Tag: Is FDA approval required for cosmetics?
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Cosmetic Adverse Events: US FDA Requirements, MoCRA Rules, and Compliance Obligations
Cosmetic safety does not end once a product reaches the market. Under United States law, cosmetic companies are legally responsible for monitoring, documenting, and reporting cosmetic adverse events. With the enactment of the Modernization of Cosmetics Regulation Act (MoCRA), adverse event reporting has become a mandatory and enforceable requirement under the authority of the US…
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Cosmetic Product Claims: How US FDA Regulates What You Can and Cannot Say
Cosmetic product claims are one of the most common sources of regulatory violations in the United States. While cosmetic labels and marketing materials are powerful tools for attracting consumers, they are also closely regulated by the US FDA. Claims that overstep legal boundaries can cause a cosmetic to be misbranded, reclassified as a drug, or…
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Cosmetic Product Safety Substantiation: Building Scientific Proof of Safety Under MoCRA
Cosmetic safety in the United States is no longer based on informal assurances or internal opinions. With the enactment of the Modernization of Cosmetics Regulation Act (MoCRA), cosmetic companies are now legally required to maintain adequate safety substantiation for every cosmetic product marketed in the United States. Under the authority of the US FDA, cosmetic…
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US FDA Mandatory Cosmetic GMP: What MoCRA Means for Cosmetic Manufacturing Compliance
The regulatory expectations for cosmetic manufacturing in the United States have changed dramatically with the passage of the Modernization of Cosmetics Regulation Act (MoCRA). One of the most important outcomes of MoCRA is the clear movement toward mandatory Cosmetic Good Manufacturing Practices (GMP) under the authority of the US FDA. While cosmetic GMP was historically…
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Annual Cosmetic Product Listing Update: Keeping Product Data Current Under MoCRA
The Modernization of Cosmetics Regulation Act (MoCRA) established cosmetic product listing as a mandatory requirement for all cosmetic products marketed in the United States. Beyond initial listing, MoCRA also requires companies to perform an annual cosmetic product listing update with the US FDA. An annual update confirms that product information on file remains accurate and…
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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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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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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 FDA Cosmetic Registration: Complete Guide for Cosmetic Brands Selling in the US Market
By XPRO America – US FDA Consultancy The global cosmetic industry is growing rapidly, but when it comes to selling cosmetics in the United States, FDA cosmetic registration is a critical compliance requirement that brands cannot ignore. Many cosmetic manufacturers and brand owners believe cosmetics are “free from regulation,” only to face shipment delays, buyer…