FDA scientists opposed easier access to unproven peptides pushed by Kennedy
Most FDA scientific staff opposed a White House-bound plan easing access to injectable peptides such as BPC-157, sources say, as the policy moves toward publication.
Most scientific staff at the Food and Drug Administration opposed a Trump administration plan to make unproven injectable peptides easier for Americans to obtain, according to six people familiar with the policy’s development. The plan, championed by Health Secretary Robert F. Kennedy Jr., recently underwent White House regulatory review, typically the final step before publication.
The document covers certain peptides popular in the wellness industry. Under the policy, the Food and Drug Administration would not take action against specialty pharmacies that sell widely used peptides that have not gone through the agency’s review process for safety and effectiveness. Without that exemption, those substances would otherwise be considered illegal drugs, according to three of the people. The sources spoke to The Associated Press on the condition of anonymity to discuss confidential government deliberations. An HHS spokesperson did not immediately respond to requests for comment.
FDA drug staffers warned that the effort could undermine the agency’s longstanding mission of keeping unproven health products off the U.S. market, the people said. Limited FDA staff input went into drafting the policy, which was driven by the Department of Health and Human Services.
Some peptides occur naturally in the human body, where they trigger hormones needed for growth, metabolism and healing. Drug companies have brought several peptides to market as medications, including mainstay treatments for diabetes and weight loss. The substances covered by the new policy have not gone through that vetting process. They include BPC-157 and TB-500, which are promoted to help heal injuries and build muscle. Both are considered doping substances by international sports authorities.
Kennedy has called himself a “big fan” of peptides and recently described using BPC-157 to treat a muscle injury. He has said repeatedly that U.S. compounding pharmacies must be allowed to sell peptides because Americans are turning to “gray market” products imported from China and other countries.
The guidance now at the White House is a step back from HHS’s original plans, according to two of the people. HHS officials initially wanted the FDA to draft a formal regulation adding BPC-157 and other peptides to a list of drug substances deemed safe for use by compounding pharmacies, which make customized medications. FDA officials warned that agency scientists had major safety concerns and would not support a regulation deeming the substances safe. HHS then shifted to an approach directing the FDA not to enforce its rules against pharmacies that compound the substances.
FDA staffers did provide technical assistance in drafting the HHS plan, including safeguards intended to improve safety. Pharmacies would be required to use peptide ingredients from FDA-registered facilities, collect information on side effects for safety analysis and verify the chemical identity of peptides. Two of the people said HHS ultimately included several of the measures FDA staffers suggested. Some industry groups support those measures, including the Alliance for Pharmacy Compounding, which recently met with White House officials about the proposal.
Decisions about regulating peptides and compounding pharmacies have almost always rested with the FDA, which has an office dedicated to protecting Americans from unsafe or poor-quality compounded drugs. The issue of compounding safety drew greater focus after a deadly 2012 outbreak of fungal meningitis linked to contaminated injections from a Massachusetts compounding pharmacy. Compounding has since grown into a multibillion-dollar industry supplying customized medications to doctors, clinics and hospitals. Former FDA officials have said it is extremely rare for HHS to lead drafting policy over the compounding industry, although federal law gives HHS authority over essentially all drug regulations, which are then delegated to the FDA.
The FDA has warned Americans about the risks of unproven peptides. Many people now obtain injections without a doctor or pharmacy, ordering vials online from chemical manufacturers based in China. Sellers often label products “for research use only,” since the FDA does not regulate research chemicals. 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 because of risks of allergic reactions, kidney damage and tumor growth. At a July meeting, FDA staffers reiterated that more than half a dozen peptides brought forward for reconsideration remained unproven in terms of safety and effectiveness.
The pending policy avoids a direct confrontation with FDA staff because it only directs the agency not to enforce certain rules. Its outcome will determine whether the agency’s scientific objections carry weight once the document is published.
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