Direct answer: MoCRA registration usually means two filings: cosmetic facility registration for the place where products are manufactured or processed, and product listing for the cosmetic products marketed in the United States. Foreign facilities that must register need a U.S. Agent. Facility registration renews every two years, while product listings require annual updates. MoCRA registration is now one of the core compliance steps for cosmetic brands that sell, manufacture, process, or distribute cosmetic products in the U.S. market. The Modernization of Cosmetics Regulation Act of 2022, known as MoCRA, changed cosmetics from a mostly voluntary registration model to a mandatory facility registration and product listing system for many companies. FDA describes MoCRA as the most significant expansion of its authority over cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938. The practical result is simple: many cosmetic companies now need to know where products are made, which products are listed, who is responsible for the label, and how the records will be maintained over time. The key deadline many brands remember is Dec. 29, 2023. That was the original statutory deadline for existing facilities and marketed products under MoCRA. FDA later announced enforcement discretion until July 1, 2024, but the business reality remains the same: cosmetic companies selling in the U.S. market should treat MoCRA registration as an active compliance requirement, not a future project. For most cosmetic companies, the process has two main filings and one renewal calendar to manage. First, cosmetic facilities that manufacture or process products for U.S. distribution may need facility registration. Second, the Responsible Person may need to submit product listings for marketed cosmetic products. Third, facility registration must be renewed every two years, while product listings require annual updates and careful review when product data changes. I’m Gustavo Zapata, Co-founder of REGISTRO-FDA.US in Miami. We help international companies prepare FDA-related submissions, coordinate U.S. Agent service, and reduce avoidable mistakes before products reach U.S. retailers, importers, or marketplaces. In this guide, we explain MoCRA registration in plain English, including who must register, what documents you need, how FEI differs from DUNS, how U.S. Agent service works, what FDA does and does not issue, and how to avoid the most common mistakes.
What Is MoCRA?
Regulation in Plain English
MoCRA stands for the Modernization of Cosmetics Regulation Act of 2022. It is a U.S. law that gave FDA new authority over cosmetic products distributed in the United States. Before MoCRA, many cosmetic companies used FDA’s Voluntary Cosmetic Registration Program, known as VCRP. That system was voluntary. FDA stopped accepting VCRP submissions in 2023 while it developed the new system for mandatory facility registration and product listing under MoCRA. Old VCRP participation does not equal MoCRA registration. A simple way to understand MoCRA registration is this: MoCRA registration tells FDA where cosmetic products are made or processed, what products are marketed, and who is responsible for those products. This does not mean FDA approves cosmetic products before sale. It also does not mean FDA issues a MoCRA certificate. FDA states that cosmetic product facility registration and product listing are not an approval program or a promotional tool, and FDA does not issue certificates for these submissions.
What Changed vs. the pre-MoCRA Cosmetic Landscape
Before MoCRA, many cosmetic companies had fewer federal filing obligations than food, drugs, or medical devices. Businesses still had to sell safe and properly labeled products, but facility registration and product listing were not mandatory for most ordinary cosmetic products. MoCRA changed that structure. Now, many manufacturers and processors must register facilities with FDA. Responsible Persons must list marketed cosmetic products, including product ingredients. FDA can also access certain records, receive serious adverse event reports, and use expanded recall authority in specific safety situations. For cosmetic brands, this creates a more formal compliance process. It also creates more questions:
- Do I need cosmetic facility registration?
- Do I need product listing?
- Do I need a U.S. Agent?
- Do I need an FEI number?
- Is DUNS required?
- How often do I renew?
- What proof can I show a retailer or importer?
This guide answers those questions.
Why MoCRA Exists
MoCRA exists to improve consumer safety, ingredient visibility, and FDA oversight of the cosmetic market. FDA notes that people use many cosmetic products daily, including makeup, nail products, shaving products, perfumes, cleansers, haircare products, moisturizers, and other skincare products. For international brands, MoCRA registration also creates a clearer compliance record. A U.S. importer, Amazon seller, distributor, or retailer may ask whether your facility is registered, whether your products are listed, and whether your company has a U.S. contact for FDA communications.
