HHS peptide policy faces internal resistance at FDA

A draft policy currently under review at the White House would direct the Food and Drug Administration to stop enforcing regulations against specialty pharmacies that sell specific unproven peptides. The document is in its final regulatory stages, a process that typically precedes official publication. It represents a shift in how the government oversees a multibillion-dollar compounding industry.

Most FDA scientific staff members opposed the plan, according to six people familiar with the development. These experts warned that the approach could weaken the agency’s historical mission of keeping unverified health products off the U.S. market. The pushback was significant enough to alter the strategy proposed by the Department of Health and Human Services.

The policy targets injectable substances such as BPC-157 and TB-500. These chemicals are popular in the wellness sector for healing injuries and building muscle. International sports authorities classify them as doping substances. Because they have not completed the FDA’s rigorous review for safety and effectiveness, they are currently considered illegal drugs when sold as medications.

Health Secretary Robert F. Kennedy Jr. has publicly supported the use of these peptides. He described himself as a "big fan" and recently noted that he used BPC-157 to treat a muscle injury. Kennedy argues that Americans are turning to gray market products imported from China because domestic compounding pharmacies have been restricted from selling these ingredients.

HHS originally intended for the FDA to draft a formal regulation adding these peptides to a list of safe drug substances. FDA officials stated that their scientific staff had major safety concerns and would not support such a regulation. Consequently, HHS shifted to a guidance document that directs the agency not to take action against pharmacies selling the compounds.

FDA staffers provided technical assistance in drafting the current proposal. They included guardrails to improve safety, such as requiring pharmacies to source ingredients from FDA-regulated factories. Compounders will also be directed to verify the chemical identity of peptides and collect data on side effects for safety analysis.

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. At a meeting in July, FDA staff reiterated that more than a half-dozen peptides remained unproven in terms of safety and effectiveness.

Industry groups including the Alliance for Pharmacy Compounding have met with White House officials about the proposal and support the safety measures included in the draft. Decisions regarding compounding safety have almost always been made by the FDA, which maintains a dedicated office for protecting consumers from unsafe compounded drugs.