• Analysis
FDA peptides policy: scientists opposed HHS move to ease access
Most FDA scientific staff opposed the FDA peptides policy posted Wednesday by the Department of Health and Human Services, which directs the agency not to act against specialty pharmacies selling unproven peptide drugs, according to six people familiar with its development.
What the HHS policy does
The FDA peptides policy was posted online Wednesday by Robert F Kennedy Jr's HHS, and it covers a handful of injectable peptides promoted within the wellness industry for building muscle, healing injuries and boosting energy.
Under FDA review rules, these substances would otherwise be considered illegal drugs because they have not passed the agency's rigorous process for safety and effectiveness.
The document directs the FDA not to take action against specialty pharmacies that sell a half-dozen wellness peptides. Those named in the report include:
- •BPC-157
- •TB-500
- •KPV
Peptides occur naturally in the body, triggering hormones needed for growth, metabolism and healing, and drug companies have brought several to market, including diabetes and weight-loss treatments.
Internal pushback and a scaled-back plan
According to two of the people familiar with its development, the posted document represents a step back from HHS's original plans. HHS officials initially wanted the FDA to draft an official regulation adding BPC-157 and other peptides to the list of drug substances considered safe for use by compounding pharmacies.
FDA officials warned that their scientific staffers had major safety concerns and would not support a regulation deeming the peptides safe, so HHS instead shifted to a non-enforcement approach.
FDA staffers ultimately provided technical assistance on the plan, including guardrails such as requiring pharmacies to use peptide ingredients from FDA-registered factories.
A question of authority and safety
Decisions over compounding have long rested with the FDA, not HHS, which nonetheless has an office dedicated to protecting consumers from unsafe compounded drugs. Former FDA officials said it is extremely rare for HHS to lead the drafting of compounding policies, though federal law technically gives HHS authority over essentially all drug regulations.
Kennedy has called himself a "big fan" of peptides.
The FDA's own prior findings weigh against the policy. In 2023 the agency 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 said more than half a dozen peptides brought forward for reconsideration remained unproven in terms of safety and effectiveness.
Compounding's expansion and gray-market pressure
Kennedy has said US compounding pharmacies must be allowed to sell peptides because Americans are turning to "gray market" products imported from China and other countries. Many US peptide users order vials online from chemical manufacturers based in China without a doctor or pharmacy, and sellers often label their products as "for research use only" to skirt regulation.
Compounding itself has changed scale and scrutiny over the past decade:
- •It has grown from a niche business into a multibillion-dollar industry supplying customized medications to doctors, clinics and hospitals.
- •It became a greater FDA safety focus after a deadly 2012 outbreak of fungal meningitis linked to contaminated injections from a Massachusetts compounding pharmacy.
HHS included safety measures beyond the FDA-registered sourcing requirement: compounders will be directed to collect information on side effects for safety analysis and to verify the chemical identity of the peptides.
Kennedy recently described using BPC-157 to treat a muscle injury. The six people spoke to the Associated Press on the condition of anonymity while discussing confidential government deliberations, and an HHS spokesperson did not immediately respond to a request for comment.
