U.S. health officials are moving forward with a plan to allow specialty pharmacies to produce certain peptides, a class of largely unregulated injections that have become popular among followers of Health Secretary Robert F. Kennedy Jr. and other wellness influencers.
Kennedy’s Department of Health and Human Services has submitted an “interim access policy” for peptides to the White House for review, according to an article posted Thursday on a government website. The plan was sent to the Office of Management and Budget, which reviews federal rules and regulations that could have a significant economic impact.
HHS officials did not immediately respond to requests for comment Thursday afternoon.
Peptides are the building blocks of more complex proteins, triggering hormones in the body needed for growth, metabolism and healing. Pharmaceutical companies have marketed several as drugs, including basic treatments for diabetes and weight loss.
But those in question here have not been subjected to this rigorous vetting process. Nonetheless, they have gained a foothold among Americans interested in bulking up, looking younger, or increasing their energy. These uses are not approved by the Food and Drug Administration and most data on peptides comes from animal studies.
Before joining the administration, Kennedy publicly declared that “the FDA’s war” on peptides and other wellness products would soon end.
After becoming Secretary of Health, Kennedy said that U.S. compounding pharmacies should be allowed to sell peptides because Americans were increasingly turning to “gray market” peptides made in China and other countries. These products remain widely available for purchase through online platforms like TikTok.
The White House filing does not provide details on the new policy, but two people familiar with the plan say it is intended to allow pharmacies to temporarily compound some of the most popular peptides, including BPC-157, a chemical promoted for building muscle and healing injuries. The people spoke on condition of anonymity to discuss confidential government deliberations.
The update is the latest indication that Kennedy and other Trump administration officials are seeking to ease access to unproven products that are popular within the Make America Healthy Again movement. Some of MAHA’s biggest personalities sell peptide injections and supplements.
The FDA previously placed BPC-157 and more than a dozen other injectable peptides on its list of substances too risky to compound in pharmacies. Possible risks include contamination, allergic reactions and tumor growth, according to the FDA.
But earlier this year, Kennedy asked the agency to reconsider a short list of chemicals widely promoted by wellness influencers and fitness celebrities.
In July, a group of external FDA advisors recommended that the agency drop its restrictions on six of the seven peptides submitted to it. This recommendation went against the scientific conclusion of FDA scientists, who reiterated that none of the peptides had been sufficiently studied to establish their safety and effectiveness.
The new policy sent to the White House would essentially assure compounding pharmacies — specialty companies that mix custom medications that aren’t available from traditional drugmakers — that they won’t be targeted to produce certain peptides, according to the people familiar with the plan. This approach, known as enforcement discretion, allows the FDA to selectively choose not to enforce some of its own regulations.
Formally adding the peptides to the FDA’s list of drugs that can be safely combined would require federal regulation, a process that could take years and involves several rounds of public comment. It was not immediately clear whether the administration still plans to move forward with this process.
The proposal was quickly praised online by some Kennedy allies who sell peptides.
“This is huge,” Brigham Buhler, a wellness clinic operator who sells peptides through an online service, posted on X. “It’s not about whether you’re for or against peptides. It’s about whether you’re for or against MEDICAL FREEDOM.”
The panel of outside experts 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 sector has attracted the attention of major telehealth providers, including Him and her and Noom. Both companies recently announced plans to offer peptides to their customers if the federal government makes them easier to access. Wall Street analysts estimate the market could be worth between $2 billion and $3 billion.
Gn bussni
