The White House is reviewing a proposal to broaden access to peptides that includes more patient protections than initially expected, according to people familiar with the matter.

Widening access to peptides has become a contentious issue at the health department. Most of the compounds haven’t undergone the strict testing required of drugs and can’t legally be sold for human use. Still, Health Secretary Robert F. Kennedy Jr. has enthusiastically backed the products, while staff scientists at the Food and Drug Administration have been more cautious.

This summer, a panel of external advisers and scientists at FDA disagreed about whether to expand availability of six peptides, including a popular compound promoted by podcaster Joe Rogan called BPC-157. A majority of the panel ultimately backed relaxed rules for the compounds in non-binding votes in July.

Since then, officials at the FDA and Department of Health and Human Services have worked to thread the needle between accommodating Kennedy’s enthusiasm for the products while addressing safety concerns raised by FDA scientists, according to the people, who requested anonymity to discuss internal deliberations. Kennedy’s principal deputy chief of staff Stefanie Spear has been involved in the discussions, the people said. On a temporary basis, the department has proposed setting enforcement priorities that essentially turn a blind eye and allow compounding pharmacies to make certain peptides, as long as they certify the identity and purity of the substances and report adverse events like harmful side effects, the people said.

Spokespeople for HHS and FDA did not respond to requests for comment on the policy process. Health officials have been weighing how to move forward with more flexibility for compounded peptides even as the Trump administration presses for more scrutiny of vaccines that are already highly regulated, some of the people said.

The proposal currently being reviewed by the White House would allow more access to the compounds without formally approving them or establishing that they’re safe and effective.

Peptides, which are short chains of amino acids, have exploded in popularity as wellness clinics, telehealth companies and podcasters promote their use for everything from muscle recovery and anti-aging to sleep and cognitive performance.

Unlike traditional drugs, however, most popular peptides haven’t undergone the rigorous clinical testing required for FDA approval, leaving regulators grappling with how to oversee the rapidly growing market. Compounding pharmacies make medications that are supposed to be tailored to individual patients, and their products are not FDA approved.

Requiring them to report serious adverse events would mark a departure from existing rules for traditional compounding pharmacies, which generally don’t have to report negative side effects to the FDA. The policy is currently under review and could change. It may be hard to implement the safety reporting under consideration.

The FDA shares oversight of the pharmacies with states. States license them and monitor day-to-day operations. A national group of pharmacy boards said this year it would develop a system for reporting and sharing information on adverse events from compounded drugs. The guardrails under consideration are meant to insulate compounders from state-level scrutiny and litigation, some of the people said.

“Americans are going to be buying these anyway. Our objective was to make sure that there is a regulated marketplace, so that what they’re getting is what they claim to be, that is safe, that the factories are inspected,” Kennedy said in a Fox News appearance on Tuesday.

Yet it’s still unclear what the department’s permanent position will be. Officials have discussed allowing FDA to issue a proposed regulation recommending against adding certain peptides to a list of substances eligible for use in traditional pharmacy compounding, the people said, essentially leaving current restrictions in place.

That position would align with the publicly stated concerns of FDA scientists. The policy would then undergo public comment before any final decision, and it’s unclear what the final product of that input could be. Kennedy has said he is a “big fan” of peptides, telling Rogan in February that he’s used them personally to treat injuries with good results.

He’s since pushed to make the compounds more widely available, arguing that restrictions imposed under the Biden administration drove consumers to an unregulated black market. This year Kennedy added several new members to the panel of external advisers that evaluates the products.

Several of the members have ties to the peptide industry and clinics that promote their use. Supporters say allowing licensed pharmacies to make peptides would give consumers access to products with more oversight and quality controls.

Kennedy’s endorsement has been a boon for companies like Hims & Hers Health Inc., which has said it plans to sell the compounds once legalized. However, his enthusiasm has raised concerns among medical experts and FDA reviewers, who’ve warned that many of the peptides popular in wellness circles have little evidence demonstrating their safety or effectiveness.

Critics say that pharmacy standards can’t substitute for clinical trials establishing whether the substances are safe and effective, and that expanding access could expose more Americans to potentially dangerous products.

Kennedy has the legal authority to determine regulations on peptide access, though normally that power is delegated to officials at the FDA.

It would be unusual for a secretary to override FDA officials, though not unprecedented. During the Obama administration, then-HHS Secretary Kathleen Sebelius overruled the FDA in 2011, after the agency had planned to make emergency contraception available over the counter without an age restriction. “This is the kind of decision that generally has been made by experts at FDA, and for good reason,” said Camila Strassle, a former assistant chief counsel at FDA and researcher at the University of Pennsylvania’s Department of Medical Ethics and Health Policy.

“They are the ones with the relevant expertise on any safety risks or other concerns with these kinds of medical products.”The temporary access policy is currently under review at the White House, where stakeholders will have a chance to weigh in. Organizations with meetings scheduled so far include the Alliance for Pharmacy Compounding, Hims and the American Academy of Peptide Medicine, according to a public meeting calendar.