HHS Eases Rules on Wellness Peptides

Health Secretary Robert F. Kennedy Jr. moved to allow specialty pharmacies to sell several unproven wellness peptides without standard FDA approval.

The Trump administration posted a draft policy on Wednesday that targets specific injectable compounds promoted for muscle building and energy boosting. The Department of Health and Human Services will accept public comments on the measure for two weeks. The document primarily directs the FDA not to take enforcement action against pharmacies selling these substances.

FDA scientific staffers opposed the changes, according to six people familiar with the deliberations. These individuals told The Associated Press that the agency’s long-standing mission is to keep unproven health products off the U.S. market. The policy covers a small number of peptides, including BPC-157, TB-500, and KPV. Under current rules, these chemicals are considered illegal drugs because they have not completed the rigorous review process for safety and effectiveness.

Kennedy stated that the change advances patient choice and freedom while protecting consumers from unscreened ingredients sold online. He has previously described using BPC-157 to treat a muscle injury. Lee Rosebush of the American Academy of Peptide Medicine called the move a huge step for medical freedom. The group represents individuals who prescribe or sell peptides and is not a medical professional organization.

The policy represents a shift from HHS’ original plan. Officials initially wanted the FDA to draft a regulation adding these peptides to a list of safe drug substances. FDA officials warned that their scientific staff had major safety concerns and would not support such a regulation. HHS then moved to a directive approach that tells the FDA not to enforce existing rules against compounding pharmacies.

FDA staffers provided technical assistance in drafting the final HHS plan. The document includes guardrails such as requiring pharmacies to use peptide ingredients from FDA-registered factories. Compounders must also collect side effect data and verify the purity of the peptides they use. Dr. Peter Lurie, a former FDA official and current head of the Center for Science in the Public Interest, noted that the FDA does not have legal authority to enforce these pharmacy requirements.

The Alliance for Pharmacy Compounding stated that details need clarification, including the effective date and how the policy intersects with state pharmacy boards. Decisions over compounding have historically rested with the FDA. This includes efforts to protect consumers from unsafe compounded drugs, a focus that intensified after a 2012 fungal meningitis outbreak linked to a Massachusetts pharmacy. Former FDA officials said it is rare for HHS to lead policy drafting in this sector.

Many consumers currently buy peptides online from chemical manufacturers, often in China. Sellers label these products for research use only to avoid FDA regulation. In 2023, the FDA added more than a dozen peptides 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 these peptides remained unproven. However, a panel of outside experts selected by HHS voted to drop the restrictions on the six peptides named in the new document.