MoCRA Facility Registration and Product Listing: What Brands Must Do

Spectra Cosmetic Compliance

These requirements sit within the wider MoCRA framework. Confirm current detail with the FDA as guidance evolves.

Facility registration: who must register

Under MoCRA any facility that manufactures or processes cosmetic products for the US market must register with the FDA. This applies to both domestic and foreign facilities a factory outside the US making cosmetics for US sale must register the same as a US based facility. Registration with the FDA is one of the most fundamental obligations the Modernization of Cosmetics Regulation Act introduced for cosmetic manufacturers.

The registration requirement was added to the Federal Food Drug and Cosmetic Act (FD&C Act) as Section 607 and it applies to the facility itself not the brand not the distributor. Facilities operating as of December 29 / 2022 had to register by July 1 2024 new facilities must register within 60 days of starting production.

Why this matters for international brands

If your products are made abroad for the US market your manufacturing facility generally needs to be FDA Registered not just your US facing business. This is one of the first compliance steps to check with your supply chain which facility actually manufactures or processes the product and is it registered? Meeting the facility registration requirements is not optional simply because a facility sits outside the US.

What is a MoCRA US Agent?

A foreign facility registering under MoCRA must designate a US Agent a person or business physically located in the United States who acts as the facility's official point of contact with the FDA. Registration cannot be completed in the FDA's Facility Registration and Product Listing (FURLS/CRL) system without one.

Per FDA guidance the US Agent must reside in the US or maintain a US place of business and be physically present in the country a mailbox or answering service alone doesn't qualify.

What does the US Agent do?

The US Agent:

• Serves as the FDA's point of contact for the foreign facility
• Receives and relays FDA communications
• Assists during FDA inspections and information requests

The US Agent is not your importer distributor or regulatory consultant by default though some brands do combine these roles for convenience.

How is this different from the EU/UK Responsible Person?

Arranging a US Agent is one of several ways MoCRA requires international brands to establish a US facing compliance presence conceptually similar in purpose to the EU Responsible Person under Regulation (EC) No 1223/2009 or the UK Responsible Person under the Cosmetic Products Enforcement Regulations 2013 but structured differently the US Agent's role is narrower (FDA point of contact) than the broader compliance and safety file responsibilities the EU/UK Responsible Person carries.

Renewing and updating registration

Facility registration is not a one off. It must be renewed every two years (biennially) and updated within 60 days of significant changes such as changes to the facility's ownership location or contact details. Keeping registration current is an ongoing obligation and the FDA has built renewal reminders and status information into its systems.

This means facility registration is a live record that brands must maintain not a box ticked once. Missing a renewal or failing to update a change leaves the registration out of date and the facility potentially non compliant. Tracking renewal dates is part of ongoing MoCRA compliance and helps a brand monitor compliance across its whole supply chain rather than just at the point of initial registration.

Product listing: what must be listed

Separately from facility registration the responsible person must submit a product listing for each marketed cosmetic product. The listing includes information about the product including its ingredients and generally references the registration number of the facility where the product is made. Listings must be updated annually.

Product listing must be done for each product including those provided as free samples or gifts, unless an exemption applies. This gives the FDA a comprehensive picture of the cosmetic products in the United States market and their ingredients information it uses to identify potential risks and facilitate recalls.

How to submit: Cosmetics Direct

The FDA provides an electronic portal Cosmetics Direct for submitting facility registrations and product listings. There are alternative methods, including certain electronic submissions and paper forms but Cosmetics Direct is the FDA's dedicated online system designed to streamline the process. Registrations and listings are submitted through these channels rather than on paper by default.

Using the FDA's systems correctly providing the required information accurately and in the right format is part of doing this properly. Errors or omissions in a registration or listing can cause problems so care in the submission is worthwhile. There is no fee to register or list under MoCRA.

The small business exemption

Certain small businesses are exempt from the facility registration and product listing requirements based on average gross annual cosmetic sales below a defined threshold. This provides relief for the smallest businesses. However the exemption is limited and does not apply to certain higher risk products including those that regularly contact the mucous membrane of the eye are injected are intended for internal use or alter appearance for more than 24 hours.

So even a small business must register and list for those higher Risk product types. Brands relying on the exemption should confirm both that they meet the sales threshold and that their products are not in the excluded categories. The exemption is narrower than it first appears.

Why this matters: enforcement

Facility registration and product listing are the foundation of the FDA's MoCRA oversight the information it uses to know what is on the market and to act on risks. The FDA has been actively enforcing these requirements and analyses have found significant non compliance among imported cosmetics in particular. Non compliant products risk enforcement action. This is exactly why cosmetic facility registration is treated as a genuine legal obligation and not a formality.

For brands, this means registration and listing are not optional paperwork but a genuine, enforced requirement. Getting them done and keeping them current through renewals and updates is essential to selling cosmetics compliantly in the US. It is often the first thing to address when entering the market and mandatory facility registration in particular should be confirmed before any product ships.

Facility registration vs. product listing: what's the difference?

Facility registration covers the place the site that manufactures or processes cosmetics for the US market.

Product listing covers the product each individual cosmetic sold, submitted separately from the facility record.

These are two separate submissions under MoCRA each with its own deadlines and obligations.

A product listing generally references its facility's registration number so both records need to exist and stay linked.

Who handles what when using a contract manufacturer?

The manufacturing facility (often a third party contract manufacturer) is generally the party that must complete facility registration with the FDA.

The Responsible Person the brand named on the product label per Section 609(a) of the FD&C Act handles the product listing.

Brands that don't manufacture in house need active coordination with their contract manufacturer to confirm both sides are actually filed one obligation doesn't cover the other.

How often do these need renewing?

Facility registration: renew every 2 years update within 60 days of any significant change (ownership address product categories etc.).

Product listings: update annually and again whenever a listed product changes.

MoCRA compliance is not a one time market entry task it's an ongoing obligation and letting either registration or listing lapse is itself a compliance gap not just an administrative oversight.

Does the small business exemption apply to you?

The exemption, under Section 612 of MoCRA covers businesses with average gross annual US cosmetic sales under $1 million over the prior three years.

It does not apply if your products fall into FDA's excluded higher Risk categories, regardless of revenue:

• Products that regularly contact the mucous membrane of the eye
• Injected products
• Products intended for internal use
• Products intended to alter appearance for more than 24 hours where consumer removal isn't customary

Even exempt small businesses still must handle adverse event reporting and safety substantiation the exemption only removes facility registration and product listing, not every MoCRA obligation.

Brands sometimes assume they qualify without checking both conditions (revenue and product category) confirming exemption status rather than assuming it avoids an unwelcome discovery later. When in doubt registering and listing is the safer course.

References: MoCRA (FD&C Act cosmetics provisions) FDA guidance on cosmetic facility registration and product listing FDA Cosmetics Direct. Verified July 2026 confirm current FDA detail before acting. General information only not legal advice.