💡 Tip: MoCRA moves cosmetics closer to the registration-and-listing model used in other FDA-regulated product areas. It does not make cosmetics “FDA approved,” but it does make compliance more structured.
Who Must Register Under MoCRA?
MoCRA registration depends on the role your company plays in the cosmetic supply chain. The most important question is not only “Do I sell cosmetics?” It is also “Do I manufacture, process, pack, distribute, import, or place my name on the product label?”
Manufacturers and Processors
FDA guidance explains that every person who owns or operates a facility that manufactures or processes a cosmetic product for distribution in the United States must evaluate facility registration obligations. A facility may include an establishment that manufactures or processes cosmetic products distributed in the United States. Manufacturing or processing can include steps in making a cosmetic product by chemical, physical, biological, or other procedures. It can also include manipulation, sampling, testing, or control procedures. This is why a company should not look only at the finished label. It should also look at the activities performed at each site. Examples of facilities that may need cosmetic facility registration include:
- A skincare factory making creams for U.S. sale.
- A shampoo manufacturer filling finished product containers.
- A contract manufacturer producing cosmetics for multiple brands.
- A laboratory that performs batch release testing as part of manufacturing or processing.
- A facility outside the U.S. that manufactures cosmetics later imported into the U.S.
Some locations may not fall within the facility definition if they only perform limited commercial or distribution activities. For example, a location that only stores finished goods is different from a location that fills product into containers. The activity matters.
Brand Owners and Responsible Persons
MoCRA also uses the term “Responsible Person.” FDA defines the Responsible Person as the manufacturer, packer, or distributor whose name appears on the cosmetic product label under applicable labeling law. For many private-label brands, the Responsible Person is the brand company named on the label, even if a contract manufacturer makes the product. The Responsible Person is important because product listing is tied to that role. For each cosmetic product, the Responsible Person must submit a cosmetic product listing or ensure that the listing is submitted. This is one of the most important role distinctions in MoCRA registration. A contract manufacturer may own or operate the facility. The brand may be the Responsible Person. An importer may move the goods. A U.S. Agent may serve as the FDA contact for a foreign facility. Those are not the same role.
Foreign vs. Domestic Facilities
A domestic facility is located in the United States. A foreign facility is located outside the United States and manufactures or processes cosmetic products distributed in the U.S. market. Foreign facilities have an extra step: they must identify a U.S. Agent for registration purposes. FDA guidance states that, for a foreign facility, the facility registration must include U.S. Agent contact information. It also states that a U.S. Agent must reside in the U.S. or maintain a U.S. place of business and be physically present in the U.S. This requirement matters for brands and manufacturers in Europe, Latin America, the Middle East, Asia, and other regions. If your facility is outside the United States and your products are sold in the U.S. market, U.S. Agent planning should happen before the submission.
Edge Cases
Some cases require careful review. Contract manufacturers. If a facility manufactures products for many brands, only one registration may be required for that facility. A Responsible Person whose products are manufactured or processed at the facility may submit the facility registration for that facility. Drop-shipping brands. A brand that only sells online may still be the Responsible Person if its name appears on the label. It may not own the manufacturing facility, but it may still need product listings. Importers. Some importers may be involved with facilities or distribution but may not always be the Responsible Person. The label and business role must be reviewed. Relabeling or repackaging. FDA guidance distinguishes between certain labeling, relabeling, packaging, repackaging, holding, or distribution activities and manufacturing or processing. Filling a product container with cosmetic product is different from merely handling a finished item. Products that are both drugs and cosmetics. Some products may be regulated as both drugs and cosmetics. Sunscreens, acne products, dandruff shampoos, and antiperspirants can create special review needs. A company should not submit a MoCRA filing until it understands whether the product is only a cosmetic or also subject to drug requirements.
Facility Registration vs. Product Listing — Two Required Filings
MoCRA registration is easier when you separate the two main filings.
