MoCRA Cosmetic Facility Registration & U.S. Agent
Professional FDA cosmetic facility registration for domestic and foreign manufacturers and processors, with U.S. Agent representation for foreign facilities and ongoing MoCRA compliance support.
Direct answer: Cosmetic facilities that manufacture or process products for the U.S. market generally must register with FDA unless an exemption applies. Required registrations are renewed every two years, changes are generally updated within 60 days, and registered foreign facilities provide a U.S. Agent. FDA uses the facility's FEI as the required registration number.
MoCRA Cosmetic Facility Registration at a Glance
The key filing rules businesses need to understand before registering a domestic or foreign cosmetic manufacturing or processing facility.
Cosmetic Facility Registration Requirements Under MoCRA
MoCRA separates the obligations of the physical manufacturing or processing facility from the product-listing obligations of the responsible person.
Domestic Cosmetic Facilities
U.S. facilities that manufacture or process cosmetic products generally must register unless an exemption applies.
- Confirm whether the site performs manufacturing or processing
- Confirm or obtain the facility FEI
- Submit facility and owner/operator information
- Maintain changes and biennial renewal
Foreign Cosmetic Facilities
Foreign facilities manufacturing or processing cosmetics for U.S. distribution may be subject to the same registration requirement and must provide U.S. Agent information when registration is required.
- Confirm FEI and physical facility data
- Designate a U.S. Agent
- Provide brand and cosmetic category information
- Maintain FDA communications and renewal
Responsible Persons / Brand Owners
The responsible person has separate product-listing and other MoCRA responsibilities even when manufacturing is performed by a contract facility.
- List marketed cosmetic products as required
- Provide listing updates annually
- Maintain safety substantiation
- Handle serious adverse-event reporting
Small-Business & Other Exemptions
Some businesses and products may qualify for exemptions, but the exclusions are specific and should be reviewed before relying on them.
- Do not assume exemption based only on company size
- Higher-risk product categories may not qualify
- Drug/device overlap can change the regulatory pathway
- Document the basis for an exemption determination
Our MoCRA Cosmetic Compliance Services
From the first facility filing through ongoing maintenance, we coordinate the pieces that need to stay aligned.
Facility Registration
Preparation and submission support for covered domestic and foreign cosmetic facilities using the required FDA facility information.
U.S. Agent Representation
U.S. Agent service for foreign cosmetic facilities that are required to register and provide U.S. Agent contact information.
FEI Coordination
Review of facility identifier status and coordination when an FEI needs to be confirmed before registration can be submitted.
Product Listing
Preparation and submission of cosmetic product listings for responsible persons, separately scoped at $200 per product.
Registration Updates & Renewal
Ongoing support for registration changes and management of the FDA-required biennial facility renewal when due.
Label & Compliance Review
Separate cosmetic label, ingredient, claims, safety-substantiation and related compliance support based on your product scope.
MoCRA Support for Cosmetic Companies Worldwide
Registration is only one part of U.S. cosmetic compliance. We coordinate filings with the broader requirements that affect market access.
Get Your Cosmetic Facility Registration Managed in 4 Steps
A clear process designed around the facility, its FEI, the foreign-facility U.S. Agent requirement, and the products associated with the site.
Confirm Scope & FEI
We review the facility role, exemption questions, FEI status and foreign-facility U.S. Agent requirement.
Collect Facility Data
We collect owner/operator, facility, brand, product-category and U.S. Agent information needed for the registration.
Prepare & Submit
We prepare the registration for submission through the applicable FDA registration and listing system.
Maintain Compliance
We support changes, FDA communications, U.S. Agent representation and biennial renewal management when due.
The FDA Rules Behind MoCRA Facility Registration
The page is built around the current statutory and FDA submission framework—not outdated annual-renewal language.
FD&C Act § 607
MoCRA added section 607 requirements governing cosmetic facility registration and cosmetic product listing, including biennial facility renewal and annual product-listing updates.
Form FDA 5066
FDA Form 5066 is the facility registration form and includes initial registration, amendments, cancellation, biennial renewal and abbreviated renewal document types.
