On December 18, 2023, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, the electronic submission portal for facility registration and product listing required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and published a User Guide for the portal.[1] Cosmetics Direct contains user friendly data entry forms, performs initial validations, creates and saves the structured product labeling (SPL) submission, and submits the SPL to FDA.
The agency also issued final guidance with recommendations and instructions to assist those who are submitting facility registration and product listing information to the FDA. Among other things, this guidance covers who is responsible for making submissions, how and when to make submissions, and the information that must be included.[2]
