FDA scientists opposed RFK Jr. peptide plan, AP reports

A plan to give Americans easier access to unproven peptide drugs favored by Health Secretary Robert F. Kennedy Jr. was opposed by most Food and Drug Administration scientific staff members, who had limited input in drafting the policy, according to six people familiar with its development ¹².

The document was posted online Wednesday by Kennedy's Department of Health and Human Services, or HHS ¹. It covers a handful of injectable peptides promoted within the wellness industry for building muscle, healing injuries and boosting energy ¹.

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 ¹. Under FDA rules, those chemicals would otherwise be considered illegal drugs because they have not gone through the agency's rigorous review process for safety and effectiveness ¹.

The effort on peptides, driven almost entirely by HHS, faced overwhelming pushback among FDA drug staffers who warned it could undermine the agency's long-standing mission of keeping unproven health products off the U.S. market, according to the people familiar with its development ¹². The people spoke to The Associated Press on the condition of anonymity to discuss confidential government deliberations ¹. An HHS spokesperson did not immediately respond to a request for comment ¹.

A step back from the original plan

The new document represents a step back from HHS' original plans, according to two of the people who discussed its development ¹. HHS officials initially wanted 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, specialty businesses that make customized medications ¹.

FDA officials warned that the agency's scientific staffers had major safety concerns and would not support a regulation deeming them safe ¹. HHS officials then moved to a different approach that directs the FDA not to enforce its rules against pharmacies that compound the substances ¹.

FDA staffers ultimately provided technical assistance in drafting the HHS plan, including guardrails intended to improve safety, such as requiring pharmacies to use peptide ingredients from FDA-registered factories ¹. HHS ultimately included several safety measures suggested by FDA staffers, according to two of the people ¹.

Kennedy has described himself as a fan of peptides and recently described using BPC-157 to treat a muscle injury ¹. Kennedy has said 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 ¹.

Why the safety warnings matter

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 due to risks of allergic reactions, kidney damage and tumor growth ¹. At a meeting in July, FDA staffers reiterated that more than half a dozen peptides brought forward for reconsideration remained unproven in terms of safety and effectiveness ¹.

Decisions about regulating peptides and compounding pharmacies have almost always come from the FDA, which has an office dedicated to protecting U.S. consumers from unsafe or poor-quality compounded drugs ¹. It's extremely rare for HHS to take the lead in drafting policies over the compounding industry, former FDA officials said ¹.

Many in the U.S. who are using peptides today do not deal with a doctor or a pharmacy to get the injections, but often order vials online sold by chemical manufacturers based in China ¹. Peptide sellers often try to skirt U.S. regulations by labeling their products as "for research use only" because the FDA does not regulate research chemicals ¹.

That matters because the policy avoids a direct confrontation with FDA staffers by only directing the FDA not to enforce certain rules, leaving the substances unapproved as safe and effective ¹.

The Record

1. Jan 1, 2012A deadly outbreak of fungal meningitis was linked to contaminated injections from a Massachusetts compounding pharmacy, focusing FDA attention on compounding safety ¹.
2. Jan 1, 2023The FDA added more than a dozen peptides, including BPC-157 and TB-500, to its list of substances that should not be compounded due to risks of allergic reactions, kidney damage and tumor growth ¹.
3. Jul 1, 2026At a meeting in July, FDA staffers reiterated that more than half a dozen peptides brought forward for reconsideration remained unproven in terms of safety and effectiveness ¹.
4. Oct 28, 2026Kennedy's Department of Health and Human Services posted the peptide policy online Wednesday ¹.

Sources

1. PBS NewsHour, “AP report: FDA scientists opposed the Trump administration's move to ease peptides access” (2026-10-28). pbs.org/newshour/health/ap-report-fda-scientists-opposed-the
2. ABC News, “FDA scientists opposed the Trump administration's effort to ease peptides access” (2026-10-28). abcnews.com/US/wireStory/fda-scientists-opposed-trump-admini

Found an error? Tell the newsroom. Corrections are noted at the top of the story.