A plan to give people in the United States easier access to unproven peptide drugs favored by the US health secretary, Robert F Kennedy Jr, was opposed by most Food and Drug Administration scientific staff members, who had limited input in drafting the policy, according to six people familiar with its development.
The document posted online on Wednesday by Kennedy’s Department of Health and Human Services (HHS) covers a handful of injectable peptides promoted within the wellness industry for building muscle, healing injuries and boosting energy.
The effort on peptides, driven almost entirely by HHS, faced overwhelming pushback among FDA drug staffers who warned it could undermine the agency’s longstanding mission of keeping unproven health products off the US market, according to the people familiar with its development.
The people spoke to the Associated Press on the condition of anonymity to discuss confidential government deliberations. An HHS spokesperson did not immediately respond to a request for comment.
The policy directs the FDA not to take action against specialty pharmacies that sell a half-dozen wellness peptides, including BPC-157, TB-500 and KPV. Under FDA rules, those chemicals would otherwise be considered illegal drugs because they have not gone through the agency’s rigorous review process for safety and effectiveness.
Some peptides occur naturally in the human body, where they trigger hormones needed for growth, metabolism and healing. Drug companies have brought several to market as medications, including mainstay treatments for diabetes and weight loss. But the chemicals subject to the new policy haven’t been approved as safe and effective by the FDA.
Kennedy has called himself a “big fan” of peptides and recently described using BPC-157 to treat a muscle injury.
The new document represents a step back from HHS’s original plans, according to two of the people who discussed its development.
HHS officials initially wanted the FDA to draft an official regulation that would add BPC-157 and other peptides to a list of drug substances deemed safe for use by compounding pharmacies, specialty businesses that make customized medications.
FDA officials warned that the agency’s scientific staffers had major safety concerns and would not support a regulation deeming them 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.
Decisions over compounding have long rested with the FDA, not HHS.
Kennedy has said that US compounding pharmacies must be allowed to sell peptides because Americans are turning to “gray market” products imported from China and other countries.
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. However, federal law technically gives HHS authority over essentially all drug regulations, which are then delegated to the FDA.
The 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.
The new policy from HHS avoids a direct confrontation with FDA staffers because it only directs the FDA not to enforce certain rules.
HHS ultimately included several safety measures suggested by FDA staffers, according to two of the people. Besides sourcing ingredients from FDA-registered facilities, compounders will be directed to collect information on side effects for safety analysis and verify the chemical identity of peptides.
