U.S. eases restrictions on six unapproved peptides despite FDA safety concerns

The policy, filed with the Federal Register on October 28, covers BPC-157, TB-500, KPV, MOTS-c, Semax and Epitalon. Under the measure, the Department of Health and Human Services (HHS) does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians that compound drugs using these substances, provided specified requirements are met.

Compounding involves combining or modifying drug ingredients to prepare medications tailored to individual patients. Under Section 503A of the Federal Food, Drug, and Cosmetic Act, pharmacies and physicians must meet certain conditions to qualify for exemptions from standard drug approval and manufacturing requirements.

The new policy requires patient-specific prescriptions and ingredients sourced from FDA-registered manufacturers. According to the HHS document, compounders must obtain certificates of analysis verifying the identity, purity and potency of the substances, as well as testing for potentially harmful contaminants, including heavy metals and bacteria.

Compounders must also report serious adverse events and product quality problems to the FDA and relevant state authorities. Products may contain only one active pharmaceutical ingredient to make it easier to identify the substance responsible for any adverse reaction.

The policy also specifies permitted forms of administration for individual peptides. Semax is covered for intranasal use, while KPV is limited to oral and topical formulations. Other substances are subject to different restrictions depending on their characteristics and available safety evidence.

The document was issued by the Health Secretary's office rather than the FDA, which ordinarily oversees drug regulation. It is scheduled for official publication on October 30, after which a two-week public comment period will begin.

HHS describes the measure as an interim enforcement policy while the FDA determines through rulemaking which peptide substances should be permitted for compounding. The Federal Register notice specifies that the policy does not establish legal rights and is not binding on HHS or the public.

Kennedy argued that the policy would provide patients with a more controlled alternative to products obtained through unregulated channels. The HHS document states that the measure "advances patient choice and freedom while appropriately protecting patient safety."

HHS cited significant demand for the peptides despite the absence of FDA-approved products. The department said its approach is intended to discourage the use of research-use-only peptides supplied by foreign manufacturers, which it considers a potential safety risk for American patients.

The decision follows a July meeting of the FDA's Pharmacy Compounding Advisory Committee, which recommended adding six of seven peptides under consideration to the list of substances permitted for compounding. FDA scientific staff had recommended against their inclusion, citing insufficient evidence of safety and effectiveness.

HHS cited additional information, including documented use of the substances and new quality-control records from FDA-registered manufacturers, to support its decision. The department said laboratory testing data addressed some of the deficiencies previously identified by FDA scientists.

In 2023, the FDA placed several peptides, including BPC-157 and TB-500, in a category identifying potential safety risks associated with compounding. The designation was removed on April 22, 2026, although HHS notes that neither the original classification nor its removal changed the substances' legal status under Section 503A.

Peptides are short chains of amino acids that perform various biological functions, including cell signaling and hormone regulation. While some peptide-based medications, such as insulin and GLP-1 drugs, are established treatments, the six substances covered by the policy have not received FDA approval.

Interest in experimental peptides has grown within online wellness communities, where they are promoted for muscle recovery, wound healing, weight management and anti-aging. Many of these claimed benefits lack sufficient evidence from human clinical trials.

The consumer advocacy group Public Citizen criticized Kennedy's decision, warning that expanding access to unapproved substances could expose patients to contamination, impurities and unknown adverse effects.

Compounded drugs are not individually reviewed by the FDA for safety, effectiveness or quality before reaching patients. The HHS document also states that the department may reconsider the interim policy if adverse reactions or product quality problems emerge.

The policy does not amount to FDA approval of the six peptides or establish that their claimed health benefits have been demonstrated.

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