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MoCRA: Facility Listing and Cosmetic Registration with FDA Direct

As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each...more

MOCRA: FDA Draft Guidance on Facility Registration and Product Listing

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

MoCRA: Updates to FDA Safety Substantiation Requirements

As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article, in our continuing series of posts diving into...more

MoCRA: Good Manufacturing Practices – Why Should You Care?

As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each...more

MoCRA: Facility Registration and Product Listing – Where to Begin?

Facility Registration: What Is a Facility and Who Has to Register? Section 607 of MoCRA requires the registration of facilities that manufacture or process cosmetics for distribution in the United States. While this...more

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

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

FDA And TTB Issue Guidance To Increase Hand Sanitizer Production During COVID-19 Outbreak

The Food and Drug Administration and the Alcohol and Tobacco Tax and Trade Bureau (TTB) have both recently issued guidance documents to allow for the increased production of alcohol-based hand sanitizer during the COVID-19...more

Supreme Court Reiterates That Federal Law Preemption For Product Warnings Is A Matter For Judge, Not Jury

On Monday, the United States Supreme Court found that a judge is better suited than a jury to decide if consumers’ tort claims are preempted by federal regulations. In the case, Merck Sharp & Dome, Corp. v. Albreecht, the...more

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