Most FDA scientific staff opposed the policy, six people familiar said
The Department of Health and Human Services posted a policy document online on Wednesday directing the Food and Drug Administration 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 review process for safety and effectiveness. The document covers a handful of injectable peptides promoted within the wellness industry for building muscle, healing injuries and boosting energy.
Most FDA scientific staff members opposed the plan, according to six people familiar with its development who spoke to the Associated Press on condition of anonymity to discuss confidential government deliberations. The people said the scientific staff had limited input in drafting the policy, and that the effort 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. An HHS spokesperson did not immediately respond to a request for comment.
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 covered by the new policy have not been approved as safe and effective by the FDA.
Health Secretary Robert F Kennedy Jr has called himself a “big fan” of peptides and recently described using BPC-157 to treat a muscle injury. Kennedy has said US compounding pharmacies must be allowed to sell peptides because Americans are turning to “gray market” products imported from China and other countries.
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. FDA officials warned that the agency’s scientific staff had major safety concerns and would not support a regulation deeming them safe, and HHS officials moved to the different approach of directing the FDA not to enforce its rules against pharmacies that compound the substances.
FDA staff 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. According to two of the people, HHS also included several other measures suggested by FDA staff: compounders will be directed to collect information on side effects for safety analysis and to verify the chemical identity of peptides.
Decisions over compounding have long rested with the FDA, not HHS. Former FDA officials said it is extremely rare for HHS to take the lead in drafting policies over the compounding industry, though federal law technically gives HHS authority over essentially all drug regulations, which are then delegated to the FDA. The FDA 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.
Many people in the US who use peptides today do not deal with a doctor or a pharmacy to get the injections, and often order vials online from chemical manufacturers based in China. Peptide sellers often try to skirt US regulations by labeling their products “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 because of risks of allergic reactions, kidney damage and tumor growth. At a meeting in July, FDA staff reiterated that more than half a dozen peptides brought forward for reconsideration remained unproven in terms of safety and effectiveness.
The new policy avoids a direct confrontation with FDA staff because it only directs the agency not to enforce certain rules. The peptides covered by it still have not been approved as safe and effective by the FDA, and the policy stops short of the formal regulation HHS officials first sought.