FDA Cosmetic Facility Registration Services
Which cosmetic facilities must register with the FDA?
Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), any company or individual that owns or operates a cosmetic manufacturing or processing facility must complete FDA facility registration when cosmetic products are manufactured or processed for distribution in the United States. This requirement applies to both U.S.-based and foreign facilities supplying the U.S. market.
Only one FDA facility registration is required per facility, even when multiple brands or responsible persons are supported at the same location. While the FDA does not charge a fee for facility registration, accuracy, completeness, and timely submission are essential to maintain compliance.
Are any cosmetic facilities exempt from FDA facility registration?
MoCRA provides limited exemptions from FDA cosmetic facility registration. Exemptions apply to:
- Small businesses that fall below specific sales thresholds and do not manufacture or process higher-risk cosmetic products, as defined in Section 612(b) of the Federal Food, Drug, and Cosmetic Act
- Facilities regulated under Chapter V of the FD&C Act
- Establishments that only perform labeling, relabeling, packaging, repackaging, holding, or distribution without manufacturing or processing
- Beauty salons, retail outlets, and service providers that do not manufacture products
Correctly identifying whether an exemption applies is particularly important for private-label brands, contract manufacturing arrangements, and international supply chains.
What information is required for FDA cosmetic facility registration?
The following information must be submitted as part of FDA facility registration:
- The name of the facility owner and/or operator
- The facility name, physical address, email address, and telephone number
- S. agent contact details for foreign facilities
- The facility registration number, if previously assigned
- All cosmetic brand names manufactured or processed at the facility
- The applicable cosmetic product categories and responsible persons
- The type of registration submission
Where applicable, the facility registration number should be obtained before beginning the submission.
Who can access the information submitted to the FDA?
The information regarding brand names under which cosmetic products are manufactured or processed at a facility is not disclosed publicly. All other information submitted as part of cosmetic facility registration may be available for public disclosure.
Where is FDA cosmetic facility registration submitted?
The FDA encourages electronic submission of cosmetic facility registration information through the Cosmetics Direct portal, made available by the FDA. As an alternative, cosmetic product facility registrations may also be submitted through the FDA’s Electronic Submissions Gateway (ESG) or compatible SPL authoring software.
Paper submissions are also available.
When must FDA cosmetic facility registration take place?
FDA facility registration includes the following submission types and timelines:
- Initial registration must be completed within 60 days of first manufacturing or processing a cosmetic product for distribution in the United States
- Amended registration must be submitted within 60 days of any changes to required registration information, including changes that result in cancellation
- Renewal of registration must be completed biennially
What is the FDA facility registration database?
The FDA facility registration database contains registration information for cosmetic manufacturing and processing facilities that have submitted their details under MoCRA. While brand names are not publicly disclosed, other facility registration details may be accessible.
This database is commonly used by brands, partners, and regulators to verify registration status and support compliance and due diligence activities.
What will Taobé do to support FDA cosmetic facility registration?
Taobe supports cosmetic brands throughout the FDA facility registration process, including:
- Assessing whether a facility is required to register under MoCRA
- Confirming whether any exemptions apply
- Preparing and reviewing facility registration data
- Supporting submission through the Cosmetics Direct portal or other FDA-approved systems
- Managing amendments, renewals, and ongoing registration maintenance
FDA Cosmetic Facility Registration FAQs
What is FDA cosmetic facility registration?
FDA cosmetic facility registration is a MoCRA requirement for facilities that manufacture or process cosmetics for U.S. distribution.
Who must register a cosmetic facility with the FDA?
Any domestic or foreign facility that manufactures or processes cosmetic products for distribution in the United States.
Is FDA cosmetic facility registration mandatory under MoCRA?
Yes. Facility registration is mandatory under the Modernization of Cosmetics Regulation Act of 2022.
Are foreign cosmetic manufacturers required to register with the FDA?
Yes. Foreign facilities must register and appoint a U.S. agent.
Are any cosmetic facilities exempt from FDA registration?
Yes. Some small businesses and non-manufacturing establishments may qualify for exemptions.
Is there a fee for FDA cosmetic facility registration?
No. The FDA does not charge a fee for cosmetic facility registration.
Where is FDA cosmetic facility registration submitted?
Registrations are submitted electronically through the FDA Cosmetics Direct Portal.
What is the FDA cosmetic facility registration database?
It is the FDA’s public database listing registered cosmetic manufacturing and processing facilities.
How often must FDA facility registration be renewed?
Facility registration must be renewed every two years.
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Why employ Taobé for FDA cosmetic facility registration?
FDA facility registration is a regulatory requirement with public visibility and ongoing maintenance obligations. Employing Taobe helps cosmetic brands reduce the risk of errors, inconsistent submissions, or missed updates across facilities or markets.
Taobe supports both U.S. and international cosmetic brands and works closely with internal teams and manufacturing partners to manage FDA facility registration requirements under MoCRA.
Our Mocra Services
FDA cosmetic labeling requirements
Receive expert guidance to create cosmetic labels that are accurate, FDA-compliant, and meet both federal and state-specific regulations.
Cosmetic formula check
Ensure your cosmetic formulations comply with FDA and state laws through a detailed ingredient review and safety compliance evaluation.
Cosmetic product safety substantiation
Choose expert safety assessors to prepare and maintain your cosmetic product safety substantiation in compliance with MoCRA.
US FDA agent
Choose an experienced FDA agent to manage regulatory correspondence and support compliance for your cosmetics in the US.
US responsible person
Designate a trusted US Responsible Person to manage product safety, regulatory submissions, and ongoing FDA compliance.
Cosmetic product listing
Submit precise cosmetic product listings to meet FDA registration rules and simplify your access to the US market.
