What Is MoCRA Cosmetic Facility Registration?
MoCRA Cosmetic Facility Registration
Definition
FDA facility registration required for covered cosmetic product manufacturers and processors under the Modernization of Cosmetics Regulation Act.
Overview
MoCRA Cosmetic Facility Registration FDA facility registration required for covered cosmetic product manufacturers and processors under the Modernization of Cosmetics Regulation Act.
MoCRA introduced a mandatory federal registration regime for facilities that manufacture or process covered cosmetic products for the U.S. market. The registration replaces the prior voluntary programs that many companies used and creates a centralized record the Food and Drug Administration (FDA) can use for inspections, recalls, and safety oversight.
What The Registration Covers
The registration program captures facility-level information the FDA needs to identify where cosmetics are made or processed and how to contact responsible parties. Typical elements include ownership and contact details, facility address, and the types of operations performed (manufacturing, processing, packing, holding). The FDA may also require product listing and additional safety-related information under MoCRA.
Who Must Register
Facilities that manufacture or process cosmetic products covered by MoCRA for distribution in the United States are subject to registration. This generally includes domestic manufacturers, contract manufacturers, co-packers, and certain processors. Importers do not register the foreign manufacturing site — the foreign facility itself must register if it meets the covered activity definition.
How It Differs From The Old Voluntary Program
- Mandatory vs Voluntary: MoCRA registration is compulsory for covered facilities, replacing the long-standing Voluntary Cosmetic Registration Program (VCRP).
- Regulatory Use: The FDA will use the registration for enforcement priorities, inspections, and product safety responses rather than the VCRP's limited market-data role.
- Data Expectations: MoCRA can require more up-to-date contact and operational data than the VCRP typically captured.
Practical Compliance Steps
- Assess Coverage: Determine whether your facility manufactures, processes, packs, or holds covered cosmetic products for the U.S. market.
- Gather Records: Compile facility addresses, legal owner information, operational descriptions, and any delegated agent details.
- Use FDA Channels: Submit registration through FDA-designated electronic systems when available and follow instructions on required updates and renewals.
Why Managers Should Care
Facility registration affects market access: failure to register a covered facility can expose a business to enforcement action and complicate import and distribution. Accurate registration speeds FDA communications during product-safety incidents and reduces friction during inspections or recalls.
In short, the MoCRA Cosmetic Facility Registration establishes a mandatory federal register of cosmetic manufacturers and processors that supports FDA oversight, safety response, and regulatory enforcement for cosmetic products sold in the United States.
Sources And Additional Reading (3)
- Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
“Modernization of Cosmetics Regulation Act of 2022 (MoCRA).” U.S. Food and Drug Administration, https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra.
- Cosmetics
“Cosmetics.” U.S. Food and Drug Administration, https://www.fda.gov/cosmetics.
- Reporting Serious Adverse Events for Cosmetic Products
“Reporting Serious Adverse Events for Cosmetic Products.” U.S. Food and Drug Administration, https://www.fda.gov/cosmetics/cosmetic-safety/reporting-serious-adverse-events-cosmetics.
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