MoCRA Facility and Product Registration Portal Now Open! 

Essential deadlines under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) come into effect July 1, 2024. MoCRA brings significant changes to the cosmetic industry and will impact your company if you manufacture, distribute, or pack a cosmetic product in the United States.

What is Required Under MoCRA

MoCRA replaces the previous Cosmetic Act, which had not been updated since 1938.

New MoCRA requirements include:

  • FDA registration for cosmetics facilities
  • Product listings for each cosmetic product
  • Adverse event reporting
  • Safety substantiation
  • Compliance with Good Manufacturing Practices (GMPs)
  • Fragrance allergen labeling

MoCRA also gives the FDA new records access and mandatory recall authority. In issuing MoCRA regulations, FDA’s aim is to help ensure the overall safety of cosmetic products, and significantly expand the Agency’s ability to trace and track non-compliant products and facilities.

Registration and Listing Made Easy Through Our Online Portal

Not sure what is required to register a facility or list a cosmetic product? Our online portal will take you through the process step-by-step to ensure you are in compliance.

On our website you can:

  • Register a facility
  • Enlist Diaz Trade Consulting as your U.S. Agent
  • List a cosmetics product
  • Pay registration fees
  • Complete annual renewal
  • Request a UNII code

Get started here. Have questions? Reach out to us at info@diaztradeconsulting.com or call us at 305-400-8458.

Read more about MoCRA:

By |2024-03-15T14:40:32-04:00March 15, 2024|Cosmetics, U.S. Food and Drug Administration (FDA)|Comments Off on MoCRA Facility and Product Registration Portal Now Open! 

MoCRA Update: Final Guidance and Launch of Electronic Submissions Portal

On December 18, 2023, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, an electronic submission portal for product listing and facility registration required under the Modernization of Cosmetics Regulation Act (MoCRA). The agency also issued final guidance with recommendations to assist companies and individuals submitting facility registration and product listing information to the FDA.

Cosmetics Direct

The Cosmetics Direct portal is dedicated exclusively to cosmetic product facility registration and cosmetic product listing electronic submissions to FDA. The portal is an FDA Structured Product Labeling (SPL) authoring tool that contains user friendly data entry forms, performs initial validations, creates and saves the SPL submission, and submits the SPL to FDA for internal processing.

Along with the launch of the portal, the agency also released a portal user guide. The guide provides helpful information on creating submissions through the portal including:

  • Managing accounts and subaccounts
  • How to check submission information and statuses
  • Step-by-step instructions for new registrations
  • Instructions for amending registrations

While the agency prefers electronic submissions, individuals and companies may also submit paper forms which will be offered soon.

Final MoCRA Guidance

The final guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA. The guidance document explains several frequently asked questions including:

  • The statutory requirement to submit cosmetic product facility registrations and product listings
  • Definitions
  • Who is responsible for making the submissions
  • What information to include in the submissions
  • How to make the submissions
  • When to make the submissions

The guidance […]

By |2023-12-29T10:46:38-05:00December 29, 2023|Cosmetics, U.S. Food and Drug Administration (FDA)|Comments Off on MoCRA Update: Final Guidance and Launch of Electronic Submissions Portal
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