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FDA tracker

Epitalon: FDA regulatory status

Research use onlyUpdated Apr 23, 2026

See tracker for current status.

Editorially reviewedThe Peptide Examiner editorial team, Editorial review · Reviewed Apr 23, 2026

Regulatory timeline

  1. Feb 27, 2026 · Reclassification

    HHS proposes removal from Category 2

    HHS Secretary RFK Jr. announced proposed removal of 14 peptides from Category 2. Final FDA determination pending PCAC review (July 2026 hearing).

  2. Sep 7, 2023 · Reclassification

    FDA places on Category 2 list

    Listed among 19 peptide bulk substances potentially raising significant safety risks for compounding. Prohibits compounding under Section 503A or 503B pending review.

What this means for patients

Epitalon is not FDA approved for human use. As of April 2026, it is on the FDA's Category 2 list, preventing US compounding pharmacies from legally preparing it. Research-peptide vendors selling it 'for research use only' face continuing FDA enforcement risk.