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Registration & Listing of Cosmetic Product Facilities and Products

What’s New?

February 11, 2026

Today, the U.S. Food and Drug Administration announced updates to its Cosmetics Direct electronic submission portal, its user guide, and other materials, to assist in the biennial registration of cosmetic product facilities as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Cosmetics Direct now displays two new fields, REGISTRATION STATUS and RENEWAL DATE, in the latest version of the cosmetic product facility registration homepage.

Every person who is required to register a facility must renew such registration biennially (i.e., every two years) (section 607(a)(2) of the FD&C Act). For each registered facility, the facility contact, the FDA Direct account contact (Cosmetics Direct or Combined CDER Direct and Cosmetics Direct), U.S. agent, additional contact and paper submitter (as applicable) will receive automated email reminders before the facility registration renewal date. 

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law will help ensure the safety of cosmetic products many consumers use daily.

MoCRA provided new authorities to FDA including:

 

Manufacturers and processors must register their facilities with FDA and renew their registration every two years. FDA has the authority to suspend a facility’s registration if the agency determines that a cosmetic product manufactured or processed by the registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans, and the agency has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility. If a facility’s registration is suspended, it is a prohibited act to distribute or sell (or otherwise introduce or deliver for introduction into interstate commerce) in the United States cosmetic products from the facility.

Renewal of Registration 

Every person who is required to register a facility must renew such registration biennially (i.e., every two years) (section 607(a)(2) of the FD&C Act). FDA is providing for an abbreviated renewal of registrations when there have not been any updates to the registration since the most recent facility registration submission, as required under section 607(a)(5) of the FD&C Act. 

A cosmetic product facility needs to renew its registration every two years from the date of initial registration.

  • Renewal dates are based on the initial registration date. For example, if FDA received your initial registration on February 20, 2024, then your renewal date would be by February 20, 2026. 
  • Renewals can be submitted earlier than two years. For example, if you would like to renew your cosmetic facility registration along with your CDER annual establishment registration renewal that is due earlier.

Facilities can renew their cosmetic product facility registration in Cosmetics Direct by selecting the latest version of the Structured Product Labeling (SPL) and using one of the following two renewal submission options:

  • COSMETIC PRODUCT FACILITY REGISTRATION - BIENNIAL RENEWAL (for facility registration renewals with changes)
  • COSMETIC PRODUCT FACILITY REGISTRATION - ABBREVIATED RENEWAL (for facility registration renewals without changes)

For instructions on how to renew your cosmetic product facility registration, see:

Facilities can also renew their cosmetic product facility registration using paper forms (see Paper Submissions below). FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency.

 

A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually. 

Responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

 

MoCRA exempts certain small businesses from facility registration and product listing requirements.

However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:

  • Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.
  • Products that are injected.
  • Products that are intended for internal use.
  • Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use. 

Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.

 

Important Notes

Cosmetic product facility registration and product listing is neither a cosmetic approval program nor a promotional tool. FDA does not issue “certificates” for cosmetic product facility registrations or product listings.

 

 

Registration and Listing Reports

The summary table below provides the number of the unique, active cosmetic product facilities registered and unique, active cosmetic products listed under MoCRA.

MoCRA 
Registration of Cosmetic Product
Facilities and Cosmetic Product Listings
(Since December 18, 2023)

Number of unique, active facility registrations1,2,3

14,299

Number of unique, active product listings1,2,4

992,907

1Data Sources = Cosmetics Direct, Electronic Submission Gateway (ESG), Structured Product Labeling (SPL) authoring software, and paper submissions
2Data as of January 6, 2026    
3Unique, active facility registrations = the number of active cosmetic product facilities registered
4Unique, active product listings = the number of active cosmetic products listed   Additional information about the number of unique, active cosmetic product facilities that have registered with FDA under MoCRA can be downloaded here.

Additional information about the number of unique, active cosmetic product facilities that have registered with FDA under MoCRA can be downloaded here.

 

 

For Industry

Decision Tool

FDA has developed a tool to help you decide if you are required to register a cosmetic product facility. To use the tool, visit Decision Tool and answer a series of questions.

Submissions

Below are options for registration and listing submissions:

Electronic Submissions 

Cosmetics Direct

Cosmetics Direct is an FDA provided Structured Product Labeling (SPL) authoring tool, for cosmetic product facility registration and cosmetic product listing, that contains user friendly data entry forms, performs initial validations, creates and saves the SPL submission, and submits the SPL to FDA for internal processing without having to use the Electronic Submissions Gateway Next Generation (ESG NextGen). 

SPL, an established document sanctioned by health level seven (HL7) for the exchange of product and facility-related information, serves as a foundational reference for regulatory guidance documents and product labeling content exchange. It enforces control over crucial product information, resulting in a standard for product labeling. The FDA has adopted SPL to enhance patient/customer safety and product usability within its consumer base. In 2005, the FDA mandated the use of XML compliant with the SPL standard for electronic submissions. This standard defines the content and structure of product labeling required for submission to the FDA. Consistent structure and standard terminology are employed to enhance the accuracy and reliability of product information. For additional information, see the Structured Product Labeling (SPL) Implementation Guide with Validation Procedures. 

Electronic Submissions Gateway Next Generation (ESG NextGen)

As an alternative, cosmetic product facility registrations and cosmetic product listing may be submitted online through FDA’s Electronic Submissions Gateway Next Generation (ESG NextGen), or any Structured Product Labeling (SPL) authoring software including SPL Xforms. The FDA ESG NextGen system requires users to apply for a free account before submitting data, a process which can take one to three weeks. FDA therefore urges registrants to apply for ESG NextGen accounts well in advance of the statutory deadline for data submission. Technical assistance is available for users by contacting the ESG NextGen at ESGNGSupport@fda.hhs.gov.

SPL Xforms

Xforms is one option of creating an SPL file with cosmetic product facility registration and cosmetic product listing information.

Paper Submissions 

FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency. Paper forms are available below:

Voluntary Registration

FDA welcomes voluntary registration and listing submissions for those cosmetic product facilities and products that are not required to register, i.e., if entities exempt from MoCRA registration and listing provisions want to make a submission then they can make it voluntarily. If you voluntarily register or list, information for all fields designated as mandatory will need to be filled due to technical limitations of the system.

Guidance 

Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products 
(December 2024)
FDA guidance on cosmetic product facility registrations and product listings, as mandated by the MoCRA.

FEI Search Portal 

FEI Search Portal for Required Facility Registration Number
FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number. To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration. To determine if an entity already has an FEI number, please refer to the FEI Search Portal. If your firm does not have an FEI number assigned by FDA, see How can I request an FEI? at FEI Search Portal. 

 

Announcements

 



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