On 15 September 2023, the US FDA launched a consultation on Cosmetics Direct, the new notification portal for facility and product registrations under the Modernization of Cosmetics Regulation Act (MoCRA). The Agency invites comments on the screenshots of the new system that have been made available.
The FDA consultation covers three points:
• The draft Cosmetics Direct electronic submission portal
• The form FDA 5066, for facilities registration
• The form FDA 5067, for products registration
“Cosmetics Direct includes the required registration and listing submission information from the paper forms in a standard electronic format,” the FDA says. “This will help the respondent organize their registration and listing submission to include the information needed for FDA and will give the respondent access to their previous Cosmetic Direct registrations and listing submissions.”
FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency. But respondents that prefer to submit paper registrations and listings will still have the option to do so.
The FDA has provided annotated screenshots to enable interested parties to visualise the system:
• For Cosmetics Direct
• For Form FDA 5066
• For Form FDA 5067
Sources
• FDA Roundup, FDA, Press announcements, 19 September 2023
• Registration & Listing of Cosmetic Product Facilities and Products, FDA, 15 September 2023
