US MoCRA for Exosome Brands: Five Obligations and One Sentence
MoCRA (2022) is the first substantial US cosmetic framework in decades. Exosome brands need five obligations and one sentence from it.
The five obligations
| Obligation | Rule | Practical note |
|---|---|---|
| Facility registration | Biennial renewal; updates within 60 days of change | Overseas factories need a designated US Agent |
| Product listing | New products within 120 days; annual updates | First biennial renewals concentrated in 2026 — FDA added status fields and auto-reminders to Cosmetics Direct |
| Adverse events | Serious AE reports within 15 working days | Applies even below the registration threshold |
| Record keeping | 6 years (3 for small businesses) | Safety substantiation lives here |
| Labeling | Contact, responsible party, warnings | INCI naming is the standard — INCI 41316 on the EV ingredient |
The exemption myth: brands under $1M annual US sales are excused from registration and listing — but not from adverse-event reporting, safety substantiation or labeling. Small is not exempt.
The one sentence to get right
The compliant phrase is "made in an FDA-registered facility" — never "FDA-approved product." Cosmetics are not approved; facilities are registered, products are listed. Exosome marketing that blurs this line drifts toward the drug side of the boundary, where the FDA has already sent warning letters to exosome sellers.
Cosmetic or biologic? The claim line that decides.
US exosome positioning has a fork the aesthetic-surgery literature maps clearly: appearance-related claims stay cosmetic under MoCRA; therapeutic claims push the product toward biologic regulation, where the FDA has warned clinics marketing unapproved exosome injections. Our claims-discipline post turns that boundary into a working checklist.
Launch on a registered, documented chain · EU route in practice · Program playbooks
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