FDA Science Staff Voted Against Peptide Policy

Most scientific staff at the Food and Drug Administration opposed a new policy that eases regulations on unproven peptide drugs, according to six people familiar with the process. The directive, favored by Health and Human Services Secretary Robert F. Kennedy Jr., was posted online on Wednesday. The document covers injectable peptides like BPC-157, TB-500, and KPV, which are marketed in the wellness industry for muscle building and energy boosting. Under current rules, these substances are considered illegal drugs because they have not passed FDA review for safety and effectiveness.

The policy instructs the FDA to refrain from taking action against specialty pharmacies that sell these compounds. This approach represents a shift from an earlier proposal by HHS. Officials initially wanted the FDA to issue a formal regulation adding the peptides to a list of safe substances for compounding pharmacies. Agency scientists raised major safety concerns and refused to back that regulation. HHS then moved to the current method, which directs the FDA not to enforce existing rules against pharmacies that compound the drugs.

Kennedy has described himself as a big fan of peptides. He recently stated that he used BPC-157 to treat a muscle injury. He argues that allowing compounding pharmacies to sell these products is necessary because Americans are turning to gray market imports from China and other countries. Many users order vials online from chemical manufacturers and label the products for research use only to bypass US regulations. The FDA does not regulate research chemicals.

FDA staff provided technical input on the final plan. The policy includes safeguards requiring pharmacies to source ingredients from FDA-registered factories. Compounders must also collect data on side effects and verify the chemical identity of the peptides. This structure avoids a direct conflict with FDA staff by simply telling the agency not to enforce specific rules rather than declaring the substances safe.

Compounding decisions have traditionally been made by the FDA, not HHS. HHS maintains an office dedicated to protecting consumers from unsafe compounded drugs. The agency’s focus on the issue increased after a 2012 fungal meningitis outbreak linked to a Massachusetts compounding pharmacy. Compounding has grown from a niche business into a multibillion-dollar industry serving doctors, clinics, and hospitals. Former FDA officials noted that it is rare for HHS to lead policy drafting on compounding, even though federal law grants HHS broad authority over drug regulation.

In 2023, the FDA added more than a dozen peptides, including BPC-157 and TB-500, to its list of substances that should not be compounded. The agency cited risks of allergic reactions, kidney damage, and tumor growth. At a meeting in July, agency staff reiterated that more than half a dozen peptides up for reconsideration remained unproven for safety and effectiveness. An HHS spokesperson did not immediately respond to a request for comment on the new policy.