Health Secretary Robert F. Kennedy Jr. is moving closer to fulfilling his promise to loosen federal restrictions on peptides, with the Department of Health and Human Services submitting an interim access policy to the White House for review Thursday.
The proposal could allow specialty pharmacies to temporarily produce certain peptides that have gained popularity among Americans seeking to improve fitness, support recovery, and explore alternatives for their health and wellness needs. The policy was submitted to the Office of Management and Budget, which reviews federal rules and regulations with potentially significant economic effects.
Although the details have not been publicly released, two people familiar with the proposal said it is intended to allow pharmacies to compound some of the most popular peptides, including BPC-157, a substance promoted by wellness advocates for muscle development and injury recovery.
The move reflects Kennedy's longstanding criticism of the FDA's approach to peptides and other wellness products. Before joining the Trump administration, Kennedy declared that the agency's “war” on peptides would soon end. Since becoming health secretary, he has argued that Americans should have greater access to these compounds through U.S. pharmacies rather than being pushed toward unregulated products sold online or imported from overseas.
Peptides are short chains of amino acids that play important roles in biological processes, including hormone signaling, metabolism, growth, and healing. Some peptide-based medications are already approved for medical use, including treatments for diabetes and weight loss. Other compounds have attracted growing interest from fitness enthusiasts and wellness consumers, though many of their advertised benefits have not been established through sufficient clinical research.
Kennedy has argued that allowing American compounding pharmacies to provide certain peptides could offer consumers a more accessible domestic option. The proposed policy would reportedly use enforcement discretion, allowing the FDA to temporarily refrain from pursuing certain enforcement actions against pharmacies producing designated compounds.
That approach could offer a faster path to expanded access than formally changing the FDA's rules. Adding peptides to the agency's list of substances eligible for compounding would require a federal rulemaking process that could take years and involve multiple rounds of public comment.
The FDA has previously restricted BPC-157 and more than a dozen other injectable peptides over concerns about potential contamination, allergic reactions, and tumor growth. Agency scientists have also said the available evidence is insufficient to establish the safety and effectiveness of many of these compounds.
However, a panel of outside advisers convened by Kennedy's health department recommended in July that restrictions be lifted on six of the seven peptides presented for review. The recommendation offered a different assessment from FDA staff scientists and highlighted the ongoing debate over whether existing restrictions should remain in place.
The proposal has drawn support from figures in the wellness industry who view expanded access as a matter of consumer choice and medical freedom. Brigham Buhler, a wellness clinic operator who sells peptides through an online service, praised the development on X.
“This is huge,” Buhler wrote, adding that the issue was about “whether you’re for or against MEDICAL FREEDOM.”
Major telehealth providers are also preparing for a potential expansion of the market. Hims & Hers and Noom have announced plans to offer peptides to customers if federal restrictions are eased. Wall Street analysts estimate the market could be worth between $2 billion and $3 billion.
HHS has not publicly disclosed the full details of the proposal, and officials have not clarified whether the administration will also pursue formal changes to the FDA's compounding rules.
If implemented, the interim policy would mark a significant step in Kennedy's effort to reconsider federal limits on wellness products and expand the options available to American consumers. The proposal would not establish that every peptide is safe or effective, but it could create a new avenue for access while the debate over regulation, research, and consumer choice continues.
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