News & Analysis as of

Manufacturers Food and Drug Administration (FDA) Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

Moritt Hock & Hamroff LLP

FDA Updates Requirements for Cosmetics Registration, Listing, and Serious Adverse Event Reporting - Have You Met the July...

Two years ago, Congress greatly expanded the authority of the U.S. Food and Drug Administration (FDA) by enacting the Modernization of Cosmetics Regulation Act (MoCRA). This Act requires companies to register each facility...more

Venable LLP

Event in Review: The Modernization of Cosmetics Regulation Act of 2022

Venable LLP on

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest change to the scope of the U.S. Food and Drug Administration's (FDA) regulatory authority over cosmetics since 1938. ...more

Wiley Rein LLP

Time’s Up! Cosmetic Facilities Must Comply With FDA’s New Registration Requirements by July 1

Wiley Rein LLP on

The July 1, 2024 deadline is fast approaching for cosmetic product manufacturers to comply with new registration and listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Passage of the...more

Arnall Golden Gregory LLP

Magic’s in the Makeup: FDA Modernizes Cosmetic Product Labeling Requirements

“Can’t be good for my health,” a song lyric from Gwen Stefani and No Doubt’s early 2000s single, “Magic’s in the Makeup,” comes to mind when we think of the Food and Drug Administration’s possible motives for recent...more

Bergeson & Campbell, P.C.

FDA Reports That No Asbestos Was Detected in Its 2023 Testing of Talc-Containing Cosmetic Products

The U.S. Food and Drug Administration (FDA) announced on April 5, 2024, the results of its 2023 sampling assignment, testing talc-containing cosmetic products for the presence of asbestos. The testing was conducted using...more

Shook, Hardy & Bacon L.L.P.

FDA Takes Steps to Implement MoCRA

In 2023, the U.S. Food and Drug Administration (FDA) took several steps to implement the Modernization of Cosmetics Regulation Act (MoCRA), which was signed into law in December 2022. The law requires cosmetic manufacturers...more

Blank Rome LLP

FDA Make-Over of Cosmetics Regulations is Not Limited to Cosmetics Businesses

Blank Rome LLP on

The Food and Drug Administration (“FDA”) will begin enforcement of the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) on July 1, 2024. MoCRA represents the biggest regulatory overhaul for the cosmetics industry...more

McGuireWoods LLP

FDA Publishes Two Key Guidance Documents on Cosmetics Facility Registration and Product Listing

McGuireWoods LLP on

The U.S. Food and Drug Administration (FDA) had a busy end of 2023 regarding cosmetics facility registration and product listing, which are now required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)....more

BakerHostetler

FDA Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products

BakerHostetler on

Last month the United States Food and Drug Administration (“FDA”) issued its final guidance (“Guidance”) for the industry on cosmetic product facility registrations and product listings, as required by the Modernization of...more

Morgan Lewis

Register, List, Report, Repeat: FDA Clarifies MOCRA Cosmetics Requirements

Morgan Lewis on

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) brought significant changes for the US Food and Drug Administration’s (FDA’s) regulation of cosmetic products. Recent FDA action, including the issuance of final...more

Beveridge & Diamond PC

MoCRA Update for Starting the Year Off Right

Beveridge & Diamond PC on

Key Takeaways - What Happened: The Food and Drug Administration (FDA) released four updates regarding MoCRA in December....more

Mintz - Health Care Viewpoints

Looking Back and Moving Forward: MoCRA Regulatory Developments Ring in the New Year

A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation...more

Venable LLP

FDA Launches Cosmetics Direct, Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products Under...

Venable LLP on

Last week, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, a new electronic submission portal for the registration and listing of cosmetic product facilities and products under the Modernization of...more

ArentFox Schiff

FDA Announces Updated Instructions for Serious Adverse Event Reporting for Cosmetic Products

ArentFox Schiff on

On December 14, the US Food and Drug Administration (FDA) issued new instructions for cosmetic companies to use when submitting mandatory serious adverse event reports to the agency. As we reported last year, the...more

Locke Lord LLP

FDA Issues Updates as MoCRA ‎Deadlines Approach

Locke Lord LLP on

As the December 29, 2023 deadline for certain aspects of the Modernization of Cosmetics Regulation Act (“MoCRA”) approaches, FDA has finalized its guidance document governing the registration of cosmetic manufacturing...more

Shook, Hardy & Bacon L.L.P.

FDA to Push Back Enforcement of Certain MoCRA Requirements

The U.S. Food and Drug Administration (FDA) has announced that it intends to delay enforcement of cosmetic product facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act...more

Beveridge & Diamond PC

MoCRA Enforcement Pushed Six Months

Beveridge & Diamond PC on

Key Takeaways - What Happened: FDA announced delayed enforcement for MoCRA facility registration and product listing information....more

Vedder Price

The Deadlines for MoCRA are Rapidly Approaching: Are Cosmetic Manufacturers, Packers and Distributors Ready?

Vedder Price on

The Modernization of Cosmetic Regulations Act of 2022 (MoCRA) is part of the Food and Drug Omnibus Reform Act of 2022 (FDORA) that President Biden signed into law late last year. MoCRA greatly expands the FDA’s oversight...more

Locke Lord LLP

FDA Extends Some MoCRA Deadlines

Locke Lord LLP on

On November 8, 2023, FDA issued a Final Guidance entitled Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (“FDA Guidance”) extending some upcoming deadlines set forth in the...more

Husch Blackwell LLP

Legal Insights for Manufacturing: Outlook for 2024

Husch Blackwell LLP on

Our downloadable report, Legal Insights for Manufacturing, explores how the business, legal, and regulatory framework is evolving—and will evolve—to address the large generational shifts taking place. This year, our report...more

Bergeson & Campbell, P.C.

FDA Seeks Comment on Cosmetics Direct and Forms Regarding Registration of Cosmetic Product Facility and Cosmetic Product Listing

On September 15, 2023, the U.S. Food and Drug Administration (FDA) announced that it is seeking comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067)....more

Shook, Hardy & Bacon L.L.P.

FDA Issues Draft Guidance on Cosmetic Product Facility Registrations and Product Listings

The U.S. Food and Drug Administration (FDA) has issued draft guidance on cosmetic product facility registrations and product listings, which are required by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)....more

Husch Blackwell LLP

MOCRA: FDA Draft Guidance on Facility Registration and Product Listing

Husch Blackwell LLP on

As we previously discussed, MoCRA requires cosmetic product manufacturer and processors to register their facilities with the U.S. Food and Drug Administration (FDA). On August 7, 2023, FDA announced that it had published a...more

Arnall Golden Gregory LLP

Not Just for Looks: FDA Publishes Guidance Regarding New Registration and Listing Requirements for Cosmetics

Registration and listing requirements are old news for many FDA-regulated products, but FDA did not have authority to require cosmetic product listings or facility registrations until just recently. FDA had a voluntary...more

Kelley Drye & Warren LLP

FDA’s Draft Guidance on Cosmetics Registration and Listing: A Good Reminder of End-of-Year Deadlines

Earlier this month, in a step toward implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDA issued a draft guidance document titled “Registration and Listing of Cosmetic Product Facilities and...more

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