Tag: Cosmetic Facility Registration
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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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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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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…
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Modernization of Cosmetics Regulation Act of 2022 (MoCRA): Comprehensive Compliance Guide for Cosmetic Brands
In December 2022, the United States enacted a landmark law that fundamentally reshaped cosmetic regulation—the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This legislation represents the most significant update to cosmetic law in over 80 years and dramatically expanded US FDA authority over cosmetic products marketed in the United States. Before MoCRA, cosmetic regulation…
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Federal Food, Drug, and Cosmetic Act (FD&C Act) and Cosmetics: The Legal Backbone of US Cosmetic Regulation
The United States cosmetic industry operates under a powerful federal law that shapes how products are manufactured, labeled, marketed, and monitored. The Federal Food, Drug, and Cosmetic Act (FD&C Act) forms the foundation of cosmetic regulation in the United States and establishes the authority of the US FDA over cosmetic products. Every cosmetic brand—whether domestic…
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US Cosmetic Law: Regulatory Foundations, Modern Compliance Obligations, and Strategic Pathways for Cosmetic Brands
Entering or expanding within the United States cosmetic market requires more than innovative formulations and attractive packaging. Every cosmetic product sold in the US must align with a complex legal framework designed to protect consumer safety and ensure market transparency. US Cosmetic Law establishes the legal backbone governing how cosmetics are manufactured, labeled, distributed, and…
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US FDA Cosmetic Regulations: Complete Compliance Guide for Cosmetic Manufacturers & Brands
The United States cosmetic market is one of the most highly regulated and competitive industries in the world. Any company planning to manufacture, distribute, import, or sell cosmetic products in the United States must comply with strict US FDA cosmetic regulations. Failure to meet these requirements can lead to warning letters, product seizures, import alerts,…
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Hire XPRO America US FDA Consultants for FDA Direct Portals: Drugs CDER Direct & Cosmetics Direct (MoCRA Compliance)
Introduction: Why FDA Direct Portal Expertise Is Non-Negotiable In today’s highly regulated U.S. market, US FDA compliance is not optional—it is foundational. Drug manufacturers, private label distributors, outsourcing facilities, cosmetic brands, and logistics stakeholders must comply with strict federal registration, listing, and reporting obligations to legally operate in the United States. The FDA Direct Portals, particularly CDER Direct and Cosmetics…