FDA Publishes Structured Product Labeling Guide for Cosmetic Products

Recommendation

Thursday, 1 February 2024 9 .00 - 17.00 h

Glass Packaging Systems - Live Online Training
Current & Upcoming Requirements, Challenges and Solutions

The U.S. Food and Drug Administration (FDA) has published an updated structured product labeling (SPL) implementation guide with validation procedures for cosmetic product facility registrations and product listings. The implementation guide can be used to develop SPL authoring tools. In the future, once FDA begins accepting data, users may transmit SPL-formatted submissions through FDA's Electronic Submissions Gateway (ESG) for cosmetic product facility registrations and product listings, mandated by the Modernization of Cosmetics Regulation Act (MoCRA). The agency also intends to make the Cosmetics Direct electronic submission portal available in the future. Cosmetics Direct will be an FDA provided SPL authoring tool that contains user friendly data entry forms, performs initial validations, creates and saves the SPL submission, and submits the SPL to the agency for internal processing without having to use the ESG.

Structured Product Labeling (SPL) for Cosmetics

The SPL serves as a foundational reference for regulatory guidance documents and product labeling content exchange. It enforces control over crucial product information, resulting in a standard for product labeling. The FDA has adopted SPL to enhance patient/customer safety and product usability within its consumer base. In 2005, the agency mandated the use of XML compliant with the SPL standard for electronic submissions. This standard defines the content and structure of product labeling required for submission to the FDA. Consistent structure and standard terminology are employed to enhance the accuracy and reliability of product information. For cosmetic products, amongst others, the following information should be included:

Cosmetic Facility Registration

• Registrant information (Additional Contact)
• Submitter Name and Signature (Legal Authenticator)
• Facility Information
• Facility US Agent
• Parent Company
• Small Business Designation
• Facility Operation
• Responsible Person (Organization)

Cosmetic Product Listing

• Labeler (“responsible person” as per label)
• Registrant
• Responsible person further details
• Facility information
• Facility Product Link
• Submitter Name and Signature (Legal Authenticator)

More information is available in FDA's SPL Implementation Guide with Validation Procedures and Structured Product Labeling Resources.