HHS Draft Policy Shields Popular Peptides From FDA Enforcement

Washington health officials moved to protect a small group of injectable compounds from federal enforcement on Wednesday.

The Department of Health and Human Services posted a draft policy that directs the Food and Drug Administration to stand down when specialty pharmacies sell specific wellness peptides. The measure covers six substances, including BPC-157, TB-500, and KPV. These chemicals are currently considered illegal drugs under FDA rules because they have not completed the agency's standard review for safety and effectiveness.

Six people familiar with the development of the document told The Associated Press that FDA scientific staffers opposed the change. The agency's internal experts warned that the policy could weaken the government's long-standing effort to keep unproven products off the market. The HHS draft, primarily written by departmental staff, faced strong pushback within the FDA before being released for public comment.

Health Secretary Robert F. Kennedy Jr. has publicly supported the use of these peptides. He described BPC-157 as a treatment for a muscle injury and called himself a "big fan" of the compounds. In the newly posted document, Kennedy stated that the change "advances patient choice and freedom." The policy aims to protect consumers from peptides sold online that are often made from unscreened ingredients.

The proposal shifts the regulatory burden from the FDA to a new enforcement stance by HHS. Originally, HHS officials wanted the FDA to draft a regulation adding these 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. In response, HHS moved to a different approach that directs the FDA not to enforce its rules against pharmacies that compound the substances.

FDA staffers provided technical assistance in drafting the final plan. The document includes guardrails intended to improve safety. These requirements include mandating that pharmacies use peptide ingredients from FDA-registered factories. Compounders must also collect information on side effects for safety analysis and verify the purity of the peptides they use.

Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest, questioned the timing of the decision. The policy was released days before the midterm election. Lurie said the move serves as a signal to Kennedy's "Make America Healthy Again" movement. "This is a wink and nod to the MAHA faithful in the hope that they’ll show up at the polls," Lurie said. He also noted that the FDA has already approved rigorously tested drugs for conditions like insomnia, anxiety, and migraines, which are the primary targets for these new peptides.

Lee Rosebush of the American Academy of Peptide Medicine praised the action in an online post. She called it "a huge step for patient and provider medical freedom." Her group represents people who prescribe or sell peptides but is not a medical professional organization. The peptide business has attracted major telehealth providers, including Hims & Hers, which announced plans to offer wellness peptides once the government changed its policy. Wall Street analysts estimate the market could be worth more than $2 billion.

The Alliance for Pharmacy Compounding said several details need clarification. The group, which represents specialty pharmacies, asked when the policy takes effect and how it will interact with state pharmacy boards. State boards traditionally regulate pharmacists. Decisions over compounding have historically rested with the FDA, which has a dedicated office for protecting consumers from unsafe compounded drugs. The issue gained prominence after a 2012 outbreak of fungal meningitis linked to contaminated injections from a Massachusetts pharmacy.

An HHS spokesperson said the agency is "confronting the risks of black-market peptides" by offering a controlled alternative through licensed U.S. compounders. The government will accept public comments on the measure for two weeks. A panel of outside experts selected by HHS voted in July to drop restrictions on the six peptides. The panel included doctors, pharmacists, and consultants who work in the peptide field.