HHS Eases Rules on Unproven Peptides

The Trump administration published a draft policy on Wednesday that instructs the Food and Drug Administration to stop enforcing rules against specialty pharmacies that sell six wellness peptides. The Department of Health and Human Services posted the document online and will accept public comments for two weeks.

The policy covers injectable peptides including BPC-157, TB-500, and KPV. Under current FDA rules, these chemicals are considered illegal drugs because they have not completed the agency's rigorous review process for safety and effectiveness. The new guidance directs the FDA not to take action against pharmacies selling these substances, provided the pharmacies follow specific safety protocols.

Health Secretary Robert F. Kennedy Jr. determined the change advances patient choice and freedom. He stated the measure protects Americans from peptides sold online that are often made from unscreened ingredients. Kennedy has called himself a big fan of peptides and previously described using BPC-157 to treat a muscle injury.

Six people familiar with the development said FDA scientific staffers had little input on the decision and opposed the changes. The FDA warned that its staff had major safety concerns and would not support a regulation deeming the peptides safe. Instead, HHS moved to a different approach that directs the FDA not to enforce its rules against compounding pharmacies.

The policy includes guardrails intended to improve safety. Pharmacies are required to use peptide ingredients from FDA-registered factories and must collect information on side effects for safety analysis. They are also directed to verify the purity of the peptides they use. Dr. Peter Lurie of the Center for Science in the Public Interest noted that federal law does not give the FDA the authority to enforce those pharmacy requirements.

Wall Street analysts estimate the peptide market could be worth more than $2 billion. Major telehealth providers, including Hims & Hers, have announced plans to offer wellness peptides once the government changes its policy. Lee Rosebush of the American Academy of Peptide Medicine said the move takes a huge step for patient and provider medical freedom.

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. A panel of outside experts selected by HHS voted in July to drop restrictions on the six peptides named in the new document. The panel included doctors, pharmacists, and consultants who work in the peptide field.