News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Cosmetics

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

ArentFox Schiff

Deadline to Register Cosmetic Facilities and List Cosmetic Products Fast Approaches

ArentFox Schiff on

Companies subject to the requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) should take note that the deadline to register cosmetic facilities and list cosmetic products is fast approaching on July...more

K&L Gates LLP

Litigation Minute: Beauty From Within and the Confusing Claims Landscape

K&L Gates LLP on

What You Need To Know In A Minute Or Less - The current industry trend “beauty from within” refers to a focus on wellness—namely physical, mental, and lifestyle—and its impact on beauty. Oral supplements that consumers can...more

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Perkins Coie

Q4 2023 | Food and CPG Legal Trends

Perkins Coie on

PERKINS COIE IS PLEASED TO PUBLISH ITS Q4 FOOD AND CPG LEGAL TRENDS REPORT. This report is a bite-sized version of our annual year in review, providing timely insights on trends so far this year. In Q4 2023, the Consumer...more

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2023

Harris Beach PLLC on

From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...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

BCLP

Part 3 in MoCRA Series: FDA Guidance on Cosmetic Product Listings

BCLP on

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. As we...more

Perkins Coie

FDA Publishes Draft Guidance For Submitting Cosmetic Product Facility Registrations and Product Listings Under MoCRA

Perkins Coie on

The U.S. Food and Drug Administration (FDA) issued draft guidance on August 7, 2023, clarifying new requirements for cosmetic facility registrations and product listings under the Modernization of Cosmetics Regulation Act of...more

ArentFox Schiff

FDA Draft Guidance Provides Further Details on New Cosmetic Product Facility Registration and Product Listing Requirements

ArentFox Schiff on

Earlier this week, the US Food and Drug Administration (FDA) issued draft Q&A guidance entitled “Registration and Listing of Cosmetic Product Facilities and Products,” which clarifies the agency’s expectations regarding the...more

Mintz - Health Care Viewpoints

FDA Publishes Draft Guidance on Cosmetic Product Facility Registration and Cosmetic Product Listing

On August 7, 2023, the Food and Drug Administration (FDA) published Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (the Draft Guidance), which provides much-needed...more

Venable LLP

Prepare Now for the New FDA Requirements for Cosmetics Companies

Venable LLP on

Thanks to the Food and Drug Omnibus Reform Act (FDORA), cosmetic companies will soon be subject to new requirements for registration, product listing, disclosure of ingredients, adverse event reporting, safety substantiation,...more

Husch Blackwell LLP

MoCRA: Is my product a “cosmetic” and who is my “responsible person”?

Husch Blackwell LLP on

Am I making a “cosmetic product”? If you are a manufacturer, packer, importer, or distributor, the first question you should be asking is whether your product falls under the definition of a “cosmetic product,” which...more

Morgan Lewis - Well Done

Cosmetics Regulations Getting a Makeover: FDA Announces Listening Session on Cosmetic Product GMPs

FDA recently published a Federal Register notice announcing a public listening session on good manufacturing practices (GMPs) for cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which...more

Davis Wright Tremaine LLP

A Makeover for the Cosmetic Industry: Legal Style

On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023 (H.R. 2617), which by its name does not appear to have anything to do with cosmetics. However, buried in the approximately 1,650...more

Rivkin Radler LLP

Modernization of Cosmetics Regulation Act of 2022

Rivkin Radler LLP on

FDA WILL HAVE EXTENSIVE AUTHORITY TO REGULATE COSMETICS- Under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321(i), “cosmetics” are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on,...more

Harris Beach PLLC

Modernization of Cosmetics Regulation Act of 2022 Signals New Era of FDA Oversight

Harris Beach PLLC on

For the first time since the passage of the Food, Drug and Cosmetic Act in 1938, the Federal cosmetics law has been substantially updated with the passage of the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”)....more

Foley & Lardner LLP

Modernization of Cosmetics Regulation Act of 2022: What You Need to Know

Foley & Lardner LLP on

On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA significantly changes the current regulatory...more

Foley Hoag LLP

Congress Adds Some Teeth to FDA’s Authority to Regulate Cosmetics

Foley Hoag LLP on

The Food and Drug Administration (FDA) now has additional regulatory authorities over cosmetics, thanks to the Food and Drug Omnibus Reform Act (FDORA). FDORA was a part of the Consolidated Appropriations Act, 2023 (the...more

Wilson Sonsini Goodrich & Rosati

A Much-Needed Makeover: Congress Signs Updates to Cosmetic Regulations

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), signed into law on December 29, 2022, as part of the year-end Consolidated Appropriations Act, 2023, added significant new requirements for manufacturers,...more

Latham & Watkins LLP

FDA Omnibus Reform Act: Examining the Policy Changes

Latham & Watkins LLP on

The Act introduces key reforms to the FDA regulatory framework relating to drugs, biological products, and cosmetics, among others. On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023...more

MoFo Life Sciences

Congress Expands FDA Authority Over Cosmetics Regulation

MoFo Life Sciences on

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed by the U.S. Congress as part of the omnibus Consolidated Appropriations Act enacted on December 29, 2022 and will grant the U.S. Food and Drug...more

Akin Gump Strauss Hauer & Feld LLP

Congress’ Year-End Appropriations Package Brings FDA Legislative Changes, Leaves Unresolved Policy Issues

In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes. Although the Senate Health, Education, Labor and Pensions...more

Mintz - Health Care Viewpoints

FDA’s Holiday Present from Congress: Bipartisan Reforms to the Accelerated Approval Framework, Long-Awaited Cosmetic...

On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act for 2023, colloquially referred to as the omnibus funding bill, that includes a similarly expansive and diverse piece of legislation...more

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