Cosmetics

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:

A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act

In recent years, the cosmetics industry has experienced exponential growth, with new products being introduced almost daily. The average American consumer uses six to 12 cosmetics products daily. This growth has resulted in a need for more comprehensive regulation of cosmetic products to ensure consumer safety. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is a new law that aims to modernize and strengthen cosmetic regulations in the United States.

MoCRA was signed into law on January 1, 2022, and replaces the previous Cosmetic Act, which had not been updated since 1938. MoCRA brings significant changes to the cosmetic industry and regulations under MoCRA will impact the entire lifecycle of cosmetics products from manufacturing to marketing.

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.

Facility Registration and Product Listing 

Cosmetic facilities must register with the FDA (deadline has been extended to July 1, 2024) and renew their registration every two years thereafter . The term “facility” means any establishment that either manufactures or process cosmetic products distributed in the United States. New facilities must be registered within 60 days after they start manufacturing cosmetics.

The FDA may suspend a facility’s registration if the FDA determines […]

Omnibus Bill: What Changes Can You Expect to Cosmetics Regulation?

On December 22, 2022, U.S. House and Senate leaders passed the long-awaited $1.7 trillion FY2023 omnibus spending bill. This blog provides information on the significant changes to cosmetics regulation with the passage of the Omnibus bill and the Food Drug and Cosmetic Act amendments. We encourage you to contact Diaz Trade Law to assess the implications of the significant changes.  […]

Title

Go to Top