US FDA Cosmetic Regulation: MoCRA
Enacted on December 29, 2022, the Modernization of the Cosmetics Regulation Act of 2022 (MoCRA) is the first major overhaul of the Federal Food, Drug and Cosmetic Act for cosmetics regulation since its passage in 1938, modernizing the country’s cosmetic regulatory framework to meet current needs.
REACH24H specializes in cosmetic regulatory compliance, offering comprehensive support to ensure your business aligns with US MoCRA requirements.
US Cosmetic Compliance Guide
US FDA Cosmetic Facility Registration
Under US MOCRA, any facility that manufactures or processes cosmetics for the U.S. market—whether domestic or foreign—must register with the FDA, including contract manufacturers.
US FDA Cosmetic Product Listing
The manufacturer, packer, or distributor of a cosmetic product—whose name appears on the label—is required to list every marketed cosmetic product, including its ingredients, with the FDA.
US FDA Cosmetic Labeling Requirements
US MoCRA extends the requirements, requesting cosmetic responsible persons to provide additional labeling details.
Responsible Person & US Agent
Every cosmetic product introduced to the US market must have a designated a Responsible Person, who can be the manufacturer, packager, or distributor listed on the product label.
News & Insights
Resources
Guidance on Registration and Listing of Cosmetic Product Facilities and Products
In force ｜ Release Date: 2024-12-11
User's Guide to FDA Direct (Cosmetics Direct)
In force ｜ Release Date: 2024-12-11
Structured Product Labeling (SPL) Implementation Guide with Validation Procedures
In force ｜ Release Date: 2024-12-11
Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing
In force ｜ Release Date: 2024-12-11
California State: Updates to 2020 Toxic-Free Cosmetics Act
In force ｜ Release Date: 2024-12-11
California State: Listing Nail Products Containing Toluene as a Priority Product
In force ｜ Release Date: 2024-12-11
FAQ
For contract manufacturing cases, who should register the facility?
The commissioning party/brand owner can register the facility. Even if the contracted enterprise manufactures its own products or produces for other commissioning parties at the same time, repeated registration is not required.
Do factories engaged in the production and processing of cosmetic raw materials need to register?
At this stage, the FDA requires that factories involved in the production and processing related to the final cosmetic formula (including cases where the final formula consists of only one raw material) must register. Regarding product listing, the FDA expects that the responsible party lists only those products that are marketed to end users (such as the general public or professionals).
Do importers need to register the facility or list products?
If an importer meets the definition of a facility or product responsible person and does not fall within the exempted category, then the importer must proceed with the relevant facility registration or product listing. Otherwise, the importer is not required to take such actions.
Do laboratories that conduct testing solely for cosmetic research and development need to register as a facility?
No, they do not. If a laboratory’s tests are solely for R&D or evaluation of cosmetics, rather than for retail purposes, then the laboratory is not required to register as a facility.
Will product listing information be made public?
Do hair dyeing preparations (including hair dyes) need to be listed?
Yes. Unless they qualify for an exemption, hair dyeing preparations, including hair dyes, must be listed.
How is the receiving date determined for registrations and listings submitted via paper forms?
When the FDA receives paper-submitted documents, a receiving date is assigned. This receiving date is the date on which the submission is actually delivered to the designated receiving unit (the address specified on the paper form) during normal business hours.
Do importers need to list products?
If an importer meets the definition of a facility or product responsible person and does not fall within the exemption criteria, the importer is required to submit the relevant product listing. Otherwise, the importer is not required to take such action.
Do laboratories that perform batch release testing for cosmetics need to register as a facility?
Yes, they do. Batch release testing is considered a part of the product’s manufacturing process, so such laboratories are required to register as a facility.
Do free samples or gifts require product listing submission?
Generally, yes, they require submission. While factories providing free cosmetics at trade shows or other events may be exempt from facility registration under section 604(3) of the FD&C Act, the product listing requirement still applies to cosmetics provided free of charge to consumers.