Facility Registration: the “where”
Facility registration answers the “where” question. It identifies the physical facility that manufactures or processes cosmetic products for distribution in the United States. It includes information such as the owner or operator, facility name, address, contact information, brand names, product categories, responsible persons, submission type, and U.S. Agent information for foreign facilities. FDA intends to use the FDA Establishment Identifier, or FEI, as the required facility registration number. The owner or operator will need to obtain an FEI number before submitting facility registration.
Product Listing: the “what”
Product listing answers the “what” question. It identifies each marketed cosmetic product, the applicable product category, ingredients, the Responsible Person, and the facility registration number for each facility where the product is manufactured or processed. A single listing may include multiple cosmetic products with identical formulations or formulations that differ only by colors, fragrances, flavors, or quantity of contents. Product listing is not the same as facility registration. A company may have one facility registration but many product listings.
How FEI Ties Them Together
FEI stands for FDA Establishment Identifier. It is a unique identifier assigned by FDA to identify firms associated with FDA-regulated products. FDA intends to use the FEI as the cosmetic product facility’s registration number. In practice, FEI connects the facility profile to the product listing. Product listings need the facility registration number for each facility where the cosmetic product is manufactured or processed.
FEI vs. DUNS
This is one of the biggest MoCRA registration mistakes. FEI is the FDA Establishment Identifier. It is the FDA identifier used for the facility registration number. DUNS is a commercial identifier from Dun & Bradstreet. DUNS stands for Data Universal Numbering System. It is a site-specific commercial business identifier. DUNS may appear in business, logistics, importer, or retailer workflows. But it is not the same as FEI.
⚠️ Note: Importers, retailers, distributors, or marketplaces may ask for your DUNS. That is a commercial or logistics request. For MoCRA facility registration, FEI is the FDA identifier.
Required Documents and Information
A smooth MoCRA registration process starts before you log into the portal. The biggest delays usually come from missing facility data, unclear label responsibility, ingredient names that are not ready, or incomplete product labels.
For a deeper side-by-side comparison of facility registration vs product listing, see our Product Listing vs Facility Registration filing guide.
For Facility Registration
For facility registration, prepare:
- Legal name of the owner or operator.
- Facility name and physical address.
- Email address and telephone number.
- Any doing-business-as names.
- Brand names sold from the facility.
- Product categories manufactured or processed at the facility.
- Responsible Person information for each product category.
- FEI number, if already assigned.
- U.S. Agent contact information for foreign facilities.
- Submission type: initial, amended, biennial renewal, or abbreviated renewal.
FDA guidance also describes optional information, such as parent company name, facility DUNS number, and additional contacts. Keep optional items separate from required items so the filing team does not confuse commercial onboarding with FDA registration.
For Product Listing
For product listing, prepare:
- Product name as it appears on the label.
- Responsible Person name and contact number.
- Applicable cosmetic product category.
- Facility registration number for each manufacturing or processing facility.
- Ingredient list, including fragrances, flavors, and colors.
- Existing product listing number, if any.
- Submission type: initial, annual update, or abbreviated renewal.
- Label image, if available.
- Product webpage link, if available.
- Whether the product is professional-use only.
The product listing package should be built from final label and formulation information. Draft labels and incomplete ingredient lists create avoidable errors.
INCI Ingredient Names
INCI means International Nomenclature Cosmetic Ingredient. It is a standard naming system used for cosmetic ingredients. A simple example is “Aqua” instead of “Water.” Another is “Butyrospermum Parkii Butter” instead of only “Shea Butter.” For MoCRA registration and product listing, the ingredient list should be clean, consistent, and aligned with the product label. If your product uses fragrance, color additives, botanical extracts, or multiple variants, review the ingredient statement before submission.
Responsible Person Designation
Responsible Person does not mean U.S. Agent. The Responsible Person is the manufacturer, packer, or distributor whose name appears on the product label. The U.S. Agent is the U.S.-based contact for a foreign facility’s registration. These roles have different responsibilities. If your brand is outside the United States and your name appears on the product label, you may be the Responsible Person. Your foreign manufacturing facility may still need a U.S. Agent for facility registration. Do not merge those roles without reviewing the facts.
The U.S. Agent Requirement for Foreign Facilities
When a U.S. Agent Is Needed
A U.S. Agent is required for foreign facility registration under MoCRA. If your cosmetic manufacturing or processing facility is outside the United States and must register, the registration must include U.S. Agent contact information. This applies to many cosmetic companies in Europe, Latin America, Asia, the Middle East, and other regions that make products for the U.S. market.
What a U.S. Agent Does
A U.S. Agent acts as a U.S. contact for FDA communications related to the foreign facility. The U.S. Agent should have a U.S. physical presence. FDA guidance says the U.S. Agent should not be a mailbox, answering machine, or service where an individual acting as the foreign facility’s agent is not physically present. Typical U.S. Agent support may include:
- Receiving FDA communications for the foreign facility.
- Helping coordinate responses to FDA contact.
- Supporting communication during registration questions.
- Assisting FDA in communications with the foreign establishment.
- Assisting FDA in scheduling inspections of the foreign establishment.
- Receiving information or documents from FDA when FDA is unable to contact the foreign establishment directly or quickly.
What a U.S. Agent Does not Do
A U.S. Agent is not automatically the Responsible Person. A U.S. Agent also does not become the manufacturer, brand owner, safety guarantor, or product liability party simply because the agent is listed for facility registration. This distinction matters. The Responsible Person has product listing and other MoCRA-related accountability tied to the label role. The U.S. Agent is a separate facility registration contact for foreign facilities.
How to Designate a U.S. Agent
The U.S. Agent is identified in the facility registration submission. The information should match the agent’s actual business details and contact information. Inline CTA: Our Support Plans include U.S. Agent service for foreign cosmetic facilities. Start here: /services/.
For the full decision tree on whether your foreign facility needs a U.S. Agent, see our Do You Need a U.S. Agent? guide.
Step-by-Step: How to Register
MoCRA registration is not difficult when the information is organized. It becomes difficult when the facility, product, label, Responsible Person, and U.S. Agent data do not match.
Pre-registration Checklist
Before starting the submission, prepare these five items:
- Facility profile. Confirm the legal name, physical address, owner or operator, contact information, and activities.
- FEI number. Check whether the facility already has an FEI. If not, request one before facility registration.
- Product list. Identify every cosmetic product or product family marketed in the United States.
- Ingredient and label files. Prepare INCI ingredient lists and label images.
- Role map. Confirm the Responsible Person, U.S. Agent, manufacturer, contract manufacturer, importer, and brand owner.
FDA guidance states that FEI requests associated with cosmetic product facility registration are typically processed in 7–10 business days.
FDA Submission Portal
FDA developed Cosmetics Direct as an electronic submission portal for cosmetic product facility registration and product listing. FDA describes Cosmetics Direct as a Structured Product Labeling, or SPL, authoring tool that helps users enter data, validate it, create and save the SPL submission, and submit it to FDA for internal processing. FDA also allows other submission methods, including Electronic Submissions Gateway NextGen and paper forms. FDA strongly encourages electronic submissions to improve efficiency and timeliness.
The 6-step Submission Flow
A practical MoCRA registration flow looks like this: Step 1: Account setup. Create or access the required FDA account and confirm that the submitter can manage Cosmetics Direct submissions. Step 2: Facility profile. Enter the facility details, owner or operator information, physical address, contact data, FEI, brand names, product categories, and Responsible Person information. Step 3: U.S. Agent designation. For foreign facilities, add the U.S. Agent contact. Confirm that the agent information is accurate and active. Step 4: Product listing setup. Create product listings for marketed cosmetic products. Add product names, categories, Responsible Person details, ingredient lists, and facility registration numbers. Step 5: Review and validation. Check spelling, addresses, product categories, ingredient names, label consistency, and Responsible Person details. Small errors can create large delays later. Step 6: Submit and save records. Submit the registration or listing and save the confirmation, FEI, product listing numbers, and internal compliance file.
What Happens After Submission
After submission, FDA processes the information internally. For many companies, the key outputs are:
- FEI number or confirmed FEI use.
