safe Medications, which includes several pharmacies and pharmacist organizations across the country, filed a citizen petition last week, urging the FDA to ignore its advisory committee’s recommendation in July to allow compounding pharmacies to produce the six peptides. “Today’s decision leaves Americans in a gray area as to whether or not peptides are safe, even though the FDA’s own scientists recommended against voting in favor of these substances due to concerns with the evidence,” its executive director Shabbir Safda wrote in a statement.
