WASHINGTON — The Trump administration moved Wednesday to make several unproven peptide drugs more accessible, advancing a policy favored by Health Secretary Robert F. Kennedy Jr. Six people familiar with the matter said FDA scientists had limited involvement in developing the proposal and strongly objected to the changes.
The draft policy, released online by Kennedy’s Department of Health and Human Services, applies to a small group of injectable peptides marketed by the wellness industry as tools for building muscle, speeding recovery from injuries and increasing energy. The public will have two weeks to submit comments before the policy is finalized.
HHS officials were primarily responsible for writing the proposal, which encountered intense resistance from FDA drug experts. Those staff members warned that the plan could weaken the agency’s traditional role of keeping potentially dangerous health products off the US market, according to the people familiar with the discussions.
The individuals spoke with The Associated Press anonymously because they were not authorized to discuss internal government deliberations.
Under the proposal, the FDA would generally not pursue enforcement against specialty pharmacies distributing about six wellness peptides, including BPC-157, TB-500 and KPV. Under existing FDA standards, the substances would typically be treated as illegal drugs because they have not undergone the agency’s required testing for safety and effectiveness.
Kennedy wrote that the policy “advances patient choice and freedom.” The document also says the change would offer protection from peptides sold online that may be produced with ingredients whose source and quality are uncertain.
Kennedy has publicly described himself as a “big fan” of peptides and has said he used BPC-157 while treating a muscle injury.
Lee Rosebush, of the American Academy of Peptide Medicine, called the announcement “a huge step for patient and provider medical freedom” in an online statement. The organization is not a medical professional society and represents individuals who prescribe or market peptides.
The growing peptide market has also drawn major telehealth companies. Hims & Hers recently said it planned to offer wellness peptides if the government revised its policy, while Wall Street analysts have estimated that the industry could eventually exceed $2 billion.
Wellness peptides are not FDA approved
Some peptides are naturally produced by the body and help activate hormones involved in growth, metabolism and tissue repair. Pharmaceutical companies have developed approved medicines based on several peptides, including widely used treatments for diabetes and weight loss.
The compounds addressed by the new policy, however, have not been cleared by the FDA as safe and effective. They are nevertheless heavily promoted online by influencers and celebrities for conditions ranging from insomnia, anxiety and inflammation to migraines.
Peter Lurie, a former FDA official, said the agency already has approved medications that have been thoroughly tested for each of those conditions.
If patients “are diverted from those drugs toward this stuff, there will be more unnecessary pain and suffering,” said Lurie, who now heads the nonprofit Center for Science in the Public Interest.
Lurie also raised questions about the timing of the announcement, which came only 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,” Lurie said, invoking Kennedy’s “Make America Healthy Again” movement.
RFK Jr. and his MAHA followers support peptides
An HHS spokesperson said the department was addressing the dangers of “black-market peptides” by providing Americans “a more controlled alternative through licensed US compounders.”
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The move represents the latest effort by Kennedy to steer US health policy toward the priorities of the MAHA movement, whose prominent supporters include people who sell peptide injections and supplements.
It also marks a significant departure from previous FDA campaigns targeting unproven wellness products, including peptides, stem cell treatments and dietary supplements making unsupported medical claims. That enforcement posture repeatedly placed the agency at odds with Kennedy, who has publicly promoted the potential benefits of each category.
Two people familiar with the policy’s development said the version released Wednesday was less sweeping than HHS’ initial proposal.
The department initially sought to have the FDA write a formal regulation placing BPC-157 and other peptides on a list of drug substances considered safe for use by compounding pharmacies — specialty businesses that prepare customized medications.
FDA officials warned that the agency’s scientific staffers had major safety concerns and would not support a regulation deeming the peptides safe. HHS officials moved to a different approach that directs the FDA not to enforce its rules against pharmacies that compound the substances.
FDA staffers ultimately provided technical assistance in drafting the HHS plan, including guardrails intended to improve safety, such as requiring pharmacies to use peptide ingredients from FDA-registered factories. Additionally, compounders are directed to collect information on side effects for safety analysis and verify the purity of peptides they use.
Lurie pointed out that the FDA, under federal law, does not have the authority to enforce those pharmacy requirements.
The Alliance for Pharmacy Compounding, which represents specialty pharmacies, said several details need to be clarified — including when the policy takes effect and how it will intersect with state pharmacy boards, who traditionally regulate pharmacists.
Decisions over compounding have long rested with the FDA, not HHS
Decisions about regulating peptides and compounding pharmacies have almost always come from the FDA, which has an office dedicated to protecting US consumers from unsafe or poor-quality compounded drugs.
The issue of compounding safety became a greater focus for the FDA after a deadly outbreak of fungal meningitis in 2012 was linked to contaminated injections from a Massachusetts compounding pharmacy. Once a niche business, compounding has grown into a multibillion-dollar industry, providing customized medications to doctors, clinics and hospitals.
It’s extremely rare for HHS to take the lead in drafting policies over the compounding industry, former FDA officials said. But federal law technically gives HHS authority over drug regulations, which are then delegated to the FDA.
FDA has warned Americans about safety risks of unproven peptides
Many in the US who are using peptides today do not deal with a doctor or a pharmacy to get the injections, but often order vials online sold by chemical manufacturers based in China.
Peptide sellers often try to skirt US regulations by labeling their products as “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 its list of substances that should not be compounded due to risks of allergic reactions, kidney damage and tumor growth.
At a meeting in July, FDA staffers reiterated that more than half a dozen peptides brought forward for reconsideration remained unproven in terms of safety and effectiveness.
But a panel of outside experts voted to drop restrictions on the six peptides named in Wednesday’s document. The panel — selected by Kennedy’s HHS — included several doctors, pharmacists and consultants who work in the peptide field.