FDA Cosmetic Product Listing: Complete Guide to MoCRA Product Listing Requirements

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FDA Cosmetic Product Listing is a regulatory requirement introduced under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which significantly expanded the oversight of cosmetic products in the United States. Under this law, companies responsible for cosmetic products marketed in the United States must submit detailed product information to the U.S. Food and Drug Administration (FDA).

The purpose of FDA Cosmetic Product Listing is to provide the FDA with greater visibility into cosmetic products distributed in the U.S. market. By requiring companies to submit information about their cosmetic products and ingredients, the FDA can improve regulatory monitoring, enhance product safety oversight, and more efficiently respond to potential public health concerns.

FDA Cosmetic Product Listing is one of the central compliance obligations established by MoCRA, alongside FDA Cosmetic Facility Registration, serious adverse event reporting, and enhanced cosmetic safety responsibilities for companies operating in the U.S. cosmetic market.

Understanding how FDA Cosmetic Product Listing works and who must comply is essential for manufacturers, brand owners, and importers seeking to place cosmetic products on the U.S. market in compliance with federal law.

What Is FDA Cosmetic Product Listing

FDA Cosmetic Product Listing is the regulatory process through which cosmetic companies must submit information about each cosmetic product marketed in the United States to the FDA.

This obligation was introduced by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to create a more structured regulatory framework for cosmetic oversight.

Under MoCRA, cosmetic companies must provide the FDA with key information about their products, including product identity, ingredient details, and the identity of the Responsible Person associated with the product.

The objective of FDA Cosmetic Product Listing is to enable the FDA to maintain an updated record of cosmetic products placed on the U.S. market. This regulatory visibility supports the FDA’s ability to:

monitor the cosmetic marketplace
identify potential safety issues
conduct regulatory inspections and investigations
respond to serious adverse event reports

FDA Cosmetic Product Listing forms a core element of MoCRA’s broader effort to modernize cosmetic regulation in the United States.

Who Must Submit FDA Cosmetic Product Listings

Under MoCRA, the obligation to submit FDA Cosmetic Product Listings falls on the Responsible Person for the cosmetic product.

MoCRA defines the Responsible Person as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label in accordance with the Federal Food, Drug, and Cosmetic Act.

In practice, the Responsible Person is often:

the cosmetic brand owner
a private label company
a manufacturer whose name appears on the product labeling
a distributor listed on the product label

The Responsible Person is legally responsible for ensuring that each cosmetic product marketed in the United States is properly listed with the FDA.

Although manufacturers may assist in preparing regulatory documentation, the legal responsibility for submitting the FDA Cosmetic Product Listing ultimately remains with the Responsible Person identified on the product label.

For imported cosmetic products, the foreign manufacturer or brand owner must ensure that a Responsible Person is designated for the product in the United States.

What Information Must Be Included in an FDA Cosmetic Product Listing

When submitting an FDA Cosmetic Product Listing, the Responsible Person must provide specific information required by MoCRA.

Although the FDA provides the electronic submission system used for listings, the regulatory framework specifies the categories of information that must be included in the submission.

Typical information included in an FDA Cosmetic Product Listing includes:

the name of the cosmetic product
the cosmetic product category or categories
the name and contact details of the Responsible Person
the facility registration number of the manufacturing facility
a list of ingredients present in the product
any relevant product identifiers used in commerce

The ingredient information submitted in the product listing must reflect the ingredients used in the cosmetic product formulation. In general, ingredients are reported using recognized ingredient names, such as those commonly used in cosmetic ingredient labeling.

The FDA uses the information provided through FDA Cosmetic Product Listings to build and maintain a registry of cosmetic products placed on the U.S. market.

How FDA Cosmetic Product Listing Works Under MoCRA

The Modernization of Cosmetics Regulation Act of 2022 introduced a system in which FDA Cosmetic Product Listing operates alongside FDA Cosmetic Facility Registration. These two regulatory obligations are closely connected but serve different purposes.

FDA Cosmetic Facility Registration requires facilities that manufacture or process cosmetic products for distribution in the United States to register with the FDA. FDA Cosmetic Product Listing, by contrast, focuses on the cosmetic products themselves. The listing submission links the product to the registered facility where it is manufactured or processed.

Together, these two obligations allow the FDA to:

identify which facilities manufacture cosmetic products
identify which cosmetic products are marketed in the United States
link products to specific manufacturing facilities

This regulatory structure strengthens the FDA’s ability to oversee the cosmetic industry and to respond quickly when safety concerns arise.

