Regulatory Watch

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 • 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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