Most scientific staff members at the Food and Drug Administration opposed a Trump administration plan to make it easier for Americans to access unproven peptide drugs, according to six individuals familiar with the policy's development.
The plan, which focused on certain injectable peptides popular in the wellness industry, faced significant pushback from FDA drug staffers who warned it could undermine the agency’s mission to keep unproven health products off the U.S. market. These individuals spoke to the Associated Press on the condition of anonymity to discuss confidential government deliberations.
The policy would have directed the FDA not to take action against specialty pharmacies selling certain widely used peptides. These substances would otherwise be considered illegal drugs because they had not undergone the agency’s rigorous review process for safety and effectiveness.
Some peptides occur naturally in the human body and play roles in growth, metabolism, and healing. Drug companies have developed several peptides into medications for conditions such as diabetes and weight loss. However, the peptides targeted by the proposed policy, including BPC-157 and TB-500, have not undergone such vetting. They are promoted for healing injuries and building muscle and are classified as doping substances by international sports authorities.
Robert F. Kennedy Jr., who has expressed support for peptides and described using BPC-157 for a muscle injury, was the Health Secretary at the time. An HHS spokesperson did not immediately respond to requests for comment.
According to two individuals familiar with its development, the guidance document recently under review at the White House represented a scaled-back version of HHS' original intentions. Initially, HHS officials aimed for the FDA to draft an official regulation that would add BPC-157 and other peptides to a list of drug substances deemed safe for use by compounding pharmacies, which create customized medications.
However, FDA officials indicated that their scientific staff had major safety concerns and would not support a regulation deeming these peptides safe. Consequently, HHS officials shifted to an approach that would instruct the FDA not to enforce its rules against pharmacies compounding these substances. FDA staffers provided technical assistance in drafting this revised plan, including safety measures such as requiring pharmacies to use peptide ingredients from FDA-regulated factories.
Kennedy has argued that U.S. compounding pharmacies should be permitted to sell peptides, citing that Americans are already turning to "gray market" products imported from other countries.
Decisions regarding the regulation of peptides and compounding pharmacies have historically been made by the FDA. The agency has a dedicated office focused on protecting Americans from unsafe or poor-quality compounded drugs. The issue of compounding safety gained prominence for the FDA following a 2012 deadly fungal meningitis outbreak linked to contaminated injections from a compounding pharmacy.
Compounding, once a niche business, has evolved into a multibillion-dollar industry providing customized medications. Federal law technically grants HHS authority over drug regulations, which are then delegated to the FDA. It is uncommon for HHS to lead policy development concerning the compounding industry.
Many individuals currently using peptides obtain them directly from chemical manufacturers, often based in China, and label them for "research use only" to circumvent U.S. regulations. In 2023, the FDA added over a dozen peptides, including BPC-157 and TB-500, to its list of substances unsuitable for compounding due to risks of allergic reactions, kidney damage, and tumor growth. At a July meeting, FDA staffers reiterated that numerous peptides under reconsideration lacked sufficient evidence of safety and effectiveness.
The policy pending at the White House circumvents a direct conflict with FDA staff by directing the agency not to enforce certain rules, rather than creating new regulations. HHS incorporated several safety measures proposed by FDA staff, such as requiring compounders to collect data on side effects and verify peptide chemical identity, in addition to sourcing from FDA-registered facilities. These measures have received support from some industry groups, including the Alliance for Pharmacy Compounding.