MoCRA establishes registration and listing requirements for manufacturing facilities and cosmetic products.
Facility registration and product listing can be submitted to the FDA via paper forms. Nevertheless, the FDA encourages electronic submission to streamline the process. To this end, the FDA launched Cosmetics Direct, an electronic portal for MoCRA registrations. Considering that the portal was launched only in December 2023, the FDA announced that they will not enforce registration requirements before 1 July 2024. This date is six months after the statutory deadline of 29 December 2023 to allow the industry enough time to comply.
Cosmetics Direct is one of the two modules of FDA Direct. The second module is CDER Direct for drug registrations, such as drug establishment registration and listing. Users can create an account for only one module or a combined account that grants access to both, depending on their needs.
As an alternative to Cosmetics Direct, companies can use SPL-formatted submissions through the FDA Electronic Submissions Gateway (ESG), or any SPL authoring software.
Types of registrations
Regarding cosmetic facilities, the following types of registrations can be performed within Cosmetics Direct:
- Initial
- Amendment – To be completed within 60 days of any changes in the information of the registration
- Biennial registration renewal – MoCRA imposes to renew the facility registration every two years
- Abbreviated registration renewal – In case at the time of renewal, there have been no changes to the previous version
- Cancellation
For product listing, the portal includes the following types of registration:
- Initial
- Update – The product listing must be renewed annually, and the user should indicate whether there have been any changes to the product or if it has been discontinued
- Abbreviated renewal – In case at the time of renewal, there have been no changes to the previous version
When the user completes the registration, the system validates it and scans for certain errors. Afterwards, the registration can be submitted to the FDA which will accept or reject it. If case the submission fails, the system will highlight which requirements are not met.
FEI numbers
For cosmetic facilities, it is important to highlight that obtaining an FDA Establishment Identifier (FEI) is an essential preliminary step to the facility registration. If a facility does not have an FEI, it can request it from the FDA providing the details of the company and its activities. The public can check the FEI of a company in the FEI Search Portal. Having a FEI number is not equivalent to being registered as a facility, which is an additional step as explained above.
Do you need help to comply with MoCRA? Obelis, with 35 years of international regulatory experience, is the ideal partner to support you in the compliance journey. Contact us today to discover our US services dedicated to manufacturers, brand owners, and producers of cosmetic products.
Francesca Santacatterina
Regulatory Intelligence and Innovation Department
20.03.2024
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