Tag: US FDA consultancy
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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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US FDA Cosmetic Registration Process: Step-by-Step Compliance Roadmap for Cosmetic Companies
The regulatory environment for cosmetics in the United States has undergone a major transformation with the implementation of the Modernization of Cosmetics Regulation Act (MoCRA). One of the most important outcomes of MoCRA is the establishment of a mandatory cosmetic registration process enforced by the US FDA. Today, cosmetic registration is no longer a voluntary…
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Cosmetics Direct: US FDA’s Centralized Platform for Cosmetic Regulatory Compliance
The Modernization of Cosmetics Regulation Act (MoCRA) has transformed how cosmetic products are regulated in the United States. To support these changes, the US FDA introduced a centralized electronic submission system known as Cosmetics Direct. This platform is designed to receive, manage, and process cosmetic regulatory submissions required under MoCRA. Cosmetics Direct serves as the…
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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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Cosmetic Product Listing Under MoCRA: Mandatory US FDA Compliance for Cosmetic Brands
The Modernization of Cosmetics Regulation Act (MoCRA) introduced a new regulatory era for cosmetic companies selling products in the United States. One of the most critical obligations created by MoCRA is cosmetic product listing with the US FDA. Cosmetic product listing is no longer voluntary. Every cosmetic product marketed in the US must now be…
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Cosmetic Facility Registration Under MoCRA: Complete US FDA Compliance Guide
The Modernization of Cosmetics Regulation Act (MoCRA) introduced the most significant regulatory changes to the United States cosmetic industry in decades. One of its cornerstone provisions is the requirement for cosmetic facility registration with the US FDA. This mandatory obligation applies to both domestic and foreign facilities that manufacture or process cosmetic products for distribution…
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MoCRA Compliance Requirements: Essential Regulatory Obligations for Cosmetic Companies
The cosmetic regulatory landscape in the United States has entered a new era. With the implementation of the Modernization of Cosmetics Regulation Act (MoCRA), cosmetic manufacturers, brand owners, private labelers, and importers are now subject to enforceable federal requirements. MoCRA transformed many previously voluntary practices into mandatory legal obligations under the authority of the US…