On November 8, 2023, the FDA officially announced that they will not enforce MoCRA requirements on facility registration and product listing until July 1, 2024, to give the industry more time to comply. This date is six months after the statutory deadline of December 29, 2023, which cannot be changed as it is established within the law. However, the FDA confirmed that the electronic submission portal (Cosmetics Direct) will be ready in early December 2023, and they advise companies to meet the original deadline if they can do so.
Cosmetics Direct is not available yet: the FDA is developing it and will conduct a pilot program in the next weeks to ensure that companies that want to submit their registrations by December 29, 2023, can do it. In the communication, the FDA also clarified that submissions can be done through any Structured Product Labeling (SPL) authoring software, such as the FDA’s Electronic Submissions Gateway (ESG) and Xforms. Furthermore, the FDA strongly encourages electronic submissions over paper ones, even though they informed the industry they are working on two paper forms, Forms 5066 for facility registration and 5067 for product listing.
What now?
Companies should use the additional time to comply with MoCRA requirements.
Now, as a beauty brand selling cosmetics in the United States, you should take the following actions already:
- Verify your suppliers are aware of MoCRA and are taking the necessary steps to comply;
- Obtain the FDA Establishment Identifier (FEI) from your facilities — This number will be essential for you to list your products;
- Make sure non-US facilities have appointed a US Agent;
- Gather the other information required for facility registration and product listing;
- Ensure you comply with other MoCRA requirements.
It is also important to highlight that other MoCRA requirements will start applying on December 29, 2023, and there will be no postponed enforcement. By end of 2023, cosmetic brands selling in the United States will have to:
- Have a system in place for recording and evaluating adverse events and reporting serious adverse events;
- Hold a safety substantiation dossier for each cosmetic product, including all evidence that the cosmetic is safe for use.
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.
Don’t let regulatory changes hold your business back. Contact us today to learn how we can help you stay ahead of the game.
Francesca Santacatterina
Publications Department
09.11.2023
Reference:
- FDA. (2023). Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing — Guidance for Industry. Retrieved on 09.11.2023