A practical scenario: a Vietnamese cosmetics brand selling well at home brings goods to the US via e-commerce. It assumes cosmetics “aren’t drugs” so no FDA needed — then gets warned: since MoCRA, manufacturing facilities and each product must be registered/listed with FDA. Goods held at port for missing product listing. The “free cosmetics” era in America is over.
1. MoCRA: the new cosmetics rulebook in the US
MoCRA (Modernization of Cosmetics Regulation Act 2022) is the biggest modernization of US cosmetics law in decades. The core change: facility registration and product listing with FDA are now mandatory (previously voluntary). FDA also gained powers to: require good manufacturing practice (GMP), access product safety records, suspend facilities at risk, and mandate serious adverse-event reporting. Labels must list full ingredients in order, plus adverse-event contact information. Vietnamese brands selling into the US without MoCRA registration are walking a tightrope.
2. Vietnam: notification under ASEAN standards
In Vietnam, cosmetics follow the ASEAN Cosmetic Directive: companies file a cosmetic product notification before circulation — a notification procedure (not drug-style “approval registration”). Authorities check post-market: sampling, testing, penalties for banned substances or mislabeling. Versus MoCRA: Vietnam is lighter on pre-market (notification-based), but post-market checks are tightening — especially for imported and online-sold cosmetics.
3. A Vietnamese cosmetics US checklist
- Facility registration + product listing with FDA under MoCRA — before goods hit shelves.
- GMP: compliant manufacturing — FDA may inspect.
- Labeling: full ordered ingredient lists, adverse-event contacts — Vietnamese labels often lack these.
- Product safety: safety substantiation records — FDA may demand to see them.
- US Agent: designate one for FDA registration — the contact point for FDA outreach.
MoCRA: register first, sell later
This article is general information. Each product needs its own procedures. FLAT Law Firm helps companies meet US-market legal requirements. Contact us for advice.
This article is general information only and does not replace legal advice for any specific case. Regulations may change; please check the current texts.
Frequently asked questions
1. What is MoCRA?
The Modernization of Cosmetics Regulation Act 2022 — modernizing US cosmetics regulation.
2. What does MoCRA require?
Mandatory facility registration + product listing with FDA, GMP, full labeling, serious adverse-event reporting.
3. What was it like before MoCRA?
FDA registration was voluntary — MoCRA made it mandatory and expanded FDA powers.
4. How does Vietnam regulate cosmetics?
Under ASEAN standards: product notification before circulation; tightening post-market checks.
5. What do US cosmetic labels need?
Full ordered ingredient lists plus adverse-event contact information.
This article has been quality-reviewed by the FLAW AI Legal Council
