MoCRA updates: US FDA unveils the draft guidance for cosmetic facility registration and product listing

MoCRA updates: US FDA unveils the draft guidance for cosmetic facility registration and product listing

On August 7, 2023, the U.S. Food and Drug Administration released a draft guidance on cosmetic facility registration and product listing (draft guidance), which explained in detail the two mandatory obligations for enterprises from the Modernization of Cosmetics Regulation Act of 2022 (MoCRA): facility registration and product listing. The consultation period for this draft will run until September 7, 2023.

Facility registration: All entities engaged in the manufacture or processing of cosmetic products for the U.S. market—regardless of their geographical location—must register their facilities with the FDA. Facilities in operation when MOCRA was enacted must complete registration with the FDA by December 29, 2023. New facilities must be registered within 60 days after they begin manufacturing or processing cosmetics, or within 60 days after December 29, 2023, whichever is later. 

 Product listing: Responsible person for cosmetics intended for sale in the U.S., namely, manufacturer, packer and distributor of a cosmetic product whose name appears on the label, must list each marketed cosmetic product, including product ingredients, with the FDA. Existing cosmetic products, which were already on the market prior to the enactment of MoCRA, must be listed with the FDA no later than December 29, 2023. For new products introduced to the market after MoCRA’s enactment, the listing with the FDA should be done within 120 days from the date of their initial marketing.

Key Updates

This draft guidance refines the statutory requirement for cosmetic facility registration and product listing. It clarifies the definitions of key terms such as “contract manufacturer”, “responsible person”, “facility”, “DUNS number”, etc., and offers comprehensive guidance on the entities responsible for submitting applications for registration and listing, the necessary dossiers, submission methods, submission deadlines, and exemptions from registration and listing requirements, etc.

For a comprehensive understanding of the procedures for facility registration and product listing, please refer to the following two articles:

Moreover, the draft guidance introduces additional details, including the rollout schedule for a new electronic portal for enterprises to submit registration and listing, as well as the adoption of the FDA Establishment Identifier (FEI) as the facility registration number.

  • New Electronic Submission Portal

FDA has announced its plan to launch a new electronic submission portal in October 2023. This portal will serve as the designated platform for submitting facility registration and product listing information. Businesses are strongly encouraged to utilize electronic submissions as it enhances the efficiency and timeliness of data submission. As an alternative, the paper form is also being developed.

In line with this, the FDA is inviting industry players to partake in user acceptance testing pilot program to evaluate the future new electronic submission portal. This initiative, accepting up to nine participants, aims to gather valuable feedback from them for portal improvement. Interested stakeholders can apply electronically via

  • Adoption of FDA Establishment Identifier (FEI)

FDA will employ the FDA Establishment Identifier (FEI) as the required facility registration number. Prior to initiating the facility registration process, facility owners or operators are required to obtain an FEI number.

Notably, responsible persons are obligated to obtain relevant FEI numbers for each manufacturing or processing facility associated with their cosmetic products, as the facility registration number is a prerequisite for product listing submission. Small businesses exempt from registration can utilize their facility name/address in lieu of the facility registration number for product listing.

ChemLinked Suggestions

Considering the imminent launch of the new submission portal in October 2023, it’s urgent to act. To ensure a seamless transition into the new regulatory landscape, ChemLinked recommends stakeholders take the following proactive measures:

  • Organize and sort out existing cosmetic products. This should encompass comprehensive details such as product names, labels, and ingredient information. This groundwork will significantly accelerate the registration process once the submission system is accessible.
  • Initiate FEI Number Application: For enterprises yet to acquire an FEI Number, it’s recommended to initiate the application promptly. This critical step is essential for a smooth engagement with the impending product listing submission.

Further Reading

ChemLinked Cosmetic Portal ( is a media platform operated by REACH24H Consulting Group. Our focus is on providing comprehensive one-stop-market access information services and solutions to members of the cosmetics industry, including domestic and foreign manufacturers, trade logistics, raw material companies, as well as government departments, industry associations, and research institutions.

We offer a wide range of global cosmetic market entry services, including Global News Alerts, Cosmetics Product Registration and Notification, New Cosmetic Ingredient (NCI) Registration/Notification, Regulatory Consultation, Customized Training, Market Research, and Branding Strategy. Please contact us to discuss how we can help you by


Winnie Xu

ChemLinked Regulatory Analyst, REACH24H Consulting Group

Winnie Xu is an experienced cosmetic regulatory analyst in the ChemLinked team tasked with tracking, analyzing and interpreting the latest regulatory and market changes in China, Japan, and the rest of the Asia Pacific area. She has published a number of news and articles on cosmetic regulatory compliance and involved in various industry conferences.

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