- Facility registration record.
- Product listing numbers.
- Submission confirmations or records.
- Renewal and update responsibilities.
Remember: FDA does not issue a MoCRA certificate. The practical proof is the facility registration and product listing record, not a decorative certificate.
Timeline: How Long Does Registration Take?
Same-day Submission Scenario
If your documents are ready, the active work can be fast. A prepared facility profile and clean product listing package may take one to two hours of active work per simple company setup. This assumes:
- FEI is already available.
- Facility details are complete.
- Labels are final.
- Ingredient lists are clean.
- Product categories are clear.
- U.S. Agent information is ready.
FDA Processing and Acknowledgment
Timeline depends on the submission method, the completeness of the file, and whether an FEI request is needed. FDA guidance states that FEI requests for cosmetic product facility registration are typically processed in 7–10 business days. For service planning, many companies should allow about 10–15 business days for internal review, submission handling, and confirmation steps. This is a planning estimate, not an FDA guarantee.
Real-world End-to-end Timeline
A realistic end-to-end timeline is often two to three weeks when the company starts with incomplete information. That timeline may include:
- Collecting facility information.
- Checking or requesting FEI.
- Reviewing labels.
- Cleaning ingredient lists.
- Confirming the Responsible Person.
- Confirming U.S. Agent information.
- Preparing and submitting listings.
What Causes Delays
Common delay causes include:
- Missing FEI.
- Facility address mismatch.
- Incomplete labels.
- Ingredient lists that do not match labels.
- Non-INCI ingredient names.
- Confusion between brand owner and Responsible Person.
- Missing U.S. Agent for a foreign facility.
- Too many product variants without a listing plan.
- Unclear contract manufacturer relationships.
The fastest MoCRA registration is not the one rushed into the portal. It is the one prepared correctly before submission.
Renewal Cycles — Biennial vs. Annual
Facility Registration: Biennial
Facility registration must be renewed every two years. FDA’s Feb. 11, 2026 Cosmetics Constituent Update states that every person required to register a cosmetic product facility must renew that registration biennially, or every two years, as required under Section 607(a)(2) of the FD&C Act. FDA also explains that renewal dates are based on the initial registration date; for example, if FDA received the initial registration on Feb. 20, 2024, the renewal date would be by Feb. 20, 2026. Source: https://www.fda.gov/cosmetics/cosmetics-news-events/fda-updates-web-portal-and-informational-materials-help-cosmetic-facilities-prepare-biennial
⚠️ Note: Renewals are biennial — never call them annual. Also, do not rely on a fixed calendar window. Check the renewal date shown in Cosmetics Direct or in the facility’s registration records.
Product Listing: Annual Updates
Product listings work on a different cycle. FDA states that a Responsible Person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually. Product listing records should also be reviewed when product data changes. Examples include reformulation, new ingredient information, a label change that affects listing data, a discontinued product, or a new facility tied to the product.
The Calendar Trap
The calendar trap is simple: facility registration and product listing are not the same filing and do not follow the same update logic. A company may renew facility registration every two years but still need product listing updates every year. A brand may also need to update product listing information when product data changes. For international brands with many SKUs, this is where compliance tracking becomes important. A spreadsheet is better than memory. A CRM task or renewal reminder is better than a spreadsheet.
What Triggers a Mid-cycle Review
A mid-cycle review may be needed when key information changes. Examples include:
- Facility address changes.
- Facility contact changes.
- U.S. Agent changes.
- Responsible Person information changes.
- Product discontinuation.
- Product reformulation.
- Label changes that affect listing information.
- New product categories.
- New manufacturing or processing facilities.
Do not wait until renewal if required information has changed.
Costs Explained
FDA Filing Cost
As of this update, MoCRA facility registration and product listing do not require an FDA filing fee. Our pricing is for consulting, preparation, filing support, U.S. Agent service when applicable, tracking, and support. This distinction matters. A private service fee is not an FDA fee. A support plan is not an FDA certificate. A submission record is not FDA approval.
⚠️ Note: We never charge an “FDA fee” line item for MoCRA registration. We also never present a decorative “MoCRA certificate” as an FDA-issued document.
