FDA Scientists Resisted RFK Jr.'s Push to Loosen Rules on Unproven Peptides

A new federal policy easing access to certain unproven peptide drugs faced strong internal opposition from Food and Drug Administration scientists, according to people familiar with how the policy was developed.

The guidance, released online by the Department of Health and Human Services, tells the FDA not to take enforcement action against specialty pharmacies that compound and sell peptides such as BPC-157, TB-500 and KPV. These substances are popular in wellness circles for claims related to muscle building, injury recovery and energy, but they have not gone through FDA review for safety or effectiveness.

People familiar with the process said the effort was driven mainly by HHS rather than the FDA, and that most FDA drug-safety staff had limited involvement in shaping it. Many of those staffers reportedly raised concerns that the move could weaken the agency's standard practice of keeping unproven products off the market.

Health Secretary Robert F. Kennedy Jr. has spoken favorably about peptides, describing himself as a strong supporter and saying he used BPC-157 to treat a muscle injury. He has argued that allowing domestic compounding pharmacies to offer peptides would reduce reliance on unregulated products imported from countries such as China.

According to the people familiar with discussions, HHS originally sought a formal FDA regulation declaring the peptides safe for compounding, but FDA officials said their scientific staff would not support that due to safety concerns. HHS then shifted to the non-enforcement approach, incorporating certain safety measures proposed by FDA staff, including requirements that pharmacies use peptide ingredients from FDA-registered facilities and track side-effect data.

The FDA had previously flagged many of these peptides, including BPC-157 and TB-500, for risks such as allergic reactions, kidney damage and tumor growth, placing them on a list of substances unsuitable for compounding in 2023. At a meeting earlier this year, agency staff reiterated that the peptides remained unproven for safety and effectiveness.