Cosmetics Direct
FDA Cosmetics Direct is the electronic submission portal and SPL authoring tool used for cosmetic facility registration and product listing submissions.
Core MoCRA Responsibilities Beyond Facility Registration
Facility registration does not replace the product, safety, labeling and post-market obligations that can apply to cosmetic companies.
Product Listing
The responsible person lists each marketed cosmetic product as required and provides listing updates annually.
Safety Substantiation
The responsible person must ensure and maintain adequate substantiation of cosmetic product safety.
Serious Adverse Events
Serious adverse events associated with cosmetic products in the United States must be reported to FDA within 15 business days.
GMP Rulemaking
MoCRA directs FDA to establish cosmetic GMP regulations. Companies should distinguish current statutory duties from FDA's still-developing final cosmetic GMP rulemaking.
MoCRA Facility Registration vs. Cosmetic Product Listing
These filings work together, but the responsible party, filing content, update cycle and purpose are different.
| Criteria | Facility Registration | Product Listing |
|---|---|---|
| Who Files | Owner/operator of a covered manufacturing or processing facility | Responsible person whose name appears on the cosmetic label |
| FDA Form | Form FDA 5066 | Form FDA 5067 |
| Identifier | FEI used as the facility registration number | FDA product-listing record associated with the responsible person and facility information |
| Routine Cycle | Renew every two years; update registration changes as required | Provide updates annually |
| Foreign U.S. Agent | Required information for foreign facilities that must register | Not a separate U.S. Agent requirement merely because the responsible person is foreign |
| Our Fee | $849/year professional service | $200/product |
Self-Filing vs. FDA Registration Assistance
Businesses can file directly with FDA, but the practical challenge is keeping the facility, FEI, responsible-person data, product listings and renewal cycles aligned.
| Area | DIY Self-Filing | FDA Registration Assistance |
|---|---|---|
| Scope Review | You determine whether the facility is covered and whether an exemption applies. | We review the business role, facility activities and filing scope before submission. |
| FEI | You confirm the correct FEI and facility identity. | We coordinate the FEI and registration details before filing. |
| Foreign Facility | You arrange and maintain the required U.S. Agent information. | U.S. Agent representation is included for covered foreign facilities. |
| Renewal | You track the facility's two-year renewal date and updates. | We manage ongoing updates and the biennial FDA renewal when it comes due. |
| Product Listings | You separately maintain Form 5067 product listings and annual updates. | We can manage listings alongside the facility record so the information stays coordinated. |
Common MoCRA Registration & Listing Mistakes
Most avoidable problems come from treating MoCRA as a one-time certificate instead of an ongoing registration, listing and records framework.
FDA uses FEI as the required cosmetic facility registration number.
Facility registration renewal is biennial, while product listing updates are annual.
FDA registration or listing is not product approval, clearance, endorsement or certification.
A foreign facility that must register needs to provide the required U.S. Agent information.
A registered facility does not eliminate the responsible person's separate product-listing obligations.
Marketplace requirements can change; the legal obligation should be determined from FDA rules and the business/product facts.
Frequently Asked Questions About MoCRA Cosmetic Registration
Current answers covering facility registration, product listing, FEI, U.S. Agent requirements, renewal cycles and ongoing cosmetic compliance.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) expanded FDA authority over cosmetics and established new industry requirements including cosmetic facility registration, cosmetic product listing, serious adverse event reporting, safety substantiation, and other compliance obligations.
Owners or operators of facilities that manufacture or process cosmetic products distributed in the United States generally must register the facility with FDA unless an exemption applies. The requirement can apply to both domestic and foreign facilities.
Required cosmetic facility registrations are renewed every two years. This is a biennial FDA renewal requirement under section 607(a)(2) of the FD&C Act.
Required changes to facility registration information generally must be submitted within 60 days after the change.
Yes. A foreign cosmetic facility that is required to register must provide U.S. Agent contact information as part of its facility registration.
FDA uses the FDA Establishment Identifier (FEI) as the required facility registration number. An owner or operator should obtain or confirm the facility FEI before submitting the registration.
