FDA Cosmetic Facility Registration Guide: MoCRA Requirements & Process

What is FDA Cosmetic Facility Registration?

Under the Modernization of Cosmetics Regulation Act (MoCRA), cosmetic product facilities that manufacture or process cosmetics for distribution in the United States must register with the FDA. This is a fundamental change from the previous voluntary registration system.

Historical Context

Before MoCRA, the FDA operated a Voluntary Cosmetic Registration Program (VCRP). MoCRA replaced this with mandatory registration requirements, bringing US cosmetics oversight closer to regulatory frameworks in other major markets.

According to 21 U.S.C. § 364c, facility registration is now a legal requirement, not a voluntary option. Failure to register can result in FDA enforcement action, including import alerts for foreign facilities.

Who Must Register a Facility?

Facilities Required to Register

Based on FDA registration guidance, the following facilities must register:

Facility Registration Requirements by Type
Facility Type	Registration Required	Notes
US Manufacturing Facilities	Yes	All facilities that manufacture or process cosmetics
US Contract Manufacturers	Yes	Even if manufacturing for other brands
Foreign Manufacturing Facilities	Yes	If exporting cosmetics to the US
US Packaging/Labeling Facilities	Depends	Filling containers = Yes; Pure relabeling/repackaging = No
Warehouses (storage only)	No	Storage and distribution only — no processing
Testing Laboratories	No	Unless manufacturing occurs
Retailers (store only)	No	Unless they manufacture private label

Source: FDA Registration Guidance

Small Business Exemption

Under 21 U.S.C. § 364h, certain small businesses may be exempt from facility registration requirements:

Small Business Exemption Criteria

To qualify for the exemption, your business must have less than $1 million in average annual gross sales of cosmetic products over the previous 3-year period. Exemption does NOT apply if you manufacture: 1. Products regularly contacting mucous membrane of the eye (mascara, liquid eyeliner, eyelash adhesive) 2. Injectable cosmetic products 3. Products intended for internal use 4. Products altering appearance for more than 24 hours when removal is not customary (permanent hair dyes, gel nails, acrylic nails) Note: Drug-cosmetic combination products are handled under separate provisions (Section 613 FD&C Act).

Per FDA Guidance for Industry (December 2024) and Section 612 of the FD&C Act:

Small Business Exemptions Include:

Facility registration — EXEMPT
Product listing — EXEMPT
GMP compliance — EXEMPT (when finalized)
Adverse event record retention — REDUCED to 3 years (vs. 6 years)

Small businesses must still comply with:

Labeling requirements
Adverse event reporting (15 business days for serious events)
Safety substantiation
Prohibited ingredient restrictions
Products must not be adulterated or misbranded

Registration Requirements

Information Required for Registration

Based on FDA Form 5066, you must provide:

Required Registration Information

Facility name and physical address (not a P.O. Box)
Facility Establishment Identifier (FEI) if previously assigned
Contact person name, phone number, and email
Parent company information (if applicable)
Cosmetic product categories manufactured at the facility
US Agent information (for foreign facilities)
Dunn and Bradstreet (DUNS) number (optional but recommended)

Facility Establishment Identifier (FEI)

According to FDA's FEI Portal, each facility receives a unique FEI number upon registration. If you previously registered with FDA for drugs, devices, or other products, you may already have an FEI assigned.

Finding Your FEI

Use the FDA's FEI Search Portal to check if your facility already has an FEI number from previous registrations. Using your existing FEI ensures consistency across all FDA programs.

Step-by-Step Registration Process

How to Register Your Facility

Create FDA Industry Systems Account

Visit FDA's Industry Systems portal and create an account if you don't have one. You'll need a valid email address and company information. Foreign facilities should also designate a US Agent at this stage.

Access Cosmetics Direct

Log into FDA's Cosmetics Direct portal at direct.fda.gov using your Industry Systems credentials. This is the official electronic submission system launched in December 2023.

Select 'Facility Registration'

From the Cosmetics Direct dashboard, select the option to register a new facility. If updating an existing registration, select 'Update Registration' instead.

Enter Facility Information

Complete all required fields including facility name, address, contact information, and product categories. For foreign facilities, enter US Agent details.

Review and Submit

Review all entered information for accuracy. Once submitted, you'll receive a confirmation with your facility registration number.

Save Confirmation

Download and save your registration confirmation. You'll need this for records and may need to provide it to business partners or customs officials.