Consulting and Service Fees
Service fees usually cover the work that prevents avoidable mistakes:
- Reviewing whether the facility appears required to register.
- Checking FEI status.
- Preparing facility information.
- Reviewing product categories.
- Organizing product listings.
- Checking ingredient and label consistency.
- Coordinating U.S. Agent designation.
- Tracking renewal and annual update deadlines.
- Responding to client questions after submission.
U.S. Agent Fees for Foreign Facilities
Foreign facilities need a U.S. Agent for registration purposes. That service may be billed as part of a MoCRA registration package or as a separate support service. A low-cost U.S. Agent service that does not monitor communications, update records, or coordinate responses may create risk. The agent should be reachable and physically present in the United States.
The DUNS Question
DUNS is often requested by commercial partners, but it is not the same as FEI. For MoCRA registration, do not spend time solving a DUNS issue if the actual submission needs FEI. A retailer may ask for DUNS. A freight forwarder may ask for DUNS. A marketplace may ask for DUNS. FDA facility registration uses FEI.
Our Pricing
Our MoCRA Registration Support Plans are:
- $595 — 1-Year Support Plan
- $995 — 2-Year Support Plan, best value
Both plans are designed for cosmetic brands and facilities that want filing support, U.S. Agent support when applicable, and practical guidance after submission. Start your support plan here: /services/.
6 Common Mistakes Brands Make
Confusing DUNS with FEI
This is the No. 1 confusion. DUNS is a Dun & Bradstreet commercial identifier. FEI is the FDA Establishment Identifier used for facility registration. FDA guidance defines both separately and states that FDA intends to use FEI as the cosmetic product facility’s registration number. Fix: Check FEI first. Handle DUNS only if a retailer, importer, or commercial partner asks for it.
Missing the Biennial Renewal
Facility registration is not a one-time task. It must be renewed every two years. FDA’s Feb. 11, 2026 update says renewal is based on the initial registration date, and Section 607(a)(2) of the FD&C Act is the statutory basis for biennial renewal. Fix: Save the renewal date in your compliance calendar, CRM, and email reminders.
Listing Only “primary” Products
Some brands list the hero product and forget variants, sizes, shades, fragrances, or related SKUs. FDA guidance allows one listing to include multiple products with identical formulations or formulations that differ only by colors, fragrances, flavors, or quantity of contents. But you still need a clear product listing strategy. Fix: Build a product matrix before submission.
Naming the Wrong Responsible Person
The Responsible Person is tied to the name on the label. It is not always the contract manufacturer. It is not automatically the importer. It is not automatically the U.S. Agent. Fix: Review the label before assigning the role.
Assuming MoCRA Equals an FDA Certificate
FDA does not issue MoCRA certificates. Anyone selling an “FDA MoCRA certificate” as if it were issued by FDA is misrepresenting the process. FDA states that facility registration and product listing are not an approval program or promotional tool, and that FDA does not issue certificates for them. Fix: Use real submission records, FEI information, and product listing records as compliance evidence.
Skipping U.S. Agent for Foreign Facilities
A foreign facility that must register needs U.S. Agent information. FDA guidance says foreign facility registration includes the U.S. Agent contact, and that the U.S. Agent must be physically present in the United States. Fix: Designate a real U.S. Agent before submission, not after a portal error or retailer request.
What Happens if You Don’t Register?
Import Detention or Commercial Delays
If your cosmetic products enter the U.S. market without required compliance steps, importers, brokers, platforms, or retailers may delay the shipment or ask for documentation. MoCRA registration is not the only import requirement, but it has become part of the compliance conversation for cosmetic products sold in the United States.
FDA Warning Letters and Public Risk
FDA warning letters are public records. Even when a company later corrects an issue, the public record can create reputational risk with retailers, distributors, investors, and customers.
Recalls and Suspension Risk
MoCRA gives FDA expanded authority in certain safety situations, including mandatory recall authority and facility registration suspension authority. FDA states that if a facility registration is suspended, it is a prohibited act to distribute or sell cosmetic products from that facility in the United States.
