Cosmetic Compliance
Intelligence & Solutions
User's Guide to FDA Direct (Cosmetics Direct)
Local Title:
CDER Direct User's Guide
Country/Region:
US
Competent Authority:
U.S. Food and Drug Administration (FDA)
Type:
Notice
Status:
In force
Release Date:
2023-12-18
Implementation Date:
2023-12-18
Document
Language Source Title Access
EN
Official User's Guide to FDA Direct (Cosmetics Direct)
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User's Guide to FDA Direct (Cosmetics Direct)
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Summary

On December 18, 2023, the U.S. Food and Drug Administration (FDA) officially announced the launch of the Cosmetic Direct electronic submission portal for cosmetic facility registration and product listing, accompanied by the release of a comprehensive User’s Guide.

The newly released User’s Guide provides detailed explanations and instructions on the relevant steps of account creation and management, facility registration and product listing, etc. on the portal. 

It mainly consists of four parts as shown below:

  1. FDA Direct

  2. Accounts

  3. Submission Information

  4. Cosmetic Registration and Listing

User Guide