Kennedy Department Moves to Allow Unproven Peptide Sales

The Department of Health and Human Services posted a new policy on Wednesday that eases restrictions on the sale of six injectable peptides. The move allows specialty pharmacies to sell chemicals such as BPC-157, TB-500, and KPV without immediate regulatory action from the Food and Drug Administration. Health Secretary Robert F. Kennedy Jr. championed the change, citing patient choice and protection from unscreened online products.

Under current FDA rules, these substances are considered illegal drugs because they have not undergone the agency's standard review for safety and effectiveness. The new directive instructs the FDA to stand aside while licensed U.S. compounders sell these ingredients. This approach contrasts with the agency's historical practice of keeping unproven health products off the U.S. market.

Six people familiar with the internal deliberations stated that FDA scientific staffers opposed the changes. They reported having little input on the final decision. The staffers warned that the policy could undermine the agency's mission to ensure drug safety. These individuals spoke to The Associated Press on condition of anonymity to discuss confidential government discussions.

Kennedy has previously described himself as a big fan of peptides. He told the public that he used BPC-157 to treat a muscle injury. The policy document states that the change advances patient freedom while shielding Americans from peptides made from unscreened ingredients. The HHS spokesperson said the agency is confronting the risks of black-market peptides by offering a controlled alternative through licensed U.S. compounders.

The wellness peptide market has drawn interest from major telehealth providers. Hims & Hers recently announced plans to offer these products once government policy shifted. Wall Street analysts estimate the total market value could exceed $2 billion. The chemicals target a range of conditions, including insomnia, anxiety, and migraines, despite lacking FDA approval.

Dr. Peter Lurie, who leads the Center for Science in the Public Interest, criticized the timing of the decision. It occurred days before the midterm election. Lurie, a former FDA official, called it a wink and nod to Kennedy's Make America Healthy Again movement. He noted that the FDA has approved rigorously tested drugs for the same conditions these peptides target. He predicted unnecessary pain and suffering as patients divert from approved treatments.

The final policy represents a step back from HHS' original plan. Officials initially wanted the FDA to draft a regulation adding the peptides to a list of safe substances for compounding. FDA staff expressed major safety concerns and refused to support that regulation. HHS then shifted to a non-enforcement strategy. This directs the FDA not to enforce rules against pharmacies that compound the substances.

FDA staffers provided technical assistance in drafting the new plan. They included guardrails intended to improve safety. These requirements mandate that pharmacies use peptide ingredients from FDA-registered factories. Compounders must also collect side effect data and verify the purity of the peptides they use. Lurie pointed out that the FDA lacks the federal authority to enforce these specific pharmacy requirements.

Regulatory decisions regarding compounding have historically rested with the FDA. The agency maintains a dedicated office to protect consumers from unsafe compounded drugs. This focus intensified after a 2012 fungal meningitis outbreak linked to a Massachusetts pharmacy. While federal law gives HHS authority over drug regulations, it is rare for the department to lead policy drafting for the compounding industry.

Many consumers currently buy peptides from Chinese chemical manufacturers online. Sellers often label these vials as for research use only to skirt FDA regulations. In 2023, the FDA added more than a dozen peptides to a list of substances not suitable for compounding due to risks of allergic reactions, kidney damage, and tumor growth. A panel of outside experts selected by HHS voted to drop restrictions on the six peptides named in the new documents.