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

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 […]
By |2023-05-24T12:27:23-04:00May 24, 2023|Cosmetics, U.S. Food and Drug Administration (FDA)|Comments Off on A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act

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.  […]

By |2023-01-06T11:31:44-05:00January 6, 2023|Best Practices, Cosmetics, Import, International Trade, U.S. Food and Drug Administration (FDA)|Comments Off on Omnibus Bill: What Changes Can You Expect to Cosmetics Regulation?

Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products must be aware of FDA’s various enforcement mechanisms, and more importantly,  how to avoid and/or mitigate such actions.  FDA’s most common enforcement activities include notices of FDA action, warning letters, seizures, voluntary recalls, injunctions, and criminal prosecution.

[…]

By |2021-07-22T11:27:59-04:00May 27, 2021|Cosmetics, E-Cigarette, Food, FSMA, Gluten Free, Import, Import Alert, International Trade, Medical Devices, Pre-compliance, Reasonable Care, Tobacco, U.S. Food and Drug Administration (FDA)|Comments Off on Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

Exporting 201 – Advanced Exporting Webinar 5/22 – RSVP Today!

Whether you are a new or experienced exporter, the next webinar is essential!

  • When do you get to hear from a Board Certified Expert on actual horror stories and when it’s in your best interest to file a Disclosure?

RSVP now to join our Exporting 201 webinar. And don’t forget to check out all of our upcoming webinars!

RSVP TODAY!

[…]

Top Successes of Diaz Trade Law (DTL) & Diaz Trade Consulting (DTC) in 2016!

DTL saved clients MILLIONS of dollars in 2016, below we list a summary of some of our compliance successes!

U.S. Customs & Border Protection (CBP)

  • Assisted an importer in having $434,486.00 worth of goods seized returned to it in a RECORD 24 working days, with a signed settlement agreement with CBP in a record 17 working days!
  • Assisted an importer in having $324,466.00 worth of goods seized for an underlying AES violation returned.
  •  Assisted importers in filing prior disclosures that were accepted by CBP, advising of errors found, and avoiding substantial penalties.
  •  Assisted importers in successfully responding to CBP 28’s and 29’s resulting in close outs, and no further enforcement action by CBP!
  •  Assisted importers in creating and maintaining pre-compliance programs to evaluate intellectual property rights and pre-report merchandise to CBP resulting in expedited entry into the U.S. with no delays or examinations by CBP.

[…]

By |2021-11-09T13:53:53-05:00January 26, 2017|Best Practices, Cosmetics, Cuba, Events, Export, Import, IPR, Trademarks and Logos, Seizures, Speaking, U.S. Bureau of Industry and Security (BIS), U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off on Top Successes of Diaz Trade Law (DTL) & Diaz Trade Consulting (DTC) in 2016!

Register Now to Meet FDA’s Director of Import Operations and Maintenance – November 12, 2015

Do you need to know the current issues affecting importing and exporting for international trade professionals?  What about common compliance issues when importing food, cosmetics, and medical devices?  If you answered yes, you will not want to miss the last of our three-part seminar series that will cover these topics and much more.  Plus, members of supporting organizations, clients of Becker & Poliakoff, and future members and clients, will receive a discount!  Here’s all the information about our upcoming seminar:

[…]

By |2022-07-06T15:13:43-04:00November 6, 2015|Best Practices, Cosmetics, Customs Broker, Food, FSMA, Import, Import Alert, Medical Devices, Speaking, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off on Register Now to Meet FDA’s Director of Import Operations and Maintenance – November 12, 2015

3 Part Compliance Seminar Series You DON’T Want to Miss!

We are excited to announce our upcoming 3 part seminar series on ImportingExporting, and FDA Compliance! Government and private speakers will participate.  
Each seminar will provide resources for new and experienced international trade
professionals including:

[…]

Go to Top