Retailer and Marketplace Requirements
Retailers and marketplaces may ask for proof that your company understands MoCRA registration. They may request FEI, product listing support, label records, U.S. Agent details, or Responsible Person information. Compliance is the cheapest line on your P&L. Non-compliance can become the most expensive lesson.
Frequently Asked Questions
What Is MoCRA and Why Do I Need to Comply?
MoCRA is the U.S. law that created new FDA requirements for many cosmetic companies, including facility registration and product listing. You may need to comply if your company manufactures, processes, distributes, or sells cosmetic products in the United States and your role falls within MoCRA’s registration or listing requirements. MoCRA registration helps FDA identify cosmetic facilities and marketed products, but it is not product approval. Next step: Review your facility and product roles, then start at /services/.
What’s the Difference Between FEI and DUNS?
FEI is the FDA Establishment Identifier. It is the FDA identifier used as the cosmetic product facility registration number. DUNS is a commercial identifier from Dun & Bradstreet. It may be useful for business, logistics, or retailer onboarding, but it is not the same as FEI. For MoCRA registration, confirm FEI first. Next step: If your facility does not have an FEI, request it before facility registration.
Do I Need a U.S. Agent if I’m Outside the U.S.?
If your foreign facility must register under MoCRA, yes, the facility registration must include U.S. Agent contact information. The U.S. Agent must reside in the United States or maintain a U.S. place of business and be physically present in the U.S. The U.S. Agent is not the same as the Responsible Person. Next step: Our MoCRA support plans include U.S. Agent service for foreign facilities: /services/.
How Often Must I Renew?
Facility registration must be renewed every two years. FDA’s Feb. 11, 2026 update says renewal is based on the facility’s initial registration date, and Section 607(a)(2) of the FD&C Act is the statutory basis for biennial renewal. Product listings require annual updates. This is a separate cycle. Do not call facility renewal annual, and do not treat product listing updates as biennial. Next step: Create two reminders: one for facility renewal and one for product listing updates.
Will FDA Issue Me a Certificate?
No. FDA does not issue MoCRA certificates. FDA states that cosmetic product facility registration and product listing are not an approval program or promotional tool, and that FDA does not issue certificates for them. Next step: Keep submission records, FEI information, and product listing records. Do not rely on a decorative certificate.
How Long Does the Registration Process Take?
If your documents are ready, active preparation and submission may be completed quickly. If you need FEI, label review, ingredient cleanup, or U.S. Agent setup, plan more time. FDA guidance states that FEI requests associated with cosmetic facility registration are typically processed in 7–10 business days. A practical end-to-end timeline is often two to three weeks when documents are incomplete. Next step: Prepare the checklist before opening the submission.
What Documents and Information Do I Need?
You need facility information, FEI, owner or operator details, contact information, product categories, brand names, Responsible Person details, U.S. Agent details for foreign facilities, product names, categories, ingredient lists, and label files. The exact information depends on whether you are filing facility registration, product listing, or both. Next step: Send your facility and product list through /contact/ or ask a question first on WhatsApp.
Your Next Step
MoCRA registration is not only a form. It is a compliance system for your cosmetic facility, products, labels, roles, and renewal calendar. Here is the short recap:
- Two filings: facility registration for the “where” and product listing for the “what.”
- Two cycles: facility renewal every two years and product listing updates annually.
- One key foreign-facility requirement: a real U.S. Agent for facilities outside the United States.
Get MoCRA Registration support:
- $595 — 1-Year Support Plan
- $995 — 2-Year Support Plan, best value
Primary CTA: Start your registration here: /services/. Have a question first? Message us on WhatsApp: wa.me/13056109953 or use /contact/. Reviewed by REGISTRO-FDA.US Compliance Team. Author: Gustavo Zapata, Co-founder REGISTRO-FDA.US — /author/gustavozapata/ Last updated: May 27, 2026. Disclaimer: This article is educational information only and is not legal advice. REGISTRO-FDA.US is a private consulting company and is not affiliated with FDA.
