HHS Policy Shifts Peptide Enforcement Power Away From FDA

The Trump administration moved on Wednesday to reduce regulatory barriers for six unproven peptide drugs, a policy shift that bypassed the Food and Drug Administration's traditional enforcement authority.

Health Secretary Robert F. Kennedy Jr. posted a draft policy online through the Department of Health and Human Services that targets injectable peptides promoted for muscle building, injury healing, and energy boosting. The government will accept public comments on the measure for two weeks.

Six people familiar with the development said FDA scientific staffers had limited input on the final decision and opposed the changes. The policy directs the FDA not to act against specialty pharmacies selling specific chemicals, including BPC-157, TB-500, and KPV. Under current FDA rules, these substances are illegal drugs because they have not completed the agency's review process for safety and effectiveness.

Kennedy stated in the document that the change advances patient choice and freedom while protecting consumers from unscreened ingredients sold online. He has previously described himself as a big fan of peptides and said he used BPC-157 to treat a muscle injury.

The business opportunity for these products is substantial. Wall Street analysts estimate the market could exceed $2 billion. Major telehealth providers, including Hims & Hers, have announced plans to offer wellness peptides once the government policy changes. Lee Rosebush of the American Academy of Peptide Medicine called the HHS action a huge step for medical freedom in an online post.

Critics note that the six peptides have not been approved by the FDA as safe or effective. They are currently marketed for conditions such as insomnia, anxiety, and migraines. Dr. Peter Lurie, a former FDA official and current head of the Center for Science in the Public Interest, warned that diverting patients from rigorously tested drugs toward unproven substances could lead to unnecessary pain and suffering.

Lurie also questioned the timing of the announcement, which came days before the midterm election. He described the move as a signal to Kennedy's Make America Healthy Again followers in the hope that they would turn out to vote. A spokesperson for HHS said the agency is confronting the risks of black-market peptides by providing a controlled alternative through licensed U.S. compounders.

The final policy represents a change from the original HHS plan. Officials initially wanted the FDA to draft a regulation adding the peptides to a list of safe substances for compounding pharmacies. FDA officials warned that their scientific staff had major safety concerns and would not support such a regulation. HHS then shifted to an enforcement-based approach that directs the FDA not to enforce its rules against pharmacies that compound the substances.

FDA staffers provided technical assistance in drafting the HHS plan, including requirements for pharmacies to use peptide ingredients from FDA-registered factories. Compounders are also directed to collect side effect information and verify peptide purity. Lurie noted that the FDA does not have the legal authority to enforce those specific pharmacy requirements under federal law.

The Alliance for Pharmacy Compounding said details need clarification, including the effective date and how the policy will interact with state pharmacy boards. Decisions on regulating peptides and compounding pharmacies have historically rested with the FDA, which maintains an office dedicated to consumer safety in this sector. This responsibility increased after a 2012 fungal meningitis outbreak linked to a Massachusetts compounding pharmacy. Former FDA officials said it is rare for HHS to lead policy drafting for the compounding industry, though federal law technically grants HHS authority over drug regulations.

In 2023, the FDA added 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 July meeting, FDA staffers reiterated that the six peptides remained unproven. However, a panel of outside experts selected by Kennedy's department voted to drop restrictions on these specific peptides. The panel included doctors, pharmacists, and consultants who work in the peptide field.