A businesswoman mixes cosmetics as she contemplates the use of Cosmetics Direct, the FDA’s new electronic cosmetics portal for facility registration and product listings in SPL format.
Author

Jaclyn Bellomo

Senior Director of Cosmetic Science and Regulatory Affairs

Previewing FDA’s Cosmetic Direct Portal and SPL Guidelines

Sep 27, 2023

To meet the December 29, 2023 deadline, cosmetic companies prepare to comply with new Modernization of Cosmetics Regulation Act (MoCRA) requirements.  

FDA continues to share guidance on the new electronic submission portal, Cosmetics Direct, and Structured Product Labeling (SPL) format.

Cosmetics Direct Portal 

In September 2023, FDA released a new 81-page document Electronic Submission Portal Screenshots for Cosmetics. This document provides the user journey for facility registration and cosmetic product listing as required by MoCRA.

It also shows validation failures that can occur when submitting your information.  

FDA has done a fantastic job educating the industry on what to expect from MoCRA. This preview helps companies determine whether they’re capable of handling portal submissions or will need outside expertise.

FDA began accepting comments on the newly developed draft electronic submission portal (Cosmetics Direct) and paper forms. The deadline to submit a comment was October 18th, 2023. 

A Peek Into Structured Product Labeling (SPL) Format

The new Cosmetics Direct portal highlights the SPL format, a key component of structured product labeling software, that will be required for all cosmetic submissions. For those cosmetic companies where the SPL format is new territory, the examples, XML formatting, and validating can seem complicated.  

Before the screenshots were released, the only information available to the industry was in the Draft Guidance for Industry. This guidance stated that you should submit registration and listing data in the SPL format and gave these details: 

“Cosmetic product facility registration and product listing will be available using the same electronic submission process available to register an establishment and list a drug with FDA. This will help to streamline the process of submitting registration and listing information for cosmetics facilities and products for entities that also submit drug establishment and listing information.”

 

 

SPL Implementation Guide and Validation Procedures 

In October, FDA released a guideline for SPL implementation and validation. The 275-page guide describes Cosmetics Direct as a user-friendly SPL authoring tool that will perform initial validations, create and save SPL submissions, and submit them to FDA.  

On November 14, FDA updated the SPL Implementation Guide to include additional updates to the cosmetics product facility registrations and product listings included within the SPL framework. 

Upcoming MoCRA Compliance Deadlines  

FDA has yet to announce the exact launch date of the Cosmetics Direct submission portal. But it will be launched in time for facilities to meet the upcoming December 29, 2023 deadline. 

FDA did announce a delayed enforcement date of July 1, 2024, or six months after the December 29 deadline. This update acknowledges the complexities of SPL submissions and gives cosmetics facilities additional time to comply with requirements.  

 The extension applies to cosmetics facilities that began manufacturing or processing cosmetics products after December 29, 2022. Instead of having to register by the December deadline, they will just need to complete registration before July 1.  

Companies that first began marketing cosmetic products after December 29, 2022 will also have an additional six months before FDA enforces MoCRA listing requirements. 

Registrar Corp Can Help  

With Registrar Corp’s extensive experience submitting FDA drug listings in the SPL format, cosmetic companies trust Registrar Corp to assure they comply with FDA’s new cosmetic requirements under MoCRA and assist them with Cosmetics Direct submissions.  

View the entire document previewing the new cosmetics portal and discover what Registrar Corp can do for your company to comply with the new regulations.


Frequently Asked Questions About Cosmetics Direct

Author


Jaclyn Bellomo

Senior Director of Cosmetic Science and Regulatory Affairs

A seasoned expert on the cosmetic industry, Jaclyn's deep understanding and insights on cosmetic regulations brought on with the passage of the Modernization of Cosmetics Regulation Act (MoCRA) are unmatched. Her experience and reputation throughout the global cosmetic industry helps companies worldwide meet the newly enacted FDA regulations under MoCRA.

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