Tag: US FDA cosmetic compliance
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Form FDA 5066 and Cosmetic Facility Registration: Practical Guidance Under MoCRA
The implementation of the Modernization of Cosmetics Regulation Act (MoCRA) introduced a mandatory framework for cosmetic facility registration with the US FDA. At the center of this requirement is Form FDA 5066, the official submission mechanism used to register cosmetic manufacturing and processing facilities. Form FDA 5066 is not simply an administrative form. It represents…
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Serious Adverse Event Reporting for Cosmetics: US FDA MoCRA Compliance Explained
The Modernization of Cosmetics Regulation Act (MoCRA) has significantly strengthened post-market safety oversight for cosmetic products in the United States. One of the most critical obligations introduced under MoCRA is mandatory serious adverse event reporting to the US FDA. Cosmetic companies are now legally required to report serious adverse events associated with their products within…
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Responsible Person for Cosmetics Under US FDA: Legal Role, Duties, and Compliance Requirements
The Modernization of Cosmetics Regulation Act (MoCRA) introduced a major structural change in how cosmetic products are regulated in the United States. One of the most important concepts established under MoCRA is the designation of a Responsible Person for cosmetic products. The Responsible Person is the legally accountable party for ensuring that each cosmetic product…
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FDA MoCRA Cosmetic Registration: Complete Compliance Guide for Cosmetic Brands | XPRO America
The U.S. cosmetic regulatory landscape has undergone the most significant transformation in decades with the implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). For cosmetic manufacturers, brand owners, private-label companies, and foreign exporters targeting the United States market, FDA MoCRA Cosmetic Registration is no longer optional—it is a legal requirement. This article explains MoCRA in…