Regulatory Watch
Jul 2026: PCAC meets July 23–24 to review 7 peptides (BPC-157, TB-500, KPV, MOTS-c, DSIP, Semax, Epitalon) for 503A eligibility — docket FDA-2025-N-6895 • Jul 2026: FDA staff briefing docs: human evidence for BPC-157 and TB-500 is insufficient — the agency's own scientists weigh against 503A approval • Jun 2026: STAT/AP/NPR: new PCAC panel stacked with peptide-industry-conflicted members ahead of the July vote • Jun 2026: FDA sends ~25 more warning letters to telehealth firms over compounded GLP-1 marketing (net-impression claims) • Jun 2026: ADA 2026: retatrutide (TRIUMPH-1) posts up to ~28% mean weight loss at 80 weeks — but the grey-market version is a different product • Apr 2026: RECLASSIFICATION HAPPENS: FDA removes 12 peptides from Category 2 (April 15) — but "off Cat 2" is NOT "legal to compound" • Apr 2026: First real BPC-157 human RCT begins recruiting (Phase 2, ~120 subjects, hamstring injury) — NCT07437547 • Mar 2026: Semaglutide FAILS in early Alzheimer's (EVOKE/EVOKE+, The Lancet) — no cognitive benefit vs. placebo across ~3,800 patients • Mar 2026: FDA warning letters to 7 "research use only" peptide sites (Pink Pony, Mile High, PekCura, Prime Sciences, Gram Peptides) • Mar 2026: NPR covers peptide reclassification (March 26) — mainstream audience discovers peptide market • Mar 2026: 29 days post-RFK announcement: FDA has STILL not published reclassification — no Federal Register notice, no updated list • Mar 2026: SAFE Drugs Act filed as H.R. 6509 — bipartisan bill would ban RUO sales of compounds identical to FDA-approved drugs • Mar 2026: PolitiFact publishes peptide safety fact-check — documents gap between marketing claims and published evidence • Mar 2026: Hims & Hers vendor profile added — NYSE-listed telehealth company building peptide manufacturing in California • Mar 2026: 30+ clinic websites publishing reclassification articles — all financially conflicted, none independent • Mar 2026: BREAKING: Peptide Sciences shuts down operations (March 6) — largest grey-market vendor gone • Mar 2026: Finnrick data: Peptide Sciences BPC-157 scored A, but retatrutide scored E with counterfeit flagged across 37 samples • Mar 2026: MMM Online: 'Get ready for the peptides gold rush' — pharma trade media covers market explosion • Mar 2026: Jay Campbell: 'Federal government has decided RUO peptide manufacturing can no longer sell injectable peptides' • Mar 2026: Grips Intelligence: Peptide Sciences was doing $7.4M/month in sales before shutdown — market vacuum now open • Mar 2026: All American Peptide owners plead guilty — $3M+ forfeitures. Tailor Made Compounding: $1.79M forfeiture. • June 2025: FDA raids Amino Asylum warehouse; website goes offline, operations cease • Feb 2025: FDA declares semaglutide shortage resolved — compounding exception ends • Sept 2025: FDA issues 50+ warning letters to GLP-1 compounders; DOJ involvement confirmed • Nov 2025: Alabama obtains TRO against GLP-1 distributors — first state-level injunctive relief • Sept 2023: FDA moves BPC-157, TB-500, and 15 other peptides to Category 2 — compounding prohibited • Dec 2024: PCAC votes against allowing compounding of ipamorelin, MK-677, CJC-1295, AOD-9604 • Jan 2025: FDA eliminates Category 2/3 system; prohibited substances remain prohibited • Feb 2026: STAT News: 35 of 36 BPC-157 studies are animal-only from single lab with undisclosed conflicts • 2025: Chinese peptide imports to US double to $328M; online peptide advertising up 678% since 2022 • Jul 2026: PCAC meets July 23–24 to review 7 peptides (BPC-157, TB-500, KPV, MOTS-c, DSIP, Semax, Epitalon) for 503A eligibility — docket FDA-2025-N-6895 • Jul 2026: FDA staff briefing docs: human evidence for BPC-157 and TB-500 is insufficient — the agency's own scientists weigh against 503A approval • Jun 2026: STAT/AP/NPR: new PCAC panel stacked with peptide-industry-conflicted members ahead of the July vote • Jun 2026: FDA sends ~25 more warning letters to telehealth firms over compounded GLP-1 marketing (net-impression claims) • Jun 2026: ADA 2026: retatrutide (TRIUMPH-1) posts up to ~28% mean weight loss at 80 weeks — but the grey-market version is a different product • Apr 2026: RECLASSIFICATION HAPPENS: FDA removes 12 peptides from Category 2 (April 15) — but "off Cat 2" is NOT "legal to compound" • Apr 2026: First real BPC-157 human RCT begins recruiting (Phase 2, ~120 subjects, hamstring injury) — NCT07437547 • Mar 2026: Semaglutide FAILS in early Alzheimer's (EVOKE/EVOKE+, The Lancet) — no cognitive benefit vs. placebo across ~3,800 patients • Mar 2026: FDA warning letters to 7 "research use only" peptide sites (Pink Pony, Mile High, PekCura, Prime Sciences, Gram Peptides) • Mar 2026: NPR covers peptide reclassification (March 26) — mainstream audience discovers peptide market • Mar 2026: 29 days post-RFK announcement: FDA has STILL not published reclassification — no Federal Register notice, no updated list • Mar 2026: SAFE Drugs Act filed as H.R. 6509 — bipartisan bill would ban RUO sales of compounds identical to FDA-approved drugs • Mar 2026: PolitiFact publishes peptide safety fact-check — documents gap between marketing claims and published evidence • Mar 2026: Hims & Hers vendor profile added — NYSE-listed telehealth company building peptide manufacturing in California • Mar 2026: 30+ clinic websites publishing reclassification articles — all financially conflicted, none independent • Mar 2026: BREAKING: Peptide Sciences shuts down operations (March 6) — largest grey-market vendor gone • Mar 2026: Finnrick data: Peptide Sciences BPC-157 scored A, but retatrutide scored E with counterfeit flagged across 37 samples • Mar 2026: MMM Online: 'Get ready for the peptides gold rush' — pharma trade media covers market explosion • Mar 2026: Jay Campbell: 'Federal government has decided RUO peptide manufacturing can no longer sell injectable peptides' • Mar 2026: Grips Intelligence: Peptide Sciences was doing $7.4M/month in sales before shutdown — market vacuum now open • Mar 2026: All American Peptide owners plead guilty — $3M+ forfeitures. Tailor Made Compounding: $1.79M forfeiture. • June 2025: FDA raids Amino Asylum warehouse; website goes offline, operations cease • Feb 2025: FDA declares semaglutide shortage resolved — compounding exception ends • Sept 2025: FDA issues 50+ warning letters to GLP-1 compounders; DOJ involvement confirmed • Nov 2025: Alabama obtains TRO against GLP-1 distributors — first state-level injunctive relief • Sept 2023: FDA moves BPC-157, TB-500, and 15 other peptides to Category 2 — compounding prohibited • Dec 2024: PCAC votes against allowing compounding of ipamorelin, MK-677, CJC-1295, AOD-9604 • Jan 2025: FDA eliminates Category 2/3 system; prohibited substances remain prohibited • Feb 2026: STAT News: 35 of 36 BPC-157 studies are animal-only from single lab with undisclosed conflicts • 2025: Chinese peptide imports to US double to $328M; online peptide advertising up 678% since 2022
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Peptide Knowledge Base

Evidence-rated profiles for every major peptide. What the research shows, what it doesn't, and what vendors won't tell you.

Evidence Levels:
Animal Only Limited Human Moderate Human Well Established