FDA Cosmetic Facility Registration

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FDA Cosmetic Facility Registration is a regulatory obligation for certain facilities that manufacture or process cosmetic products intended for distribution in the United States. This requirement was formally established through the Modernization of Cosmetics Regulation Act of 2022, commonly referred to as MoCRA.

Under MoCRA, the FDA now has greater oversight over the cosmetic supply chain. One of the central tools introduced by the law is the requirement for cosmetic facilities to provide their registration information to the FDA. This enables the agency to maintain a clear record of the facilities responsible for manufacturing or processing cosmetic products entering the U.S. market.

The concept of FDA cosmetic facility registration focuses on identifying facilities rather than products. The objective is to ensure that the FDA knows where cosmetics are manufactured or processed so that it can perform inspections, monitor compliance, and respond effectively to safety concerns.

This requirement applies to facilities involved in the manufacture or processing of cosmetic products that are distributed in the United States, including both domestic and foreign facilities.

What MoCRA Changed for Cosmetic Facility Registration

Before the adoption of MoCRA, cosmetic facility registration in the United States was largely voluntary through the FDA’s Voluntary Cosmetic Registration Program (VCRP). Companies could choose to register their facilities and list cosmetic products, but this participation was not mandatory.

MoCRA fundamentally changed this approach by introducing mandatory facility registration for certain cosmetic manufacturers and processors.

The law significantly expanded the FDA’s regulatory authority over cosmetics. Facility registration is now part of a broader regulatory framework designed to strengthen cosmetic safety oversight and increase transparency in the cosmetic supply chain.

With MoCRA, the FDA gained several new regulatory powers, including mandatory facility registration, mandatory product listing, adverse event reporting requirements, and enhanced safety substantiation expectations.

The transition from voluntary to mandatory registration represents one of the most significant structural changes to U.S. cosmetic regulation in decades.

Who Must Register a Cosmetic Facility with the FDA

Under MoCRA, a facility must register with the FDA if it manufactures or processes cosmetic products intended for distribution in the United States.

A cosmetic facility is generally defined as an establishment that manufactures or processes cosmetic products. This includes activities such as formulation, mixing, filling, packaging, or labeling of cosmetic products.

Facilities that typically fall under the registration requirement include cosmetic manufacturers producing finished cosmetic products, contract manufacturers producing cosmetics for brands, facilities that fill or package cosmetic products, and certain processing facilities involved in cosmetic production.

Both U.S. and foreign facilities may be subject to FDA cosmetic facility registration if their cosmetic products are distributed in the United States.

Foreign cosmetic facilities exporting products to the U.S. market are therefore also required to register, provided they meet the definition of a cosmetic facility under MoCRA.

Which Facilities Are Exempt from MoCRA Registration

MoCRA provides several exemptions from the FDA cosmetic facility registration requirement. These exemptions are intended to avoid regulatory duplication and to reduce the regulatory burden for certain types of facilities.

Facilities that manufacture or process cosmetic products solely for use in research or evaluation are generally not required to register. Similarly, establishments that manufacture cosmetic products that are also regulated as drugs or medical devices may fall under different regulatory frameworks.

Retail establishments that sell cosmetic products directly to consumers without manufacturing or processing them are also not considered cosmetic facilities under MoCRA.

In addition, certain small businesses may qualify for exemptions depending on their annual sales and the types of cosmetic products they manufacture. However, these exemptions are limited and do not apply to products that present higher potential safety concerns, such as those intended for internal use or certain professional use products.

Because exemptions can depend on specific regulatory definitions and conditions, companies should carefully evaluate whether their activities fall within the scope of FDA cosmetic facility registration requirements.

Information Required for FDA Cosmetic Facility Registration

When registering a cosmetic facility with the FDA, specific information must be submitted to the agency.

The registration generally requires identification of the facility, including the facility name, physical address, and contact details. Companies must also provide information about the facility owner and operator.

Additional information may include the facility registration number if one has previously been assigned, the brand names of cosmetic products manufactured or processed at the facility, and the product categories associated with those cosmetic products.

For foreign cosmetic facilities, the designation of a MoCRA US Agent is also required as part of the registration process.

Providing accurate and complete information is essential because the FDA relies on these data to maintain its database of cosmetic manufacturing facilities and to support regulatory oversight.

How to Register a Cosmetic Facility with the FDA

FDA cosmetic facility registration is typically completed through the FDA’s electronic submission system known as Cosmetic Direct.

Cosmetic Direct is the digital platform provided by the FDA for submitting facility registrations and cosmetic product listings under MoCRA. The system allows companies to submit their registration information electronically, update existing registrations, and maintain compliance with FDA reporting requirements.

