Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Cosmetics News & Events

Cosmetics News & Events

                        Meetings, Conferences & Workshops on Cosmetics Home
          Cosmetics
          Cosmetics News & Events
          FDA Announces Launch of Cosmetics Direct for Electronic Registration and Listing of Cosmetic Product Facilities and ProductsCosmetics News & Events FDA Announces Launch of Cosmetics Direct for Electronic Registration and Listing of Cosmetic Product Facilities and Products
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintCosmetics Constituent Update

December 18, 2023

Today the U.S. Food and Drug Administration (FDA) announced the launch of its Cosmetics Direct electronic submission portal for registration and listing of cosmetic product facilities and products, mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

The Cosmetics Direct portal, now available for industry, is dedicated exclusively to cosmetic product facility registration and cosmetic product listing electronic submissions to FDA. Cosmetics Direct is accessed at https://direct.fda.gov/.

Cosmetics Direct is an FDA Structured Product Labeling (SPL) authoring tool, for cosmetic product facility registration and cosmetic product listing, with user-friendly data entry forms that creates, validates, saves, submits, processes, and automatically transmits the SPL submission to FDA for internal processing without having to use the Electronic Submissions Gateway (ESG).

FDA is also accepting cosmetic product facility registration and cosmetic product listing submissions via SPL-formatted submissions through the ESG. In addition, FDA is also developing SPL-X forms that is anticipated to be available soon.

FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency.

FDA is also developing paper forms for cosmetic product registration and cosmetic product listing as an alternative submission tool that are anticipated to be available soon.

**Delayed Enforcement**

On November 8, 2023, FDA issued guidance on its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under MoCRA for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information.

FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.

In addition, FDA does not intend to enforce the registration requirement for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022, or the listing requirement for cosmetic products first marketed after December 29, 2022, until July 1, 2024.

Related Resources

Cosmetics Direct

	For assistance with validation errors in Cosmetics Direct, contact cosmeticsdirect@fda.hhs.gov
		For general questions regarding cosmetic product facility registration and cosmetic product listing, contact eRLC@fda.hhs.gov
	Electronic Submissions Gateway  
	For technical assistance, contact ESGHelpDesk@fda.hhs.gov
	Structured Product Labeling (SPL) Resources
	Structured Product Labeling (SPL) Implementation Guide with Validation Procedures
	Registration & Listing of Cosmetic Product Facilities and ProductsFor More Information

Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing
	Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products

                                                                                  Content current as of:
      12/18/2023
              
              
Regulated Product(s)
		 CosmeticsCosmetics News & Events

          
                        Meetings, Conferences & Workshops on Cosmetics
 SUBSCRIBE
                      Get regular FDA email updates delivered on this topic to your inbox.
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop