FDA MoCRA for Cosmetics: Complete Guide 2026

MoCRA (Modernization of Cosmetics Regulation Act of 2022) is the biggest change to US cosmetics regulation in 80 years. If you sell cosmetics in the US, you need to understand it. Here's what you need to know.

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What is MoCRA?

MoCRA gives the FDA authority to regulate cosmetics more strictly. Before MoCRA, cosmetics were essentially self-regulated. Now the FDA can:

• Require facility registration
• Require product listing
• Recall unsafe products
• Set good manufacturing practice standards

Who Needs to Comply?

If your cosmetics are sold in the US (online or in stores), you need:

• Facility Registration: Every manufacturing facility must register with FDA
• Product Listing: Every product SKU must be listed
• US Agent / Responsible Person: Foreign manufacturers must designate a US-based contact

Key Requirements Summary

Requirement	Who Handles It
Facility registration	Manufacturer
Product listing	Brand owner / manufacturer
US Agent	Brand owner (if foreign)
Safety substantiation	Brand owner / manufacturer
Adverse event reporting	Brand owner

What This Means for Your Brand

If you work with a GMPC-certified manufacturer like us, they already handle facility registration. But you as the brand owner are responsible for:

• Product listing (each SKU must be listed)
• Designating a US Agent if you're outside the US
• Maintaining safety substantiation records
• Reporting adverse events

Related Guides

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Cosmetics Testing & Certification

Safety testing requirements by market.

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The Penalty Reality: Why This Isn't Optional

MoCRA gives the FDA mandatory recall authority and facility-suspension powers. For an importer, the practical risks are concrete: marketplace takedowns (Amazon requires MoCRA facility registration numbers for cosmetics categories), customs holds on unregistered goods, and — worst case — a mandatory recall whose cost lands entirely on the brand. Registration is a few hundred dollars of effort protecting tens of thousands of dollars of inventory.

Your MoCRA Paper Trail in One List

• Facility registration number (our FDA-registered facility's number goes on your records)
• Product listing per SKU with the responsible person's US contact
• Safety substantiation file (formulation, stability, micro, contaminant data)
• Adverse event contact and log procedure
• Label files meeting labeling requirements (US agent listed where applicable)

Adverse Events: The 15-Business-Day Clock

Under section 605 of the FD&C Act (21 U.S.C. § 364a), the responsible person must send FDA a serious adverse event report — with a copy of the label as it appears on or within the retail packaging — no later than 15 business days after receiving the report. The clock starts when you receive the report, not when the reaction happened.

• New medical information: New and material medical information about a reported event, received within 1 year of the initial report, must also reach FDA within 15 business days.
• Record retention: Keep records for each adverse event report for 6 years — 3 years for a qualifying small business.
• Fragrance and flavor requests: If FDA has reasonable grounds to believe an ingredient or combination contributed to a serious adverse event, it may request the fragrance or flavor ingredient list in writing; the response is due within 30 days.
• Non-serious events: Reporting these is voluntary under MoCRA — the mandate covers serious adverse events only.

"Serious" is defined by outcome, not by how alarming the report sounds. It covers death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, significant disfigurement — or an event requiring medical or surgical intervention to prevent any of those outcomes.

Who Is the 'Responsible Person' — and Why It's You

Under MoCRA, the responsible person is the manufacturer, packer or distributor whose name appears on the label — and for imported cosmetics, that is typically the US brand owner, not the Chinese factory. The responsible person owns: product listing, safety substantiation, adverse event handling, and record retention. Your factory supports with documents; the legal accountability sits stateside. This is why the factory being FDA-registered helps, but does not replace your filings.

Registration Step by Step

1. Create a FDA Industry Systems (FURLS) account for your company
2. Register the manufacturing facility — use your factory's FDA facility registration number
3. Submit product listings per SKU: product category, INCI list, responsible person, label images
4. Assign a US contact for adverse event reporting (your address or a service)
5. Build the safety substantiation file and keep it retrievable for FDA requests
6. Update listings when formulations or labels change — amendments matter

Factory Docs vs Your Filings: Who Does What

Fragrance Allergens and Labeling: The Quiet MoCRA Update

MoCRA's rulemaking wave includes fragrance allergen labeling alignment with international norms. If your product contains fragrance, assume future labels must declare a defined allergen list — the same direction the EU already took. Practical move: ask your factory for the full allergen declaration now, and design your label artwork with a flexible ingredient-declaration zone so a future update does not force a full redesign.

Small Importer Exemptions: Read the Fine Print

Certain exemptions exist for very small businesses — but they are narrower than most first-time importers assume: they can cover some recordkeeping and registration duties for the smallest firms, yet product safety substantiation and labeling obligations generally still apply, and exemptions have revenue thresholds and product-type carve-outs (eye-area, injectable, and some other categories never qualify). If your growth plan involves retail or marketplaces, assume you need the full file — exemptions rarely survive your first retail onboarding questionnaire.