The Trump administration acted Wednesday to ease access to unproven injectable peptide drugs favored by Health Secretary Robert F. Kennedy Jr. Six people familiar with the policy’s development said Food and Drug Administration scientific staffers had little input and opposed the changes.

The draft policy from Kennedy’s Department of Health and Human Services covers several peptides promoted by the wellness industry for building muscle, healing injuries and boosting energy. The government will accept comments on the measure for two weeks.

The document was primarily written by HHS and encountered overwhelming resistance from FDA drug staffers. They warned that it could weaken the agency’s longstanding mission of keeping unproven health products off the United States market, according to people familiar with the confidential deliberations.

The policy directs the FDA not to act against specialty pharmacies selling six wellness peptides, including BPC-157, TB-500 and KPV. Under FDA rules, those chemicals would otherwise be considered illegal drugs because they have not completed the agency’s safety and effectiveness review process.

According to the document, Kennedy determined that the change “advances patient choice and freedom” while protecting people in the United States from peptides sold online and often made with unscreened ingredients. Kennedy has called himself a “big fan” of peptides and previously described using BPC-157 for a muscle injury.

Lee Rosebush of the American Academy of Peptide Medicine called the move “a huge step for patient and provider medical freedom.” The group is not a medical professional organization and represents people who prescribe or sell peptides.

The peptide business has also attracted major telehealth providers, including Hims & Hers, which announced plans to offer wellness peptides after the government changed its policy. Wall Street analysts estimate that the market could be worth more than $2 billion.

Some peptides occur naturally in the human body and trigger hormones needed for growth, metabolism and healing. Drug companies have marketed several as medications, including established treatments for diabetes and weight loss.

The chemicals covered by the new policy have not been approved by the FDA as safe and effective. Even so, they are promoted for medical uses that include insomnia, anxiety, inflammatory conditions and migraines.

Dr. Peter Lurie, a former FDA official who now leads the nonprofit Center for Science in the Public Interest, said the FDA has approved rigorously tested drugs for all those conditions. As patients “are diverted from those drugs toward this stuff, there will be more unnecessary pain and suffering,” Lurie said.

Lurie also questioned why the change arrived 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,” he said, referring to Kennedy’s “Make America Healthy Again” movement.

An HHS spokesperson said the agency is “confronting the risks of black-market peptides” by offering Americans “a more controlled alternative through licensed U.S. compounders.” The change is another instance of Kennedy reshaping United States health policy around the MAHA movement, whose prominent figures include sellers of peptide injections and supplements.

The published policy represents a retreat from HHS’ original plan, according to two people familiar with its development. HHS officials initially wanted the FDA to write a regulation adding BPC-157 and other peptides to a list of drug substances considered safe for use by compounding pharmacies.

FDA officials warned that scientific staffers had major safety concerns and would not support a regulation declaring the peptides safe. HHS instead pursued an approach directing the FDA not to enforce its rules against pharmacies that compound the substances.

FDA staffers ultimately provided technical help and added safeguards, including directions that pharmacies use peptide ingredients from factories registered with the FDA. Compounders are also directed to verify peptide purity and collect information about side effects for safety analysis, although Lurie said federal law does not authorize the FDA to enforce those pharmacy requirements.

The Alliance for Pharmacy Compounding said details remain unclear, including when the policy takes effect and how it will interact with state pharmacy boards. Such boards traditionally regulate pharmacists, while FDA decisions have generally governed peptides and compounding pharmacies.

Compounding safety became a greater FDA focus after contaminated injections from a Massachusetts pharmacy were linked to a deadly fungal meningitis outbreak in 2012. Compounding has since grown from a niche business into a multibillion dollar industry supplying customized medications to doctors, clinics and hospitals.

Many people using peptides obtain vials online from chemical manufacturers based in China rather than through doctors or pharmacies. Sellers often label the products “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 a list of substances that should not be compounded because of risks involving allergic reactions, kidney damage and tumor growth. FDA staffers reiterated at a July meeting that more than half a dozen peptides remained unproven for safety and effectiveness.

A panel of outside experts nevertheless voted to remove restrictions on the six peptides included in Wednesday’s document. The HHS selected panel included doctors, pharmacists and consultants who work in the peptide field.

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