Yesterday FDA published an updated Structured Product Labeling (SPL) Implementation Guide with Validation Procedures, including updates to cosmetics product facility registrations and product listings that are now included within the SPL framework.
Yesterday’s release updates the SPL Implementation Guide published by FDA on October 13, 2023, which included facility registrations and product listings within the SPL framework, and described the soon-to-be-released Cosmetics Direct electronic submission portal function as an SPL authoring tool intended to feature user friendly data entry forms, perform initial validations, create and save SPL submissions, and submit the SPL forms to FDA for internal processing.
Noteworthy changes to the required technical conformance criteria include:
-
- Clarification of initial versus updated cosmetic product coding;
- Clarification of coding requirements for human OTC drugs that are also cosmetic products;
- Clarification between “leave-on” versus “rinse-off” product coding, unless the document type is a Cosmetic Facility Registration;
- Clarification of cosmetic product category and cosmetic product facility codes;
- Reclassification of “feminine deodorants” as “other personal cleanliness products”;
- Clarification of market status coding as to discontinued or soon-to-be discontinued cosmetic products; and
- Replacement of “Registrant” information with “Authorized Agent” information.
FDA has not yet announced when it expects the Cosmetics Direct portal to go live, but anticipates it being available for companies to register facilities and list products sometime before year end.