On August 7, 2023, the US Food and Drug Administration (FDA) published the first draft Guidance on the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The draft Guidance provides the industry with instructions on the new MoCRA requirements for cosmetic product listing and facility registration.
MoCRA provides that by December 29, 2023, cosmetic products sold in the United States must be listed to the FDA. Additionally, facilities all over the world manufacturing or processing cosmetic products for distribution in the US must register with the FDA. Considering the deadline is approaching, everyone in the business is wondering how to prepare. In this regard, the draft Guidance confirms that the electronic submission portal for product listing and facility registration will be available as of October 2023. Submissions will be made using structured product labeling (SPL) format. Furthermore, there will also be an alternative paper form for submission, although electronic applications are encouraged.
Taking into account the huge number of products and facilities to register, we highly recommend you start collecting the submission information already to be ready once the portal is operational.
How can Obelis help you?
If you appoint Obelis as your US Agent or regulatory consultant, we will list your products and register your facilities. And we will do much more! Our team of regulatory professionals will support you to ensure your products meet MoCRA requirements and can be lawfully sold in the United States. We will make the compliance path as easy as possible.
Do you want more information on the FDA draft Guidance? Check our article on COSlaw for a summary of key points from the draft Guidance, or listen to our dedicated 30-minute webinar. Please note that Obelis clients enjoy many benefits, including the free webinar recording.
Francesca Santacatterina
Publications Department
24.08.2023