FDA Staff Opposed New Peptide Rule in 6 to 1 Vote

Federal drug regulators have spent years debating how to handle injectable peptides that have become popular in the wellness sector. A new draft guidance would allow specialty pharmacies to sell these substances without the Food and Drug Administration taking enforcement action against them.

According to six people familiar with the development of the document, the majority of FDA scientific staff opposed the plan. The guidance specifically covers injectable peptides that have not completed the standard FDA review for safety and effectiveness. Under current rules, these substances are technically illegal drugs unless they are approved or exempted.

The proposal recently passed through regulatory review at the White House, a step that typically precedes final publication. Three of the sources stated that the final text would instruct the FDA not to act against specialty pharmacies selling specific peptides, including BPC-157 and TB-500. These compounds are promoted to help heal injuries and build muscle, and international sports authorities currently classify them as doping substances.

The guidance represents a shift from the Department of Health and Human Services' initial approach. HHS officials originally intended for the FDA to write a formal regulation adding these peptides to a list of safe substances for compounding pharmacies. FDA scientists raised major safety concerns and indicated they would not support a rule declaring the peptides safe. In response, HHS moved to a directive that focuses on non-enforcement rather than a formal safety determination, a strategy that reduces direct conflict with agency staff.

Health Secretary Robert F. Kennedy Jr. has been a vocal advocate for easier access to these drugs. He has described himself as a "big fan" of peptides and recently said he used BPC-157 to treat a muscle injury. Kennedy argues that American consumers are turning to "gray market" products imported from China because domestic options are limited. Many users currently order vials from Chinese chemical manufacturers that label the products "for research use only," a designation that allows sellers to bypass standard FDA regulations.

Despite the internal resistance, FDA staffers provided technical input on the final plan. The guidance includes safeguards requiring pharmacies to source ingredients from FDA-regulated factories. It also mandates that these pharmacies collect data on side effects and verify the chemical identity of the peptides before selling them. The Alliance for Pharmacy Compounding, an industry group that met with White House officials recently, supports these specific safety measures.

The decision places policy authority in the hands of HHS rather than the FDA, a rare occurrence in this regulatory area. The FDA maintains a dedicated office to oversee compounded drugs, a focus that intensified after a 2012 fungal meningitis outbreak linked to a Massachusetts compounding pharmacy. Former FDA officials note that while federal law grants HHS authority over drug regulation, it usually delegates this power to the FDA. The compounding industry has grown from a niche market into a multibillion-dollar sector.

In 2023, the FDA added more than a dozen peptides, including the ones covered by the new guidance, to a list of substances that should not be compounded due to risks such as allergic reactions and kidney damage. During a meeting in July, FDA staff reiterated that more than half a dozen peptides brought forward for reconsideration remained unproven for safety and effectiveness. The new guidance seeks to address that gap by allowing sales to continue under specific conditions.