FDA to Reverse 2023 Ban on Injectable Peptides

The U.S. Food and Drug Administration is preparing to reverse a 2023 ban on more than a dozen injectable peptides, allowing compounding pharmacies to produce them again for patient-specific needs, according to a senior administration official. The move follows public advocacy from Health and Human Services Secretary Robert F. Kennedy Jr., who has described the substances as beneficial for healing and pushed for their availability from regulated sources.

In September 2023, the FDA removed 14 peptides from its list of bulk drug substances eligible for compounding, citing significant safety risks including potential immunogenicity, toxicity, and impurities. These short chains of amino acids, which occur naturally in the body and mimic some hormonal functions, had gained popularity in wellness and integrative medicine circles for unproven claims related to tissue repair, anti-aging, immune support, and growth hormone stimulation. None had been approved by the FDA as safe or effective for such uses, and the agency noted a rise in marketing them for cosmetic and disease-fighting benefits without supporting clinical evidence.

Kennedy, in a late February appearance on the Joe Rogan...