Deadlines and Timing for FDA Cosmetic Product Listing

MoCRA introduced specific timelines for submitting FDA Cosmetic Product Listings.

For cosmetic products already marketed in the United States when MoCRA entered into force, the Responsible Person must submit the product listing within the regulatory deadline established by the FDA after the law’s implementation.

For new cosmetic products placed on the market after the implementation of MoCRA, the Responsible Person must submit the FDA Cosmetic Product Listing within a defined timeframe after the product is first marketed.

MoCRA also requires Responsible Persons to update the product listing information when certain changes occur. For example, if the ingredient composition of a cosmetic product changes, the listing information must be updated accordingly.

These update requirements ensure that the FDA maintains an accurate and current database of cosmetic products distributed in the United States.

FDA Registration Requirements for Foreign Cosmetic Companies

Foreign cosmetic manufacturers and brand owners that wish to sell cosmetic products in the United States must also comply with FDA Cosmetic Product Listing requirements.

If a cosmetic product manufactured outside the United States is placed on the U.S. market, a Responsible Person located in the United States must be designated for the product. This entity becomes responsible for meeting MoCRA compliance obligations, including submitting the FDA Cosmetic Product Listing.

In addition, foreign cosmetic manufacturing facilities that produce products for the U.S. market must comply with FDA Cosmetic Facility Registration requirements. Under MoCRA, foreign cosmetic facilities must designate a MoCRA US Agent. The MoCRA US Agent serves as the official contact point between the FDA and the foreign facility.

The MoCRA US Agent may assist with regulatory communication, FDA correspondence, and administrative aspects related to facility registration and regulatory oversight.

Consequences of Non Compliance with FDA Cosmetic Product Listing

Failure to comply with FDA Cosmetic Product Listing requirements can create regulatory risks for companies marketing cosmetic products in the United States.

If a cosmetic product is not properly listed as required under MoCRA, the product may be considered misbranded under the Federal Food, Drug, and Cosmetic Act.

Non-compliance may expose companies to regulatory actions such as:

FDA inspections or regulatory inquiries
product enforcement actions
requests for corrective measures
increased regulatory scrutiny

In addition, incomplete or inaccurate regulatory submissions may complicate FDA oversight activities and could delay responses to safety-related concerns.

Ensuring that cosmetic products are properly listed with the FDA is therefore an essential element of MoCRA compliance.

Practical Steps for Completing FDA Cosmetic Product Listing

Companies typically follow a structured regulatory process when preparing FDA Cosmetic Product Listings.

The process generally begins with collecting all necessary product information, including product identification details, ingredient composition, and Responsible Person information.

Companies must also verify whether the manufacturing facility associated with the product has completed FDA Cosmetic Facility Registration, since the facility registration number may be required for the product listing submission.

The Responsible Person then prepares the product listing information and submits it through the FDA’s designated electronic submission system for cosmetic registrations and listings.

After submission, companies should maintain internal regulatory records documenting the product listing information and ensure that any required updates are submitted when product information changes.

Maintaining accurate regulatory records is an important component of ongoing MoCRA compliance.

How Regulatory Experts Can Help with FDA Cosmetic Product Listing

Navigating the regulatory requirements introduced by MoCRA can be complex, particularly for companies unfamiliar with the U.S. cosmetic regulatory framework.

Cosmetic regulatory specialists can assist companies with multiple aspects of FDA Cosmetic Product Listing, including:

reviewing cosmetic product portfolios for MoCRA compliance
identifying the Responsible Person for each cosmetic product
preparing regulatory information required for product listings
ensuring consistency between product labeling and listing data
supporting FDA Cosmetic Facility Registration processes
assisting foreign companies with MoCRA US Agent requirements

Regulatory experts can also help companies implement internal compliance procedures that ensure product listings remain accurate and up to date over time.

Conclusion

FDA Cosmetic Product Listing is a key regulatory requirement introduced by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) to strengthen oversight of cosmetic products marketed in the United States.

Under this framework, the Responsible Person for each cosmetic product must submit product information to the FDA, including product identification details, ingredient information, and facility references.

FDA Cosmetic Product Listing operates alongside FDA Cosmetic Facility Registration, forming a core part of the new regulatory structure governing cosmetic products in the United States.

For cosmetic manufacturers, brand owners, and importers, understanding and complying with FDA Cosmetic Product Listing obligations is essential to ensuring lawful market access and maintaining regulatory compliance under U.S. cosmetic law.

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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