Tag: FDA Cosmetic Registration portal
-
USFDA Agent for Cosmetic Registration – Professional Compliance Support for Global Cosmetic Brands
The United States is one of the largest and most competitive cosmetic markets in the world. While the commercial opportunities are significant, cosmetic manufacturers and brand owners must meet strict regulatory expectations before selling products in the United States. For foreign cosmetic manufacturers, one critical requirement stands above all others: appointing a USFDA Agent for…
-
Cosmetic Ingredient Safety: How US FDA Evaluates and Enforces Safe Cosmetic Formulations
Ingredient safety is the foundation of cosmetic compliance in the United States. Every cosmetic product placed on the US market must be safe for its intended use, and the responsibility for ensuring this safety lies with the manufacturer and brand owner. Under the authority of the US FDA and strengthened by the Modernization of Cosmetics…
-
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…
-
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…
-
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…
-
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…
-
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…
-
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…