No. FDA uses the FEI as the required facility registration number for cosmetic facilities. A DUNS number should not be presented as the MoCRA facility registration number.
FDA Form 5066 is the paper form for cosmetic product facility registration. Electronic submissions can be made through FDA Cosmetics Direct.
Cosmetics Direct is FDA's electronic submission portal and SPL authoring tool for cosmetic facility registrations and cosmetic product listings.
No. Facility registration identifies a manufacturing or processing facility. Cosmetic product listing is a separate requirement submitted by the responsible person for marketed cosmetic products.
The responsible person is the manufacturer, packer, or distributor whose name appears on the cosmetic product label in accordance with the applicable FD&C Act or Fair Packaging and Labeling Act provisions.
The responsible person must provide updates to cosmetic product listings annually. FDA Form 5067 includes annual update and abbreviated renewal document types.
FDA Form 5067 is the paper form for cosmetic product listing. Listings can also be submitted electronically through Cosmetics Direct.
No. FDA states that cosmetic facility registration and cosmetic product listing are not approval programs and that FDA does not issue certificates for cosmetic facility registrations or product listings. We provide clients with their submission and filing records.
No. Facility registration or product listing does not mean FDA has approved, cleared, endorsed, or certified the cosmetic product.
Some small businesses may qualify for exemptions from facility registration and product listing, but the exemption does not apply to certain categories of higher-risk cosmetic products. Eligibility should be evaluated based on the specific business and products.
Yes. A responsible person must ensure and maintain records supporting adequate safety substantiation for cosmetic products.
A responsible person must report serious adverse events associated with cosmetic products in the United States to FDA within 15 business days and comply with the applicable recordkeeping requirements.
MoCRA requires FDA to establish cosmetic GMP regulations. FDA currently provides draft cosmetic GMP guidance and continues the rulemaking process, so companies should distinguish current statutory obligations from future final GMP regulations.
FDA allows a single cosmetic product listing submission to include multiple products with identical formulations, or formulations that differ only in colors, fragrances or flavors, or quantity of contents, when the applicable FDA conditions are met.
Typical information includes the facility legal name and physical address, owner or operator information, facility email and phone, FEI number, cosmetic product categories and brand names manufactured or processed at the facility, and U.S. Agent information for a foreign facility.
Failure to meet an applicable MoCRA registration or listing requirement can create compliance and enforcement risk. FDA also has authority to suspend a facility registration in specified serious circumstances under MoCRA.
Yes. FDA Registration Assistance can provide U.S. Agent representation for foreign cosmetic facilities and support FDA communications associated with the registered facility.
The $849 annual professional service includes cosmetic facility registration management, U.S. Agent representation for foreign facilities when required, FDA correspondence support, registration updates, and biennial FDA renewal management when the facility renewal comes due. Product listings and separately scoped services are additional.
FDA Registration Assistance charges $200 per cosmetic product listing. Multi-product portfolios can be scoped based on the number of products and the complexity of the listings.
Preparation and submission timing depends on whether the facility already has a valid FEI and whether all required information is available. Many complete matters can be prepared within a few business days, but FDA processing or identifier issues can affect timing.
A contract manufacturer or processor may need to register the physical cosmetic manufacturing or processing facility unless an exemption applies. Brand owners should confirm that the facilities associated with their products are properly addressed in their product listings.
A responsible person whose name appears on the cosmetic label may have product listing responsibilities even when manufacturing is performed by a contract facility. The exact filing structure depends on the label, responsible person, facility, and product arrangement.
No special MoCRA exemption exists merely because a cosmetic is sold online. The applicable facility registration, product listing, labeling, safety, and adverse-event obligations depend on the business and product, not simply the sales channel.
Yes. FDA Registration Assistance can coordinate the facility registration, foreign-facility U.S. Agent designation, product listings, listing updates, and related cosmetic compliance work as one managed project.
Ready to Register Your Cosmetic Facility?
Send us your facility and product details. We’ll review the scope and confirm the filings and supporting services that apply.
Prefer to speak with us? Call 928-275-8333 or email info@fdaregistrationassistance.com.