By Salma El-Sakka
Food and Drug Administration scientific staff opposed a Trump administration plan to ease access to unproven peptide drugs favored by Health Secretary Robert F. Kennedy Jr., according to six people familiar with the policy development.
HHS Policy Directs FDA Not to Enforce Rules
The policy, posted Wednesday by the Department of Health and Human Services, covers a half-dozen injectable peptides promoted for muscle building, injury healing, and energy. These substances, including BPC-157, TB-500, and KPV, have not undergone FDA review for safety and effectiveness.
FDA Staff Warned of Safety Risks
The effort, driven almost entirely by HHS, faced overwhelming pushback from FDA drug staffers who warned it could undermine the agency's mission to keep unproven health products off the market. The sources spoke anonymously to discuss confidential deliberations.
Compounding Pharmacies and Gray Market
Under the new directive, the FDA is instructed not to take action against specialty pharmacies that sell the listed peptides. Normally, these chemicals would be considered illegal drugs without FDA approval. Kennedy has called himself a "big fan" of peptides and described using BPC-157 for a muscle injury. He argued that allowing compounding pharmacies to sell peptides would reduce reliance on "gray market" products imported from China.
Safety Measures Included
The document represents a step back from HHS's original plan to add the peptides to a list of substances deemed safe for compounding pharmacies, after FDA officials warned of major safety concerns. The new policy includes safety measures suggested by FDA staff, such as requiring pharmacies to source ingredients from FDA-registered facilities, collect side-effect data, and verify chemical identity. The FDA has previously warned about risks of unproven peptides, including allergic reactions, kidney damage, and tumor growth, and in 2023 added more than a dozen peptides to a list of substances that should not be compounded.
