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MoCRA Enforcement is Right Around the Corner! Are You Ready?

The Food and Drug Administration (FDA) is set to start enforcing the requirements of the Modernization of Cosmetics Regulation Act (MoCRA) on July 1, 2024. Manufacturers, distributors, or packers of cosmetic products must comply with the requirements to avoid an enforcement action.

MoCRA Background

MoCRA was passed in 2022 and aims to modernize and strengthen cosmetic regulations in the United States. MoCRA replaced the previous Cosmetic Act, which had not been updated since 1938.

Subsequent to the bill’s passage, the FDA issued regulations implementing the law. In issuing MoCRA regulations, FDA’s aim was to help ensure the overall safety of cosmetic products, and expand the Agency’s ability to trace and track non-compliant products and facilities. MoCRA brings significant changes to the cosmetic industry and regulations under MoCRA impact the entire lifecycle of cosmetics products from manufacturing to marketing.

MoCRA Requirements

New MoCRA requirements include:

FDA registration for cosmetics facilities
Product listings for each cosmetic product
Adverse event reporting
Safety […]

By Jennifer Diaz|2024-06-11T09:59:49-04:00June 11, 2024|Cosmetics, U.S. Food and Drug Administration (FDA)|0 Comments

MoCRA Facility and Product Registration Portal Now Open!
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MoCRA Facility and Product Registration Portal Now Open!
Cosmetics, U.S. Food and Drug Administration (FDA)

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.

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 Jennifer Diaz|2023-12-29T10:44:50-05:00December 29, 2023|Cosmetics, U.S. Food and Drug Administration (FDA)|0 Comments

FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products
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FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products
Cosmetics, FDA Issues, U.S. Food and Drug Administration (FDA)

FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products

On August 7, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance to assist cosmetics companies submitting cosmetic product listings and cosmetic product facility registrations to the agency. The agency characterized the guidance as playing a critical role in helping to ensure the safety of cosmetic products that many consumers use day-to-day.

Background

The growth in the cosmetics industry over the last several years prompted Congress to pass the Modernization of Cosmetics Regulation Act (MoCRA). in 2022. MoCRA modernizes and strengthens cosmetics regulations in the United States and gives the FDA additional authority. Key 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. To assist companies in their MoCRA compliance efforts, the FDA has published new guidance answering key questions and providing recommendations.

Draft Guidance

The draft guidance for industry describes MoCRA requirements for facility registration and product listings, as well as the exemptions for certain small businesses. The guidance explains:

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 document also answers key questions such as what to do if a product is both a drug and a cosmetic product and whether there are fees to submit a registration […]

By Jennifer Diaz|2023-08-11T13:47:05-04:00August 11, 2023|Cosmetics, FDA Issues, U.S. Food and Drug Administration (FDA)|0 Comments

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

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 […]

By Jennifer Diaz|2024-02-02T14:08:08-05:00May 24, 2023|Cosmetics, U.S. Food and Drug Administration (FDA)|2 Comments

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