Cosmetics Direct: How the New FDA Portal Changes Industry

Written by Registrar Corp

How Does Cosmetics Direct, the New FDA Portal Work?

Cosmetic companies will submit facility registrations and product listings using the Structured Product Labeling (SPL) format, the same framework and process available to register an establishment and list a drug with FDA. 

In October, FDA released a guideline for SPL implementation and validation. The 275-page guide describes Cosmetic 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. 

An Update to MoCRA Compliance Deadlines

The statutory deadline for facility registration and product listing is still marked for December 29, 2023. However, FDA will not begin enforcement until July 1, 2024, providing a six-month extension to facilities that began manufacturing or processing cosmetics products before and after December 29, 2023. 
 
It is important to remember, this delay is specific to facility registration and product listing only. 

All other statutory requirements that go into effect on December 29, 2023 will be enforced (including adverse event record keeping & serious adverse event reporting, safety substantiation, professional use labeling, records access, etc).

Get MoCRA Compliance Done the Right Way

The passage of MoCRA has already made cosmetic compliance more complex than ever. For those companies where SPL submission is new territory, the FDA portal — Cosmetics Direct — and its use, can seem outright intimidating.

Registrar Corp can lift the burden and stress of handling complicated XML and validation so you can focus on the initiatives that matter most to your business.

We’ve spent the last 20 years assisting over 30,000 businesses each year across 175+ countries navigate the complexities of FDA Compliance. We can help you, too.

Discover how we make cosmetic compliance quick and easy, today.

Content provided by Registrar Corp. References are provided for informational purposes only. The information is the opinion of the author and its appearance in this blog is not considered an endorsement by the SCC. SCC makes no representation, express or implied, regarding the accuracy, adequacy, validity, reliability, availability or completeness of any information contained therein.