Dec 2023

FDA’s New MoCRA Portal Is Open. Are You Ready?

As of December 18, 2023, FDA’s Modernization of Cosmetics Regulation Act (MoCRA) portal Cosmetics Direct has officially opened, just over a week before the December 29 statutory deadline.

Cosmetics companies can now move quickly to comply with MoCRA and submit any required documentation. 

Read on to learn more about the new FDA MoCRA platform and how it works. 

What You Need To Know About the MoCRA Portal

Cosmetics Direct, FDA’s platform for MoCRA compliance, performs several crucial functions that helps cosmetics facilities meet new requirements for facility registration and product listings. 

Enables Cosmetic Facility Registration

Under MoCRA, cosmetics manufacturers and processors must register their facilities with FDA and renew their registration every two years. All initial facility registrations, registration updates and changes, and renewals will now be made through the Cosmetics Direct portal.

To register or renew your facility registration, go to FDA Direct and create a new account for CDER Direct (drugs), Cosmetics Direct, or a combined account for both drug and cosmetics submissions.

You will then be directed to choose the appropriate submission (Registration of Cosmetics Product Facility) and create an initial submission or import an existing one to the portal.

Streamlines Product Listings

MoCRA now requires a Responsible Person (RP) to list each cosmetic product marketed within the U.S. with FDA, which includes product ingredients. Updates to product listings must also be made annually.

According to FDA, an RP means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label. Note that this definition differs from the EU’s definition of a responsible person.

To list products on the new FDA MoCRA portal, log in to your Cosmetics Direct account and choose “Cosmetic Product Listing” under Submissions. You’ll then be directed to create an initial product listing or import an existing one. You can also make changes to or discontinue listings within the portal. 

New SPL Guidelines 

Cosmetic facilities will be required to submit facility registrations in Structured Product Labeling (SPL) format on the new MoCRA portal. Responsible Persons will also need to submit any new or updated product listings in SPL format as well. This is the same electronic submission process used to register drug establishments and list drug products with FDA. 

While this is meant to streamline FDA cosmetics and drug submissions, working with SPL format may be a significant shift for many cosmetic companies. 

On December 14, FDA released updates to their 273-page SPL Implementation Guide, which was first released in October and updated in November 2023. The most recent updates include further guidance around cosmetics product facility registrations and product listings included within the SPL framework.

Upcoming MoCRA Deadlines 

Due to delays in launching Cosmetic Direct, FDA has made several recent changes to upcoming deadlines. Here are the upcoming deadlines to keep in mind as you prepare for MoCRA compliance. 

  • Cosmetic facility registration: December 29, 2023, remains the statutory deadline but FDA has delayed enforcement until July 1, 2024, effectively providing a 6-month extension. 
  • Cosmetic product listings: Still due on December 29, 2023, but like facility registration, FDA enforcement has been delayed until July 1, 2024. 
  • Adverse event record keeping and reporting: Cosmetics companies must begin complying with new MoCRA adverse event requirements by December 29, 2023, with no enforcement delays. 
  • Additional requirements: Most other statutory requirements such as safety substantiation, professional use labeling, and records access, will be enforced beginning December 29, 2023. 

Guidance on Good Manufacturing Processes (GMPs), fragrance allergen labeling, and standardized asbestos testing have yet to be announced by FDA.

Prepare for MoCRA Compliance Today

Registrar Corp has helped thousands of cosmetics companies maintain compliance and streamline operations with our cosmetics services and software platform, Cosmetri. 

Our customers can leverage Cosmetri to comply with MoCRA through our Product Manager and Cosmetri GMP product platforms. R&D and regulatory professionals can take advantage of our Product Manager’s compliance pack, which includes a regulatory and ingredients database from 55+ countries. With Cosmetri GMP, users can digitally store GMP documents, conduct internal audits, and more. 

Get in touch with us to see how Cosmetri can help you comply with MoCRA.

Registrar Corp also offers a range of solutions for cosmetics facilities to help them comply with new MoCRA regulations. These include: 

  • FDA facility registration 
  • Product listings 
  • Adverse event reporting 
  • Label & ingredient review 
  • And more 

With extensive experience submitting drug registrations and listings in SPL format, our regulatory specialists can confidently guide you through MoCRA portal submissions. 

Learn more about how Registrar Corp can support your cosmetics company today.

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