FDA Publishes SPL Guide for MoCRA Facility Registration and Product Listings

On October 13, 2023 he FDA announced that two of the requirements set forth in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)— facility registration and product listing—will be included as part of the Structured Product Labeling (SPL) framework. SPL is a document formatting standard adopted by FDA for exchanging product-related information. 

The FDA previously developed Cosmetics Direct, a draft electronic portal for submissions under MoCRA. Companies who will use Cosmetics Direct may submit facility registration information and/or product listings by importing an SPL document, which contains user friendly data entry forms, performs initial validation, creates and saves the SPL submission, and submits the SPL document to FDA for internal processing.

In order to assist those who will be using and uploading SPL documents, the FDA also published a SPL Implementation Guide with technical conformance criteria for SPL documents. According to this Guide, importing an existing SPL document will be useful for bulk submissions, and users will be able to copy a successfully uploaded SPL document as a starting point for their own submission.