Resources/MoCRA Facility Registration: FDA Requirements for Cosmetics

MoCRA Facility Registration: FDA Requirements for Cosmetics

Published October 14, 2026

Disclaimer: The information provided in this guide is for educational and regulatory context purposes only and does not constitute formal legal advice. Compliance requirements can vary based on formulation, regional authority updates, and specific product claims. Consult a certified regulatory affairs professional or specialized legal counsel for official filings.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a pivotal shift in U.S. cosmetic oversight, introducing new federal requirements for cosmetic product safety and labeling. Among its most impactful provisions are the mandatory registration of cosmetic facilities with the U.S. Food and Drug Administration (FDA), a critical step for ensuring regulatory adherence for manufacturers, processors, and packers operating in the cosmetics industry.

Defining a Cosmetic Facility Under MoCRA

Under MoCRA, a "cosmetic facility" is broadly defined as any establishment that manufactures or processes cosmetic products for distribution in the United States. This includes operations involved in the preparation, compounding, assembly, filling, or packaging of cosmetic products. Understanding whether an operation falls under this definition is the first step toward compliance, as it dictates the applicability of the registration mandate.

Essential Information for Facility Registration

Facilities subject to MoCRA must submit specific information to the FDA as part of their registration. This data enables the agency to maintain an accurate registry of establishments involved in the cosmetic supply chain, enhancing oversight and public health protection.

Facility name and physical address.
All brand names under which cosmetic products manufactured or processed in the facility are marketed.
The cosmetic product category or categories (e.g., skin care, hair care, makeup) manufactured or processed at the facility.
The name and contact information of the U.S. agent or contact person for foreign facilities.
Registration number of the responsible person for each cosmetic product manufactured or processed at the facility, if applicable.

Registration Deadlines and Biennial Renewal Obligations

MoCRA established initial deadlines for existing cosmetic facilities to register, with new facilities required to register within a specified timeframe after commencing operations. Crucially, registration is not a one-time event; facilities must renew their registration biennially. This ongoing requirement ensures that the FDA's database remains current, reflecting any changes in facility information or operational status. Failure to meet these deadlines or maintain current registration can lead to regulatory action.

Exemptions and Key Considerations

While MoCRA's facility registration requirements are extensive, certain entities may qualify for exemptions. For instance, some small businesses meeting specific criteria may be exempt from facility registration, though they may still be subject to other MoCRA provisions. Additionally, establishments that only perform labeling, relabeling, packaging, repackaging, holding, or distributing of cosmetic products, but not manufacturing or processing, are generally not considered cosmetic facilities for registration purposes. It is vital for businesses to carefully assess their operations against the full text of the regulation to determine their specific obligations.

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