MoCRA Compliance Guide for Cosmetic Brands (2026)

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) turned cosmetics into a regulated industry in the United States. Facility registration, product listings, safety substantiation, adverse event reporting — if you sell cosmetics in the U.S., these aren’t optional.

This page is the hub for everything MoCRA. Each section below gives you the essentials and links to our in-depth guide on that topic. Work through them in order and you’ll have the full picture.

1. Facility registration and product listing: the “FDA registry”

MoCRA’s two core filings, both submitted through FDA’s Cosmetics Direct portal: Facility registration (Form FDA 5066) — every facility that manufactures or processes cosmetics for U.S. distribution must register, wherever it’s located. Product listing (Form FDA 5067) — the responsible person (the name on the label) must list each marketed product with its ingredients.

There is no single “FDA registry” or “FDA cosmetic registry” — that’s the informal name for these two filings together. Facility changes must be reported within 60 days; listings update annually. Read the full guide: FDA Registry for Cosmetics: How to Register Under MoCRA (2026).

2. FEI numbers

Once FDA accepts your facility registration, your facility gets a 10-digit FDA Establishment Identifier (FEI) number — the anchor for amendments, renewals, and product listings. Read the full guide: What Is an FDA FEI Number? Not sure if your facility has one? Run our free FEI check.

3. Filing through Cosmetics Direct

All MoCRA filings go through Cosmetics Direct, FDA’s online portal. Covered step by step in our Cosmetics Direct: How to Register Your Facility Step by Step.

4. The U.S. agent requirement

Foreign facilities must designate a U.S. agent — a person or company in the United States who is FDA’s domestic point of contact. No agent, no complete registration. A proper agent monitors correspondence and handles your biennial renewal — that’s the core of what we do at US MoCRA Agent. See pricing. Already have an agent and need to switch? Read: How to Change or Transfer Your MoCRA U.S. Agent.

5. Importing cosmetics into the United States

Importers face the same MoCRA requirements with an extra layer: FDA reviews your shipment at the port, and unregistered facilities or unlisted products get detained. Read the full guide: Why Cosmetic Importers Need FDA Registration Under MoCRA (2026).

6. Selling on Amazon and marketplaces

Marketplaces like Amazon increasingly require proof of FDA registration before listings go live. Read: Amazon K-Beauty MoCRA Compliance Guide.

7. Small-business exemption

Facilities averaging under $1,000,000 in U.S. gross annual sales over the preceding 3 years may be exempt from registration and listing — unless they make eye-area products, injectables, internal-use products, or >24-hour appearance-altering products. Use our MoCRA Small Business Exemption: Free 5-Question Worksheet to check where you stand.

8. What happens if you don’t comply

Unregistered facilities and unlisted products face FDA enforcement: import detention and refusal, warning letters, and more. The full breakdown: MoCRA Non-Compliance Risks.

9. Renewals and staying compliant

Facility registrations must be renewed every two years, with the renewal date based on each facility’s initial registration date. Cosmetics Direct displays the facility’s renewal date, and FDA sends email reminders ahead of it. Renewal reminders go to the contact on file — for foreign facilities, that’s your U.S. agent’s email.

10. Adverse event reporting

Serious adverse events — death, hospitalization, significant disfigurement and more — must be reported to FDA within 15 business days, with 6-year recordkeeping for all complaints. The full requirements: MoCRA Adverse Event Reporting: What Cosmetic Brands Must Do (2026).

11. MoCRA labeling changes

MoCRA added three new label requirements: domestic contact information for adverse events, fragrance allergen disclosure, and a professional-use statement. What your labels need now: MoCRA Labeling Changes: What’s New on Cosmetic Labels (2026).

12. FDA detained your shipment

A detention notice gives you a short window to prove compliance or fix the problem — usually 14 to 21 days. The step-by-step response playbook: FDA Detained Your Cosmetic Shipment? What to Do Next

(2026).

13. Safety substantiation

Every cosmetic needs a safety file before sale — ingredient data, stability, microbial and compatibility testing. What counts as proof:MoCRA Safety Substantiation: What Counts as Proof Your Cosmetic Is Safe

(2026).

14. Selling homemade cosmetics

Home formulators and Etsy sellers face the same MoCRA rules — including a small-business exemption with sharp limits. The 2026-correct guide: Selling Homemade Cosmetics? FDA Rules Under MoCRA (2026).

Frequently asked questions

Where do I start with MoCRA compliance? Start with facility registration and product listing through Cosmetics Direct — they’re the foundation everything else builds on. See section 1 and the registry guide.

Does MoCRA apply to foreign brands? Yes. Any facility manufacturing or processing cosmetics for U.S. distribution must register, wherever it’s located — and foreign facilities must designate a U.S. agent.

How much does MoCRA compliance cost? FDA charges no fee for registration or listing. Costs are operational: your time, professional help, and ongoing U.S. agent service for foreign facilities. See pricing.

Do I need a lawyer for MoCRA? Most brands don’t need a lawyer for routine filings — but every field should be human-reviewed, and you should get written approval of filing contents before submission.

This article is for educational purposes only and is not legal advice. US MoCRA Agent is a private service provider and is not affiliated with or endorsed by the FDA. Regulatory details are based on FDA’s published guidance and are current as of September 2026; always verify requirements against FDA’s official sources before acting.