REGULATORY
From a three-year ban to a two-wave reversal.
Timeline
Late 2023
FDA places 19 peptides on Category 2
FDA's Bulk Drug Substances list moves 19 peptides — including BPC-157, TB-500, MOTS-c — to Category 2, citing safety, stability, and characterization concerns. Compounding pharmacies stop production.
2024
Backlash & legal challenges
Compounding pharmacies, functional medicine practitioners, and patient advocacy groups challenge the decision. A ProPublica investigation surfaces adverse-event concerns. Multiple congressional letters request reconsideration.
January 2025
RFK Jr. confirmed as HHS Secretary
Robert F. Kennedy Jr. takes office as HHS Secretary. The MAHA (Make America Healthy Again) coalition makes peptide access a priority.
March 2026
Public statements
Kennedy publicly states the 2023 bans were 'based on insufficient evidence' and that 'Americans deserve access to compounds that have helped them.'
April 15, 2026
FDA announces removal of 12 peptides
FDA updates its Bulks Drug Substances list to remove 12 peptides from Category 2 and schedules PCAC meetings to consider their addition to the 503A bulks list.
July 23–24, 2026
Wave 1 PCAC hearing
FDA campus, Silver Spring, MD. PCAC reviews BPC-157, KPV, TB-500, MOTS-c (Day 1) and DSIP, Semax, Epitalon (Day 2). Public comment period precedes a committee vote.
Q1 2027 (est.)
Wave 2 PCAC hearing
Estimated review window for LL-37, GHK-Cu (injectable), DiHexa, Melanotan II, and PEG-MGF.
Still on Category 2
Seven peptides from the original 2023 list were not included in the April 2026 reclassification. Most are growth-hormone secretagogues, which the FDA has historically treated as overlapping with regulated GH therapies.
Tuesdays is monitoring future rulemaking cycles. Selank and Thymosin Alpha-1 in particular may be revisited.
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