The Trump administration on Wednesday acted to ease access to unapproved peptide drugs favored by Health Secretary Robert F. Kennedy Jr., posting a draft policy that would direct the Food and Drug Administration not to take enforcement action against specialty pharmacies selling six specific peptides.
The peptides covered by the policy—BPC-157, TB-500, KPV, MOTS-c, Semax, and Epitalon—are promoted within the wellness industry for uses including muscle building, injury healing, and energy enhancement. Under standard FDA rules, these substances would be classified as illegal drugs because they have not undergone the agency's rigorous review process for safety and effectiveness. The policy directs the FDA to refrain from taking action against licensed compounding pharmacies that prepare these peptides, provided they meet certain safeguards such as using ingredients from FDA-regulated factories and requiring patient-specific prescriptions.
According to six people familiar with the policy's development who spoke to the Associated Press on the condition of anonymity, FDA scientific staffers had little input on the decision and opposed the changes. The document, primarily written by HHS officials, faced overwhelming pushback among FDA drug staffers who warned it could undermine the agency's longstanding mission of keeping unsafe health products off the market. FDA staffers did eventually provide technical assistance in drafting the HHS plan, including guardrails intended to improve safety, but their opposition to the fundamental approach remained unchanged.
Kennedy justified the policy as advancing "patient choice and freedom" while protecting Americans from black-market peptides often imported from China and other countries with ingredients of unknown origin and quality. "By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative," Kennedy wrote in the guidance document. An HHS spokesperson stated that the policy requires quality testing, safety reporting, traceable ingredients, and serious side-effect reporting to hold compounders accountable.
Critics, including Dr. Peter Lurie, a former FDA official now leading the Center for Science in the Public Interest, warned that the policy could divert patients from rigorously tested alternatives. Lurie noted that the FDA has already approved effective drugs for the conditions these peptides are promoted to treat—including insomnia, anxiety, inflammatory conditions, and migraines. "As people are diverted from those drugs toward this stuff, there will be more unnecessary pain and suffering," Lurie said.
The move reflects a broader shift in how the Trump administration is reshaping health policy under Kennedy's leadership. The peptide industry has attracted significant commercial interest: telehealth provider Hims & Hers announced plans to offer wellness peptides once the policy takes effect, and Wall Street analysts estimate the market could exceed $2 billion. The decision also marks a departure from past FDA efforts to limit the availability of unapproved wellness products, including stem cell therapies and dietary supplements making unsupported medical claims.
The draft policy is open for public comment through November 13, 2026, and will remain in place until the FDA finalizes any formal rule regarding compounded peptides. The FDA has not yet proposed such a rule. This represents an unusual move, as decisions about regulating compounding pharmacies have historically come from the FDA itself, which maintains an office dedicated to protecting Americans from unsafe or poor-quality compounded drugs.
