On December 18, 2023, the U.S. Food and Drug Administration (FDA) officially announced the launch of the Cosmetic Direct electronic submission portal for cosmetic facility registration and product listing,1 accompanied by the release of a comprehensive User’s Guide.2
Chemlinked will continue to provide updates on any pertinent information related to the portal for registration and listing submissions. For further insights into MoCRA, please explore ChemLinked's new Featured page: Navigating US Cosmetic Regulations: MoCRA and Beyond.
News Released on December 16:
On December 16, 2023, the U.S. Food and Drug Administration (FDA) unveiled the public beta version of Cosmetic Direct, the new electronic submission portal designed for cosmetic facility registration and product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) framework. This version marks the final test before the official launch.
Introduction to the Public Beta Portal
Formerly recognized as FDA Direct for drug registration, this web-based and free structured product labeling (SPL) authoring portal has undergone an update and is now referred to as "FDA Direc, CDER Direct & Cosmetics Direct." It offers the creation of three account types: drug account (CDER Direct), cosmetics account (Cosmetics Direct), and a combined account (CDER Direct and Cosmetics Direct). Importantly, the application for a cosmetics account eliminates the need for DUNS number.
On the Home Page, companies can find two registration selections: Registration of Cometic Product Facility and Cosmetic Product Listing. The necessary information for facility registration includes details about the facility, FDA Establishment Identifier (FEI) number, product category, responsible person’s information, and more.
For product listing, mandatory details involve responsible person’s information, product information, FEI number, and so on.
Instructions for Electronic Submissions
In accordance with the MoCRA legislation enacted on December 29, 2022, production facilities and responsible persons are obligated to register their facilities and list their products within the specified timeframe. The FDA, on September 18, 2023, released the draft guidance on the electronic submission portal for cosmetics, providing comprehensive operational instructions. This draft serves as a valuable reference for navigating the current electronic submission portal.
While the FDA encourages electronic submissions and emphasizes the advantages of efficiency and timely data management, stakeholders can still opt for traditional paper submission by using FDA Forms 5066 and 5067, which are currently under development. By comparing the required information in the public beta version and the draft Forms 5066 and 5067, the system's requirements align closely with those of the paper forms.
It is noteworthy that although the statutory deadline for facility registration and product listing remains December 29, 2023, the FDA has postponed enforcement until July 1, 2024, extending the compliance window by six months. In light of this, ChemLinked advises enterprises to proactively prepare the necessary information and documentation per MoCRA and relevant FDA guidelines during this period. This preparation ensures a smooth compliance process. Additionally, close attention should be paid to the official launch of the Cosmetic Direct portal.
For additional insights, please refer to ChemLinked's New Feature on this topic.