Stopping short of a formal declaration allowing their use, Department of Health and Human Services secretary Robert F. Kennedy Jr. has cleared the way for the compounding of six popular wellness peptides.

The move, which comes after the same peptides won favor at an FDA advisory committee meeting this summer, is being hailed by some in the industry as offering a more accountable alternative to the gray market many peptide-seekers currently use, while others have charged that it undermines institutional FDA pushback on the drugs, which have become increasingly popular among fitness influencer circles and the MAHA crowd.

Under Kennedy’s “enforcement discretion policy” issued Wednesday, HHS will not take enforcement action against pharmacies, physicians and federal facilities compounding six specific peptides, assuming those parties meet certain specific qualifications.

The specific compounds included (PDF) in the list are BPC-157, epitalon, KPV, MOTS-c, semax and TB-500, all of which were discussed in a meeting of the FDA’s Pharmacy Compounding Advisory Committee (PCAC) in July, with the panel ultimately voting to recommend including the treatments onto the 503A Bulk Drug Substances list.

Advisory committee votes are recommendations, not binding decisions, and the peptides still haven’t been added to the drug substances list in an official capacity.

Kennedy cited that meeting in his enforcement decision, alongside data on utilization pf peptides, noting that HHS believes there is “significant interest in the use of these peptides in compounding given the lack of availability of approved products.”

The letter clarifies that the agency may revisit the interim policy if it leads to new safety signals or product quality issues.

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