FDA Scientists Opposed Health Secretary's Push to Ease Access to Unproven Peptides

A plan to make unproven peptide drugs easier to obtain in the United States, favored by Health Secretary Robert F Kennedy Jr, was opposed by most scientific staff at the Food and Drug Administration, who had limited input in drafting it. That is according to six people familiar with the policy's development, who spoke to the Associated Press on condition of anonymity because they were discussing confidential government deliberations.

The Department of Health and Human Services (HHS) posted the document online on Wednesday. It covers a handful of injectable peptides promoted in the wellness industry for building muscle, healing injuries and boosting energy. An HHS spokesperson did not immediately respond to a request for comment.

The policy directs the FDA not to take action against specialty pharmacies that sell a half-dozen wellness peptides, including BPC-157, TB-500 and KPV. Under FDA rules, these chemicals would otherwise be treated as illegal drugs, because they have not gone through the agency's review for safety and effectiveness.

Some peptides occur naturally in the body, where they trigger hormones involved in growth, metabolism and healing. Drug makers have brought several to market, including leading diabetes and weight loss treatments. The substances covered by the new policy, however, have not been approved by the FDA as safe and effective. Kennedy has called himself a "big fan" of peptides and recently said he used BPC-157 to treat a muscle injury.

According to two of the people, the document is a step back from HHS's original plans. Officials there first wanted the FDA to write a formal regulation adding BPC-157 and other peptides to a list of substances considered safe for use by compounding pharmacies, which make customized medications. FDA officials responded that agency scientists had major safety concerns and would not back a regulation deeming the substances safe. HHS then shifted to directing the FDA not to enforce its rules against pharmacies that compound them.

FDA staff ultimately gave technical help on the plan, including safeguards such as requiring pharmacies to source peptide ingredients from FDA-registered factories. Compounders will also be directed to collect information on side effects for safety analysis and to verify the chemical identity of the peptides. The approach avoids a direct clash with FDA staff because it only tells the agency not to enforce certain rules.

Decisions on compounding have long rested with the FDA rather than HHS, which has an office dedicated to protecting consumers from unsafe or poor-quality compounded drugs. The agency's focus on the issue grew after a deadly fungal meningitis outbreak in 2012 was traced to contaminated injections from a Massachusetts compounding pharmacy. Once a niche business, compounding is now a multibillion-dollar industry serving doctors, clinics and hospitals. Former FDA officials said it is extremely rare for HHS to lead policy drafting on compounding, though federal law technically gives HHS authority over essentially all drug regulation, which it delegates to the FDA.

Kennedy has argued that US compounding pharmacies must be allowed to sell peptides because Americans are turning to "gray market" products imported from China and other countries. Many peptide users today skip doctors and pharmacies and order vials online from Chinese chemical manufacturers. Sellers often label products "for research use only" to sidestep US rules, since the FDA does not regulate research chemicals.

The FDA has previously warned about the risks. In 2023 it added more than a dozen peptides, including BPC-157 and TB-500, to its list of substances that should not be compounded, citing risks of allergic reactions, kidney damage and tumor growth. At a July meeting, agency staff reiterated that more than half a dozen peptides up for reconsideration remained unproven for safety and effectiveness.