MoCRA
Quick facts
| Category | U.S. cosmetics and personal care regulatory framework |
|---|---|
| Used by | Cosmetics and personal care product manufacturing |
| Also called | MoCRA |
| Related standards | GMP |
| Related processes | Document control, customer feedback management, supplier management, risk assessment |
| Semantic match | MoCRA, Modernization of Cosmetics Regulation Act, cosmetics FDA regulation, cosmetics GMP requirements |
What is MoCRA?
MoCRA represents a substantial expansion of FDA's authority over cosmetics, an area that had previously operated under far lighter regulatory oversight than other FDA-regulated product categories such as drugs, medical devices and food.
Under MoCRA, manufacturers and processors must register their facilities with the FDA and renew that registration periodically, and companies must list each cosmetic product they distribute in the United States with the agency. Previously voluntary practices, such as reporting adverse events and serious adverse events, are now mandatory.
MoCRA also requires cosmetic companies to maintain safety substantiation records, evaluated by qualified experts, and for the first time makes GMP compliance mandatory for cosmetics manufacturers rather than a voluntary best practice. The law additionally establishes FDA authority to order a mandatory recall if a product is deemed harmful to consumers.
Why is MoCRA important?
MoCRA fundamentally changes the compliance landscape for cosmetics companies, many of which previously operated with minimal formal regulatory obligations compared to other FDA-regulated industries.
Mandatory GMP compliance means cosmetics manufacturers must now build the kind of documented, controlled quality systems that pharmaceutical and medical device companies have long been required to maintain, representing a significant operational shift for many smaller cosmetics companies.
The law's mandatory recall authority and adverse event reporting requirements increase the stakes of safety failures, making proactive safety substantiation and quality documentation more important than ever for companies in this space.
How does MoCRA work?
MoCRA's key requirements include:
- Facility registration. Register manufacturing and processing facilities with the FDA, renewing every two years.
- Product listing. List each cosmetic product distributed in the United States with the FDA.
- Adverse event reporting. Report adverse events and serious adverse events to the FDA.
- Safety substantiation. Maintain records substantiating product safety, evaluated by qualified experts.
- GMP compliance. Implement mandatory Good Manufacturing Practice controls.
- Recall response. Comply with FDA's authority to order a mandatory recall when warranted.
MoCRA vs. Prior Cosmetics Regulation
| Comparison | Before MoCRA | Under MoCRA |
|---|---|---|
| GMP compliance | Voluntary | Mandatory |
| Adverse event reporting | Voluntary | Mandatory |
| Facility registration | Not required | Required, renewed every two years |
Real-world examples of MoCRA
A cosmetics manufacturer registers its production facility with the FDA for the first time under MoCRA, establishing a renewal process to keep the registration current every two years.
A personal care product company builds a formal safety substantiation file for a new product line, engaging a qualified expert to evaluate and document the product's safety before market launch.
A cosmetics brand implements GMP-based quality controls for the first time, documenting procedures and training personnel to meet MoCRA's new mandatory manufacturing requirements.
Regulations and standards related to MoCRA
MoCRA was signed into law as part of the Consolidated Appropriations Act 2023, amending the Federal Food, Drug and Cosmetic Act to expand FDA's cosmetics oversight authority, with implementing regulations continuing to develop as FDA issues further guidance.
Because MoCRA introduced mandatory GMP requirements where none previously existed for cosmetics, companies should confirm current FDA guidance on specific GMP expectations as this area of regulation continues to mature.
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How QT9 helps with MoCRA
QT9 QMS MoCRA capabilities
- Manage MoCRA compliance and synchronize documentation with anyone, anywhere.
- Get comprehensive tools to document, monitor and manage GMP processes.
- Automate the collection, analysis and reporting of adverse events to the FDA.
- Simplify facility and product registrations with centralized data and automated reminders.
- Facilitate gathering, evaluation and storage of product safety substantiation data.
- Enable built-in traceability for faster response to potential recalls.
See QT9 Software in Action
Discover how QT9 Software helps manufacturers improve efficiency, strengthen compliance and connect quality management and ERP processes within one integrated platform.
Common mistakes with MoCRA
Common mistakes include underestimating the operational shift required to implement mandatory GMP controls for the first time, particularly for smaller cosmetics companies without prior quality system infrastructure.
Other problems include treating facility registration and product listing as one-time tasks rather than ongoing obligations requiring renewal and updates as products and facilities change.
Frequently asked questions
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