FDA Enforcement Tracker

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

FDA staff briefing docs: human evidence for BPC-157 and TB-500 is insufficient — the agency's own scientists weigh against 503A approval

STAT/AP/NPR: new PCAC panel stacked with peptide-industry-conflicted members ahead of the July vote

FDA sends ~25 more warning letters to telehealth firms over compounded GLP-1 marketing (net-impression claims)

ADA 2026: retatrutide (TRIUMPH-1) posts up to ~28% mean weight loss at 80 weeks — but the grey-market version is a different product

RECLASSIFICATION HAPPENS: FDA removes 12 peptides from Category 2 (April 15) — but "off Cat 2" is NOT "legal to compound"

First real BPC-157 human RCT begins recruiting (Phase 2, ~120 subjects, hamstring injury) — NCT07437547

Semaglutide FAILS in early Alzheimer's (EVOKE/EVOKE+, The Lancet) — no cognitive benefit vs. placebo across ~3,800 patients

FDA warning letters to 7 "research use only" peptide sites (Pink Pony, Mile High, PekCura, Prime Sciences, Gram Peptides)

NPR covers peptide reclassification (March 26) — mainstream audience discovers peptide market

29 days post-RFK announcement: FDA has STILL not published reclassification — no Federal Register notice, no updated list

SAFE Drugs Act filed as H.R. 6509 — bipartisan bill would ban RUO sales of compounds identical to FDA-approved drugs

PolitiFact publishes peptide safety fact-check — documents gap between marketing claims and published evidence

Hims & Hers vendor profile added — NYSE-listed telehealth company building peptide manufacturing in California

30+ clinic websites publishing reclassification articles — all financially conflicted, none independent

BREAKING: Peptide Sciences shuts down operations (March 6) — largest grey-market vendor gone

Finnrick data: Peptide Sciences BPC-157 scored A, but retatrutide scored E with counterfeit flagged across 37 samples

MMM Online: 'Get ready for the peptides gold rush' — pharma trade media covers market explosion

Jay Campbell: 'Federal government has decided RUO peptide manufacturing can no longer sell injectable peptides'

Grips Intelligence: Peptide Sciences was doing $7.4M/month in sales before shutdown — market vacuum now open

All American Peptide owners plead guilty — $3M+ forfeitures. Tailor Made Compounding: $1.79M forfeiture.

STAT News: 35 of 36 BPC-157 studies are animal-only from single lab with undisclosed conflicts

Alabama obtains TRO against GLP-1 distributors — first state-level injunctive relief

FDA issues 50+ warning letters to GLP-1 compounders; DOJ involvement confirmed

FDA raids Amino Asylum warehouse; website goes offline, operations cease

FDA declares semaglutide shortage resolved — compounding exception ends

FDA eliminates Category 2/3 system; prohibited substances remain prohibited

Chinese peptide imports to US double to $328M; online peptide advertising up 678% since 2022

PCAC votes against allowing compounding of ipamorelin, MK-677, CJC-1295, AOD-9604

FDA moves BPC-157, TB-500, and 15 other peptides to Category 2 — compounding prohibited