Peptide Policy: FDA Staff Opposed Enforcement Shift

Most scientific staff at the Food and Drug Administration voted against a plan to make certain injectable peptides easier to sell, according to six people familiar with the policy's development who spoke to the Associated Press on condition of anonymity. The Department of Health and Human Services published the document Wednesday. It directs the FDA not to take action against specialty pharmacies selling a half-dozen wellness peptides, including BPC-157, TB-500 and KPV.

Under current FDA rules, those substances are classified as illegal drugs because they have not cleared the agency's review for safety and effectiveness. Some peptides occur naturally in the body and drive hormones linked to growth, metabolism and healing. Drug makers have brought several to market, including treatments for diabetes and weight loss, but the compounds covered by this policy have not been approved. Health Secretary Robert F Kennedy Jr has called himself a "big fan" of peptides and recently said he used BPC-157 for a muscle injury.

Two of the six people said the document represents a retreat from the department's initial approach. Health officials first sought a formal regulation that would add BPC-157 and related peptides to a list of substances deemed safe for compounding pharmacies, which prepare customized medications. FDA officials replied that their scientists held serious safety concerns and would not endorse a rule declaring the substances safe. The department then pivoted to instructing the FDA to stop enforcing its rules against pharmacies that compound them.

FDA staff did provide technical assistance, including safeguards that require pharmacies to obtain peptide ingredients from FDA-registered factories. Compounders must also verify the chemical identity of the peptides and gather information on side effects for analysis. Because the approach only tells the agency not to enforce certain rules, it avoids a direct conflict with FDA staff. Decisions on compounding have historically rested with the FDA rather than the health department, which maintains an office dedicated to protecting consumers from unsafe or low-quality compounded drugs. Former FDA officials said it is rare for the department to lead policy drafting in this area, though federal law grants it authority over essentially all drug regulation and delegates that power to the FDA.

Kennedy has argued that US compounding pharmacies must be permitted to sell peptides because Americans are turning to "gray market" products imported from China and other countries. Many users now bypass doctors and pharmacies, ordering vials online from Chinese chemical manufacturers; sellers often label the products "for research use only" to avoid US rules, since the FDA does not regulate research chemicals. In 2023 the agency added more than a dozen peptides, including BPC-157 and TB-500, to its list of substances that should not be compounded, citing risks of allergic reactions, kidney damage and tumor growth. At a July meeting, agency staff repeated that more than half a dozen peptides under reconsideration remained unproven for safety and effectiveness.

The health department did not immediately respond to a request for comment.