FDA Experts Resist White House Push to Deregulate Peptide Injections
FDA scientists are pushing back against a new HHS plan to ease access to unproven peptide drugs, citing significant safety concerns and regulatory risks.
POLICY WIRE — Washington, D.C. — A proposal championed by Health and Human Services Secretary Robert F. Kennedy Jr. to expand public access to unproven peptide drugs has encountered stiff resistance from the scientific staff at the Food and Drug Administration.
According to six individuals familiar with the internal policy development, FDA experts were largely sidelined during the drafting process and have warned that the initiative could compromise the agency’s core mandate to prevent unverified health products from entering the U.S. market.
The policy, which is currently undergoing final regulatory review at the White House, focuses on injectable peptides that have gained significant traction within the wellness industry. Under the proposed guidelines, the FDA would be directed to refrain from taking enforcement action against specialty pharmacies that distribute these substances, despite the fact that they have not undergone the agency’s standard safety and efficacy evaluations.
While some peptides are naturally occurring in the human body and are utilized in FDA-approved treatments for conditions like diabetes, the specific chemicals targeted by this policy—such as BPC-157 and TB-500—lack such rigorous vetting. These substances are frequently marketed for muscle building and injury recovery, and both are classified as doping agents by international sports governing bodies.
Secretary Kennedy has publicly expressed his support for these products, noting his own use of BPC-157 to address a muscle injury. He has argued that providing a legal pathway through compounding pharmacies is necessary to prevent Americans from relying on the gray market, where products are often imported from China.
The current proposal represents a shift from earlier HHS strategies. Initially, officials sought to have the FDA formally classify these peptides as safe for use in compounding pharmacies. However, after FDA scientists raised major safety objections, the administration pivoted to a directive that would simply instruct the agency to halt enforcement actions against pharmacies that produce them.
To mitigate potential risks, the final draft includes technical guardrails suggested by FDA staff, such as requiring pharmacies to source ingredients from FDA-regulated facilities and mandating the collection of side-effect data. Despite these additions, the move remains highly unusual, as regulatory authority over compounding pharmacies has historically rested with the FDA rather than the Department of Health and Human Services.
Reporting by Policy-Wire (PW)
