The Trump administration on Wednesday acted to ease access to unproven peptide drugs favored by Health Secretary Robert F. Kennedy Jr., and FDA scientific staffers had little input on the decision and opposed the changes, according to six people familiar with its development.

The new policy posted online by Kennedy’s Department of Health and Human Services (HHS) covers a handful of injectable peptides promoted within the wellness industry for uses such as building muscle, healing injuries, and boosting energy.

The policy, spearheaded by HHS, faced overwhelming pushback among FDA drug staffers who warned it could undermine the agency’s long-standing mission of keeping unproven health products off the U.S. market, according to the people familiar with its development.

The people spoke to the Associated Press on the condition of anonymity to discuss confidential government deliberations.

The policy directs the FDA not to take action against specialty pharmacies that sell a half-dozen wellness peptides, including BPC-157, TB-500, and KPV.

Under FDA rules, those chemicals would otherwise be considered illegal drugs because they have not gone through the agency’s rigorous review process for safety and effectiveness.

According to the newly posted document, Kennedy determined the change “advances patient choice and freedom” while protecting people in the U.S. 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.

Lee Rosebush of the American Academy of Peptide Medicine said in an online post that HHS had taken “a huge step for patient and provider medical freedom.”

The peptide business has caught the attention of major telehealth providers, including Hims & Hers, which recently 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.

Wellness Peptides Are Not FDA Approved

Some peptides occur naturally in the human body, where they trigger hormones needed for growth, metabolism, and healing. Drug companies have brought several to market as medications, including mainstay treatments for diabetes and weight loss such as semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound).

The chemicals subject to the new policy have not been approved as safe and effective by the FDA. Still, they are promoted for a range of medical uses, including for inflammatory conditions such as ulcerative colitis, wound healing, obesity, osteoporosis, opioid withdrawal, insomnia and narcolepsy, cerebral ischemia, migraine, and trigeminal neuralgia.

Peter Lurie, MD, MPH, a former FDA official, noted that the FDA has approved rigorously tested drugs for all of those conditions.

As people “are diverted from those drugs toward this stuff, there will be more unnecessary pain and suffering,” said Lurie, who now leads the nonprofit Center for Science in the Public Interest.

He also questioned the timing of the change, days before the midterm election.

“This is a wink and nod to the MAHA faithful in the hope that they’ll show up at the polls,” said Lurie, referring to Kennedy’s “Make America Healthy Again” movement.

RFK Jr. and His MAHA Followers Support Peptides

A spokesperson for HHS said the agency is “confronting the risks of black-market peptides” by giving Americans “a more controlled alternative through licensed U.S. compounders.”

It is the latest example of Kennedy reshaping U.S. health policy in the MAHA mold. Some of the biggest figures in that movement sell peptide injections and supplements.

The decision is a stark break from FDA efforts to limit the availability of unproven wellness products — including peptides, stem cell therapies, and dietary supplements — that make unsupported medical claims. But that approach put the agency at odds with Kennedy, who has publicly endorsed the benefits of all of those products.

The policy published Wednesday is a step back from HHS’ original plan, according to two of the people who discussed its development.

HHS officials initially wanted the FDA to draft an official regulation that would add BPC-157 and other peptides to a list of drug substances deemed safe for use by compounding pharmacies, specialty businesses that make customized medications.

FDA officials warned that the agency’s scientific staffers had major safety concerns and would not support a regulation deeming them safe. HHS officials moved to a different approach that directs the FDA not to enforce its rules against pharmacies that compound the substances.

FDA staffers ultimately provided technical assistance in drafting the HHS plan, including guardrails intended to improve safety, such as requiring pharmacies to use peptide ingredients from FDA-registered factories. Additionally, compounders are directed to collect information on side effects for safety analysis and verify the purity of peptides they use.

Lurie pointed out that the FDA, under federal law, does not have the authority to enforce those pharmacy requirements.

Decisions Over Compounding Have Long Rested With the FDA, Not HHS

Decisions about regulating peptides and compounding pharmacies have almost always come from the FDA, which has an office dedicated to protecting U.S. consumers from unsafe or poor-quality compounded drugs.

The issue of compounding safety became a greater focus for the FDA after a deadly outbreak of fungal meningitis in 2012 was linked to contaminated injections from a Massachusetts compounding pharmacy. Once a niche business, compounding has grown into a multibillion-dollar industry, providing customized medications to doctors, clinics, and hospitals.

It’s extremely rare for HHS to take the lead in drafting policies over the compounding industry, former FDA officials said. But federal law technically gives HHS authority over drug regulations, which are then delegated to the FDA.

FDA Has Warned Americans About Safety Risks of Unproven Peptides

Many in the U.S. who are using peptides today do not deal with a doctor or a pharmacy to get the injections, but often order vials online sold by chemical manufacturers based in China. Peptide sellers often try to skirt U.S. regulations by labeling their products as “for research use only” because the FDA does not regulate research chemicals.

In 2023, the FDA added more than a dozen peptides, including BPC-157 and TB-500, to its list of substances that should not be compounded due to risks of allergic reactions, kidney damage, and tumor growth.

At a meeting in July, FDA staffers reiterated that more than half a dozen peptides brought forward for reconsideration remained unproven in terms of safety and effectiveness.

But a panel of outside experts voted to drop restrictions on the six peptides named in Wednesday’s documents. The panel — selected by Kennedy’s HHS — included several doctors, pharmacists, and consultants who work in the peptide field.