RFK Jr. orders FDA to stand down on six unapproved peptides, overruling agency's own scientists

Health and Human Services Secretary Robert F. Kennedy Jr. has directed the FDA not to take enforcement action against compounding pharmacies that prepare six specific unapproved peptide drugs — a move that effectively puts the substances on the market while bypassing the agency's standard approval process and overruling its own scientists.

The draft policy, titled 'Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances,' was filed Wednesday and made available on the Federal Register, with final publication expected around October 30. It covers six peptides: BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. A public comment period opens Friday and runs through November 13.

The policy does not grant FDA approval or establish that the peptides are safe or effective. Instead, it states that HHS will simply stop pursuing enforcement against licensed pharmacies and physicians that compound them — giving compounders a practical green light without formally reversing the FDA's earlier regulatory stance.

By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative.— Robert F. Kennedy Jr., HHS Secretary

Compounding pharmacies mix ingredients to prepare customized medications for individual patients. In 2023, the FDA removed the six peptides from the list of substances compounding pharmacies are permitted to use, citing safety concerns. Kennedy's new rule sidesteps formally undoing that action — instead, HHS simply declares it will not enforce it, according to Ars Technica.

Kennedy cited a July vote by an FDA advisory panel that recommended allowing the six peptides back into compounding. But that recommendation came after Kennedy added eight new members to the 12-member committee. According to Ars Technica, at least six of his additions have ties to peptide-related businesses and clinics, raising conflict-of-interest concerns. The July vote also went against the recommendations of FDA's own scientists, who said there is insufficient evidence of safety and effectiveness for each of the six peptides, according to CBS News.

Kennedy has said he uses some of the peptides himself and has called himself a 'big fan,' according to Ars Technica. The substances are popular among members of Kennedy's Make America Health Again movement, and several prominent MAHA figures and Kennedy allies sell them.

The policy sets conditions: pharmacies must use FDA-registered ingredient makers, obtain lab certificates for raw ingredients, require patient-specific prescriptions, and report serious side effects. An HHS spokesperson told CBS News that the requirements are meant to give patients 'an alternative to unregulated sellers' and that 'the policy does not grant FDA approval or establish clinical safety and effectiveness.'

The Secretary of HHS has determined that this limited enforcement-discretion policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients.— HHS policy document

Supporters in the peptide industry celebrated immediately. Brigham Buhler, who sells peptides through a wellness clinic, posted on X thanking Kennedy, President Trump, Calley Means, and Joe Rogan. Lee Rosebush, chair of the American Academy of Peptide Medicine — a group formed last year — thanked Kennedy and the Trump administration for what he called a 'forward-thinking, evidence-based approach.'

Critics were sharper. The Center for Science in the Public Interest warned in a statement released Tuesday that reports of harms from the peptides 'will continue to mount,' that pharmaceutical companies will have less incentive to conduct rigorous clinical trials if the substances are already widely available, and that the move could open the door for other unapproved products.

This does not resolve problems with untested products, safety risks, questionable ingredients, or misleading claims. In fact, we believe this will worsen what we have already seen — the harms from mass compounding hitting communities hard due to a lack of oversight to rein in bad actors. We need to follow the science, and the reality is that FDA itself has continued to sound the alarm on lackluster data on these peptides. Safety and efficacy aren't a nice-to-have; they are required.— Fred Mills, Chief Policy Officer, Americans for Safe and Effective Medicines

The policy's defenders argue that the safety concerns cited by FDA scientists are mainly hypothetical or 'inferential' and not based on observed harm in humans — though Ars Technica notes this is largely because there are few to no human studies showing either benefits or harms from the peptides.

The peptide question sits within a broader pattern of unregulated wellness products reaching consumers. A CBS News investigation published last week found that a laboratory test on an experimental peptide weight-loss drug called retatrutide — purchased from a bodega in Brooklyn — detected no peptide at all in the sample. A separate CBS News investigation last summer found dozens of clinics staffed by licensed physicians openly advertising retatrutide, which has not been reviewed by the FDA and remains in clinical trials by Eli Lilly.

The draft policy will remain in effect until the FDA finalizes a formal rule on compounded peptides. As of now, the FDA has not proposed one, meaning the enforcement discretion policy could remain operative indefinitely.

Why it matters — The policy creates a new pathway for unapproved drugs to reach patients through licensed pharmacies without the clinical trial evidence normally required — and sets a precedent for how far an HHS secretary can go in sidelining FDA scientists through administrative discretion alone.

Sources differ on Whether the safety concerns around the six peptides are meaningful: Safety concerns are mainly hypothetical or 'inferential,' not based on observed human harm — cited by HHS as partial justification for the policy. (arstechnica.com) vs FDA scientists say there is insufficient evidence of safety and effectiveness; critics say reports of harms are already mounting. (cbsnews.com)

Reported by cbsnews.com, arstechnica.com, reuters.com, washingtonpost.com