Cosmetics Direct

Overview: Cosmetics Direct is an electronic submission portal designed for the registration and listing of cosmetic product facilities and products. It facilitates compliance with FDA regulations and enhances product safety and usability.

Updates as of 29-Jul-2024:

1. Discontinuation Feature:
   1. Responsible persons can now discontinue cosmetic products that were previously listed in Cosmetics Direct but are no longer on the market.
2. Relisting Feature:
   1. Responsible persons have the option to relist cosmetic products that were previously discontinued and are being reintroduced to the market.

Key Information:

• FDA Structured Product Labeling (SPL):
  • SPL is a standardized document approved by Health Level Seven (HL7) for regulatory guidance and product labeling content exchange.
  • The FDA uses SPL to improve patient safety, product usability, and regulatory consistency.
• XML Compliance:
  • Since 2005, the FDA has required XML compliant with the SPL standard for electronic submissions, ensuring structured and consistent product labeling.
• Cosmetics Direct Portal:
  • Launched by the FDA, this portal supports electronic registration and listing of cosmetic product facilities and products.
  • The portal aligns with the Modernization of Cosmetics Regulation Act of 2022, enhancing regulatory efficiency and compliance.

Purpose and Benefits:

Cosmetics Direct helps streamline the registration process, maintain accurate product listings, and support regulatory compliance with up-to-date features for product discontinuation and relisting.

Source: https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products/cosmetics-direct