The Trump administration has advanced a Health and Human Services interim policy to let pharmacies compound popular peptides under enforcement discretion, a step Health Secretary Robert F. Kennedy Jr. has pressed for years against earlier FDA limits.
Federal health officials under Kennedy submitted the peptides interim access policy to the White House Office of Management and Budget this week, according to a government website posting reviewed Thursday. Breitbart reported the filing does not spell out every detail of the new approach.
Two people familiar with the plan said it would allow compounding pharmacies to temporarily produce some of the most sought-after peptides, including BPC-157, without being targeted for enforcement. The uses at issue are not approved by the Food and Drug Administration.
Kennedy has framed the move as a direct answer to patients already buying from unregulated channels. After taking office he said U.S. compounding pharmacies must be allowed to sell peptides because Americans were turning to “gray market” products made in China and other countries. Before joining the administration he declared that the “FDA’s war” on peptides and other wellness products would soon end.
The same products remain widely available for purchase on platforms like TikTok. Wall Street analysts estimate the market could reach $2 billion to $3 billion once access expands.
Earlier this year the health secretary directed the agency to reconsider a short list of chemicals widely promoted by wellness influencers and fitness celebrities. That order set the stage for the interim policy now sitting at OMB, which reviews federal rules with the potential for significant economic impact.
Formal addition of these substances to the FDA’s list of drugs considered safe for compounding would still require multi-year rulemaking and multiple rounds of public comment. It is not immediately clear whether the administration will also pursue that longer process. Enforcement discretion offers a faster temporary path.
Major telehealth companies have already positioned themselves for the change. Hims & Hers and Noom both recently announced plans to offer peptides to customers if the federal government eases access.
That commercial interest tracks the broader push inside the Make America Healthy Again movement, where some of the biggest figures sell peptide injections and supplements. The administration’s step fits a pattern of moving quickly on priorities once nominees and cabinet officials are in place, much as Senate progress on Trump’s surgeon general pick has kept health-focused personnel moving forward.
In July a panel of external FDA advisers recommended the agency drop its restrictions on six of the seven peptides put before them. That recommendation went against the scientific conclusion of the agency’s own staff scientists, who reiterated that none of the peptides had been studied enough to establish safety and effectiveness.
Most of the available data still comes from animal studies. The FDA had previously placed BPC-157 and more than a dozen other injectable peptides on its list of substances too risky to be compounded by pharmacies, citing possible risks that include contamination, allergic reactions and tumor growth.
The interim policy would sidestep that listing for a limited set of products through selective non-enforcement rather than an immediate revise of the rulebook. Compounding pharmacies mix customized medications that traditional drugmakers do not supply. Under the plan they would gain assurance they will not be targeted for producing the covered peptides.
HHS officials did not immediately respond to requests for comment Thursday afternoon. The White House filing itself stays high-level.
Wellness clinic operator Brigham Buhler, who sells peptides through an online service and is described as a Kennedy ally, quickly praised the proposal on X after the filing became known.
"This is huge. This isn’t about whether you’re for or against peptides. It’s about whether you’re for or against MEDICAL FREEDOM."
Buhler’s reaction underscores the stakes for clinics already operating in the space and for patients who have been forced into overseas or online gray-market supply chains. The policy aims to pull that demand back into U.S. pharmacies that can be monitored.
Trump administration officials have treated regulatory bottlenecks as obstacles that can be cleared when the facts and the public demand it. Similar urgency has shown up in other corners of the agenda, including resource exploration plans moving ahead in Greenland and the steady advancement of political support needed to keep those priorities intact.
Kennedy’s public case has stayed consistent from the campaign trail into the Cabinet: Americans were already seeking these compounds, the FDA’s prior restrictions pushed them toward foreign and unregulated sources, and domestic compounding under clear temporary rules is the safer alternative.
Whether the OMB review produces a final green light remains the next test. The two people familiar with the plan describe the intent as temporary access for some of the most popular peptides while longer questions about full listing stay open.
That sequence, directive earlier this year, external advisers in July, interim policy to the White House now, shows an administration willing to act on the evidence it has rather than wait for multi-year rulemaking that may never finish. The same drive appears when Trump backs candidates who will defend the agenda on the trail and when the White House keeps pressure on midterm races that will decide how long the window stays open.
Patients, clinics and telehealth firms now wait to see how far enforcement discretion will reach and which specific peptides make the temporary cut. The filing’s lack of granular detail leaves those questions for the review process itself.
What is already clear is the direction. After years of FDA listings that treated popular peptides as too risky to compound, Kennedy’s HHS has put a concrete alternative on the White House desk and tied it to the simple problem of Americans buying the same products from China and TikTok sellers instead.
Medical freedom means letting patients and licensed pharmacies operate in the open rather than driving demand underground. The interim policy is the first real test of whether that principle can beat bureaucratic inertia.