Alternative Submission Methods

While Cosmetics Direct is the primary method, FDA also accepts:

SPL (Structured Product Labeling) submissions via the FDA ESG (Electronic Submissions Gateway) per FDA SPL guidance
Paper submissions using FDA Form 5066 (not recommended due to processing delays)

Electronic Submission Recommended

FDA strongly encourages electronic submission through Cosmetics Direct. Paper submissions may experience significant processing delays and are more prone to errors.

Registration Deadlines

According to FDA deadline announcements:

FDA Facility Registration Deadlines
Scenario	Deadline	Status
Facilities operating before Dec 29, 2022	December 29, 2023	Passed
New facilities beginning after Dec 29, 2022	Within 60 days of beginning operations	Ongoing
Biennial renewal	Every 2 years	Ongoing
Updates to registration	Within 60 days of changes	Ongoing

Source: FDA MoCRA Implementation

Biennial Renewal Requirements

Per FDA Guidance for Industry (December 2024), facility registrations must be renewed biennially (every 2 years):

Renewal frequency: Every 2 years
Action required: Verify and update all registration information
Updates: Required within 60 days of any material changes to facility information
Consequence of non-renewal: Registration may become inactive

Common Registration Mistakes

Avoid These Common Errors

Based on FDA compliance reports and industry feedback, these are the most common facility registration mistakes:

Common Mistakes to Avoid

Using a P.O. Box instead of physical facility address
Not updating registration within 60 days of changes
Foreign facilities failing to designate a US Agent
Registering the wrong entity (brand owner vs. manufacturer)
Forgetting to renew registration biennially
Listing incorrect product categories
Not saving registration confirmation for records

Registration vs. Product Listing

It's important to understand the difference between facility registration and product listing:

Registration vs. Listing
Aspect	Facility Registration	Product Listing
What it covers	Manufacturing/processing location	Individual cosmetic products
Who submits	Facility owner/operator	Responsible person (often brand owner)
Deadline for new	60 days of beginning operations	120 days of market entry
Renewal	Yes (biennial)	No (update as needed)
Small business exemption	Partial	No exemption

Source: FDA Cosmetics Direct

Compliance Status & Enforcement

As of 2026, FDA compliance programs are actively monitoring facility registration:

FDA has begun sending warning letters to unregistered facilities
Import alerts may be issued for products from unregistered foreign facilities
Unregistered facilities may face inspection prioritization

Enforcement Active

FDA enforcement of MoCRA registration requirements is now active. If your facility is not registered, take immediate action to comply and avoid regulatory consequences.

Resources for Registration

According to FDA submission tools announcements, these resources are available:

Cosmetics Direct Portal: direct.fda.gov
FDA Industry Systems: For account creation
SPL Implementation Guide: For technical submissions
FDA Help Desk: For registration assistance

Next Steps After Registration

Once your facility is registered, you should:

1. List your products - See our MoCRA Product Listing Guide 2. Designate a responsible person - See MoCRA Responsible Person Requirements 3. Establish adverse event procedures - Required for all registered facilities 4. Calendar biennial renewal - Set reminders for every 2 years

Facility registration is mandatory under MoCRA for all cosmetic manufacturers and processors

Use FDA's Cosmetics Direct portal for electronic registration submission

Initial registration deadline has passed - register immediately if not done

Biennial renewal required (every 2 years)

Foreign facilities must designate a US Agent

Small business exemption available but limited in scope

Need Help with Facility Registration?

Our regulatory specialists can guide you through the FDA facility registration process and ensure full MoCRA compliance.

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Frequently Asked Questions

FDA cosmetic facility registration is a mandatory requirement under MoCRA where facilities that manufacture, process, or pack cosmetics for US distribution must register with the FDA through the Cosmetics Direct portal. This replaced the previous voluntary registration program.

Create an FDA Industry Systems account, then access the Cosmetics Direct portal at direct.fda.gov. Complete the facility registration form with your facility information, product categories, and contact details. For foreign facilities, you must also designate a US Agent.

For existing facilities, the deadline was December 29, 2023. New facilities must register within 60 days of beginning operations. All registrations must be renewed biennially (every 2 years). Updates must be submitted within 60 days of any material changes to facility information.

Small businesses with less than $1 million in average annual gross cosmetic sales may be exempt from facility registration AND product listing. However, the exemption doesn't apply if you manufacture high-risk products (eye-area cosmetics, injectables, internal-use products, or long-lasting appearance-altering products). Even exempt businesses must still report serious adverse events within 15 business days and comply with labeling and safety substantiation requirements.

Failure to register can result in FDA enforcement action including warning letters, import alerts (for foreign facilities), and inspection prioritization. Your products may be considered misbranded if manufactured at an unregistered facility.