HHS Grants Access to Six Peptides Despite FDA Opposition
The Department of Health and Human Services (HHS) announced Wednesday a new policy that will allow compounding pharmacies to produce and sell six injectable peptides—BPC-157, TB-500, Epitalon, KPV, MOTS-c, and Semax—without FDA enforcement action, even though none have been approved as safe and effective. The policy, titled “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances,” was posted on the Federal Register and is set for final publication on October 30.
According to sources familiar with the policy’s development, the move was driven almost entirely by HHS and faced overwhelming pushback from FDA drug staffers, who warned it could undermine the agency’s mission of keeping unproven products off the market. The policy directs the FDA not to take action against specialty pharmacies that sell the peptides, which would otherwise be considered illegal drugs because they have not undergone the agency’s rigorous review process for safety and effectiveness.
What the Policy Does—and Doesn’t Do
The policy does not grant FDA approval or establish clinical safety and effectiveness. Instead, it requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting. HHS argues this will improve safety by providing an alternative to black-market sellers. “Under President Trump’s leadership, HHS is working to put prevention and patient safety at the center of health care—and that includes confronting the risks of black-market peptides,” an HHS statement said.
Background: A Controversial Push from the Top
The peptides in question have been promoted online for building muscle, healing injuries, boosting energy, and longevity, but there are no published clinical trials demonstrating their effectiveness in humans for any condition. In 2023, the FDA removed the six peptides from a list of drugs that compounding pharmacies can make, citing safety concerns. HHS Secretary Robert F. Kennedy Jr., who has called himself a “big fan” of peptides and recently described using BPC-157 to treat a muscle injury, had proposed the rule earlier this month.
Kennedy’s rationale for the policy includes a July vote by an FDA advisory committee to recommend adding the peptides back to the compounding list. However, prior to the vote, Kennedy stacked the 12-member committee with eight new members, at least six of whom have ties to peptide-related businesses and clinics, raising conflict-of-interest concerns. Kennedy also argues that safety concerns are mainly hypothetical, but this is largely because there are few to no human studies showing either benefits or harms.
FDA Scientists Sidelined
According to six people who spoke to the Associated Press on condition of anonymity, most FDA scientific staff members opposed the plan and had limited input in drafting it. They warned that easing access could undermine the agency’s longstanding mission. HHS officials initially wanted the FDA to draft an official regulation adding the peptides to the compounding list, but FDA officials warned that their scientific staff had major safety concerns and would not support such a regulation.
Perspective: A Broader Shift in Health Policy
The move reflects a broader trend under the Trump administration of prioritizing deregulation and consumer choice in health care, often overruling career scientists. It also highlights the growing influence of the MAHA (Make America Health Again) movement, which has championed peptides as wellness tools despite limited evidence. Critics argue that the policy could expose patients to unnecessary risks, as unregulated products may be contaminated or inaccurately dosed. Doctors warn that without clinical trials, patients cannot know whether the peptides are safe or effective.
The policy also raises questions about the integrity of the FDA’s advisory process, given the reported conflicts of interest among newly appointed committee members. As peptide peddlers cheer the decision, the long-term impact on public health and regulatory oversight remains uncertain.
What’s Next
The policy is set to take effect following its publication on October 30. It remains to be seen whether legal challenges or congressional scrutiny will follow. For now, patients with prescriptions will have access to the peptides through compounding pharmacies, while the FDA’s traditional role in reviewing drug safety and efficacy appears to have been bypassed.
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