U.S. health officials are moving forward with a plan to allow specialty pharmacies to make certain peptides, a type of largely unregulated injectable drug that has become popular with Health Secretary Robert F. Kennedy Jr. and other wellness influencers.
President Kennedy’s Department of Health and Human Services has submitted an “interim access policy” for peptides to the White House for review, according to a post on a government website Thursday. The plan was sent to the Office of Management and Budget, which reviews federal rules and regulations that can have significant economic consequences.
HHS officials did not immediately respond to a request for comment Thursday afternoon.
Peptides are building blocks of more complex proteins that trigger hormones in the body needed for growth, metabolism, and healing. Pharmaceutical companies bring several drugs to market as medicines, including leading treatments for diabetes and weight loss.
But the one at issue here has not gone through such a rigorous vetting process. Nevertheless, they are gaining a foothold among Americans interested in bulking up, looking younger, or boosting their energy. Their use has not been approved by the Food and Drug Administration, and most of the data on peptides comes from animal studies.
Before joining the administration, President Kennedy publicly declared that the “FDA’s war” on peptides and other health products would soon be over.
After taking office as health secretary, Kennedy said U.S. pharmacies must be allowed to sell peptides because Americans are increasingly turning to “gray market” peptides made in China and other countries. These products remain widely available for purchase through online platforms such as TikTok.
The new policy was not detailed in a White House filing, but two people familiar with the plan said it was intended to temporarily allow pharmacies to compound some of the most popular peptides, including BPC-157, a chemical that promotes muscle building and injury healing. The officials spoke on condition of anonymity to discuss confidential government deliberations.
The update is the latest sign that President Kennedy and other Trump administration officials are seeking to ease access to an unproven product popular in the “Make America Healthier” movement. Some of the major MAHA companies also sell peptide injections and supplements.
The FDA previously added BPC-157 and more than a dozen other injectable peptides to its list of substances too risky to dispense in pharmacies. Possible risks include contamination, allergic reactions and tumor growth, according to the FDA.
But earlier this year, President Kennedy directed government agencies to reconsider a short list of chemicals that have been widely touted by wellness influencers and fitness celebrities.
In July, an external FDA advisory committee recommended that FDA rescind restrictions on six of the seven peptides. This recommendation contradicts the scientific conclusions of FDA staff scientists, who reiterated that none of the peptides have been studied sufficiently to establish their safety and efficacy.
The new policy sent to the White House essentially guarantees compounding pharmacies — companies that specialize in compounding customized drugs not available from traditional drug companies — that they won’t be targeted for manufacturing certain peptides, according to people familiar with the plan. This approach, known as enforcement discretion, allows FDA to selectively choose not to enforce some of its own regulations.
Officially adding these peptides to the FDA’s list of safe-to-prepare drugs would require federal regulations, a process that could take years and require multiple rounds of public comment. It was not immediately clear whether the administration intended to continue moving forward with the process.
The proposal was quickly praised online by some of Kennedy’s allies who sell peptides.
“This is huge,” Brigham Buehler, a wellness clinic operator who sells peptides through an online service, posted on X. “This is not a question of being for or against peptides. It’s a question of being for or against medical freedom.”
The external expert panel that met in July was selected by the Kennedy Health Department and included several physicians, pharmacists, and consultants working in the peptide field.
The peptide business has attracted the attention of leading telemedicine providers including: him and her And Noom. The companies recently announced plans to make the peptides available to customers if the federal government eases access. Wall Street analysts predict the market could be worth between $2 billion and $3 billion.
