FDA Staffers Oppose Draft Rule: New Guidance Would Allow Sale of Unproven Peptides

The majority of scientific staff at the Food and Drug Administration opposed a new policy designed to make unproven peptide drugs easier for consumers to purchase.

Six people familiar with the drafting process said the guidance was developed with limited input from agency scientists. The document currently covers injectable peptides popular in the wellness industry. It recently completed regulatory review at the White House, a step that usually precedes final publication.

The proposal instructs the FDA not to take action against specialty pharmacies that sell specific peptides. Without this exception, these substances are considered illegal drugs because they have not passed the agency's standard review for safety and effectiveness. The policy specifically targets compounds like BPC-157 and TB-500. International sports authorities classify these substances as doping aids, and they are marketed for injury healing and muscle building.

Health Secretary Robert F. Kennedy Jr. has described himself as a fan of these compounds. He recently stated that he used BPC-157 to treat a muscle injury. The new guidance represents a shift from the Department of Health and Human Services' original plan. Officials initially wanted the FDA to write a formal regulation adding these peptides to a list of safe substances for compounding. FDA scientists warned of major safety concerns and refused to support a rule that would deem the peptides safe.

HHS subsequently changed its approach to direct the FDA to stop enforcing rules against pharmacies that compound these drugs. This method avoids a direct conflict with FDA staff. Agency employees did provide technical assistance on the final plan. They included safeguards requiring pharmacies to source ingredients from FDA-regulated factories and verify the chemical identity of the peptides.

The FDA added BPC-157 and TB-500 to a list of substances that should not be compounded in 2023 due to risks of allergic reactions, kidney damage, and tumor growth. At a meeting in July, FDA staffers noted that more than half a dozen peptides under reconsideration remained unproven for safety and effectiveness. HHS spokespersons did not immediately respond to requests for comment on the new guidance.