Companies must create an account in the system and submit the required facility information through the electronic forms provided.

Although electronic submission is the preferred method, alternative submission methods may exist in certain circumstances. However, the FDA strongly encourages electronic submissions because they allow faster processing and more efficient management of registration data.

Once submitted, the FDA reviews the registration information and assigns a facility registration number.

Role of the MoCRA US Agent for Foreign Cosmetic Facilities

Foreign cosmetic facilities that are required to register with the FDA must designate a MoCRA US Agent.

The MoCRA US Agent acts as the official representative of the foreign cosmetic facility in the United States. The agent serves as the primary point of contact between the FDA and the foreign facility for regulatory communications.

The responsibilities of the US Agent may include facilitating communications between the FDA and the foreign facility, responding to regulatory inquiries, assisting with FDA inspections or requests for information, and supporting compliance with MoCRA obligations.

The designation of a US Agent is a mandatory component of FDA cosmetic facility registration for foreign facilities exporting cosmetic products to the United States.

Because the US Agent plays a central role in regulatory communication with the FDA, companies should carefully select a qualified partner capable of supporting regulatory compliance and responding to FDA requests when necessary.

FDA Cosmetic Facility Registration Deadlines and Updates

MoCRA introduced specific deadlines for facility registration and ongoing registration updates.

Facilities that were already manufacturing or processing cosmetics for the U.S. market when MoCRA entered into force were required to register within the transition timeline established by the FDA.

New cosmetic facilities must register before manufacturing or processing cosmetic products for distribution in the United States.

In addition to the initial registration, facilities must update their registration information within a defined period if certain changes occur. This may include changes to the facility name, address, ownership, or operational status.

MoCRA also requires facility registrations to be renewed periodically to ensure that the FDA’s records remain accurate and up to date.

Maintaining current registration information is therefore an essential part of ongoing MoCRA compliance.

Consequences of Failing to Register with the FDA

Failure to comply with FDA cosmetic facility registration requirements may expose companies to regulatory consequences.

If a facility that is required to register does not do so, the FDA may consider cosmetic products manufactured or processed at that facility to be non compliant under U.S. cosmetic law.

This could lead to enforcement actions such as product refusals, import alerts for foreign manufacturers, warning letters, or other regulatory measures.

Non compliance may also affect the ability of cosmetic companies to distribute products in the United States, particularly if regulatory authorities cannot verify the manufacturing source of those products.

For companies exporting cosmetics to the U.S., proper facility registration is therefore a critical step in ensuring continued market access.

FDA Facility Registration vs Cosmetic Product Listing

MoCRA introduced two separate but complementary regulatory requirements: cosmetic facility registration and cosmetic product listing.

Facility registration focuses on identifying the establishments that manufacture or process cosmetic products.

Product listing, on the other hand, requires responsible persons to submit information about the cosmetic products marketed in the United States.

While these obligations are related, they serve different regulatory purposes. Facility registration provides visibility into the manufacturing infrastructure behind cosmetic products, while product listing gives the FDA information about the specific cosmetic products available on the market.

Both requirements form part of the broader MoCRA compliance framework and are designed to improve the FDA’s ability to monitor cosmetic safety and respond to potential risks.

How FDA Facility Registration Fits into Overall MoCRA Compliance

FDA cosmetic facility registration is only one component of the broader compliance framework introduced by MoCRA.

Companies marketing cosmetics in the United States must also consider other regulatory obligations introduced or reinforced by the law. These include cosmetic product listing, serious adverse event reporting, safety substantiation requirements, and compliance with good manufacturing practices once the FDA finalizes related regulations.

For many cosmetic companies, MoCRA represents a shift toward a more structured and transparent regulatory environment.

Ensuring compliance with facility registration requirements is therefore an essential step in building a complete MoCRA compliance strategy.

Companies that understand the relationship between facility registration, product listing, and other MoCRA obligations will be better positioned to maintain regulatory compliance and avoid potential enforcement risks.

Conclusion

For cosmetic brands, manufacturers, and contract manufacturers operating internationally, understanding and complying with FDA Cosmetic Facility Registration requirements is now a key element of accessing and maintaining the U.S. cosmetic market.

Proper registration, accurate regulatory documentation, and clear communication with the FDA all contribute to ensuring that cosmetic products can be marketed in the United States in full compliance with MoCRA.

Author

Biorius

First Class specialists in cosmetic regulations in Europe, United Kingdom, United States, Canada and in more than 60 countries

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