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FDA Issues New Cosmetics Proposed Rule: Let’s Talk About Talc

Two years after the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the US Food and Drug Administration (FDA) has published the long-awaited proposed rule on talc-containing cosmetics....more

MoCRA Compliance: Key Legal Issues for Fashion Houses with Cosmetics

As we have reported at length, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposed extensive new requirements related to cosmetic products marketed in the United States. As compliance deadlines for these new...more

Deadline to Register Cosmetic Facilities and List Cosmetic Products Fast Approaches

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

FDA Announces Availability of Cosmetics Direct Portal and Publication of Final Guidance on Cosmetic Facility Registration and...

On December 18, the US Food and Drug Administration (FDA) announced the availability of the Cosmetics Direct electronic submission portal and publication of final guidance for industry on cosmetic facility registration and...more

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

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

FDA Delays Enforcement of Cosmetic Facility Registration and Product Listing Requirements

On November 8, the US Food and Drug Administration (FDA) announced its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing. On November 8, the US Food and...more

FDA Announces and Seeks Comments on Cosmetics Direct — Portal for Cosmetic Facility Registration and Product Listing

Last Friday, the US Food and Drug Administration (FDA) announced its newly developed draft electronic submission portal — Cosmetics Direct — to facilitate submissions of cosmetic product facility registrations and product...more

FDA Draft Guidance Provides Further Details on New Cosmetic Product Facility Registration and Product Listing Requirements

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

Modernization of Cosmetics Regulation Act of 2022

On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023. Among the Act’s many provisions is the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which significantly expands the U.S....more

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