In December 2022, the United States enacted a landmark law that fundamentally reshaped cosmetic regulation—the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This legislation represents the most significant update to cosmetic law in over 80 years and dramatically expanded US FDA authority over cosmetic products marketed in the United States.
Before MoCRA, cosmetic regulation was primarily voluntary, relying on the responsibility of manufacturers to ensure product safety and truthful labeling. With MoCRA, compliance became legally enforceable, creating new obligations for cosmetic companies, including facility registration, product listing, safety substantiation, adverse event reporting, and good manufacturing practice expectations.
XPRO America is a professional US FDA Consultancy that helps cosmetic manufacturers, brand owners, and importers understand and meet MoCRA requirements with accuracy and confidence.
What Is the Modernization of Cosmetics Regulation Act (MoCRA)?
The Modernization of Cosmetics Regulation Act of 2022 is a federal statute that amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to strengthen regulatory oversight of cosmetics. MoCRA codified requirements that were previously voluntary and introduced several new legal obligations with which cosmetic companies must comply.
Key highlights of MoCRA requirements include:
- Mandatory facility registration
- Cosmetic product listing
- Safety substantiation
- Adverse event reporting
- Good manufacturing practice expectations
- Recordkeeping standards
- Mandatory recalls under specific conditions
These requirements apply to all cosmetic products sold in the United States, including those manufactured abroad.
Why MoCRA Matters for Cosmetic Compliance
Prior to MoCRA, the US FDA had limited authority over cosmetics. While cosmetic products had to be safe and properly labeled, the US FDA did not require manufacturers to report safety data or register products and facilities.
MoCRA changed that paradigm. Today, cosmetic companies must proactively demonstrate compliance with a comprehensive regulatory framework enforced by the US FDA.
This shift impacts nearly every aspect of cosmetic operations, from manufacturing to labeling, safety documentation, and market surveillance.
Facility Registration Under MoCRA
One of MoCRA’s foundational requirements is the mandatory registration of cosmetic manufacturing and processing facilities with the US FDA.
Who must register?
- Domestic manufacturers
- Foreign manufacturers exporting cosmetics to the US
Key registration features:
- Initial submission to US FDA
- Renewals every two years
- Updates required for changes in ownership, address, or operations
- Foreign facilities must designate a US Agent
Failure to register can result in enforcement actions, including import detentions and refusal of entry.
XPRO America assists companies with complete facility registration and US Agent designation as part of its US FDA Consultancy offerings.
Cosmetic Product Listing
MoCRA requires that cosmetic products marketed in the United States be listed with the US FDA.
Product listing includes:
- Product name and category
- Ingredient list
- Facility registration reference
- Responsible person details
Cosmetic product listings must be updated annually and when product formulations change.
Accurate listing enhances traceability and allows the US FDA to monitor products effectively.
XPRO America prepares and manages product listing submissions to ensure regulatory accuracy.
Safety Substantiation Requirements
MoCRA mandates that cosmetic companies maintain adequate safety substantiation for every product they market.
This means having scientific evidence demonstrating that a cosmetic product is safe for its intended use.
Safety substantiation may include:
- Toxicological risk assessments
- Ingredient safety profiles
- Product performance data
- Scientific literature reviews
Companies must have documentation ready for US FDA inspection if requested.
XPRO America helps brands develop safety documentation that aligns with MoCRA expectations.
Adverse Event Reporting Obligations
Under MoCRA, companies must report serious adverse events to the US FDA within 15 business days.
What qualifies as a serious adverse event?
- Hospitalization
- Life-threatening reaction
- Permanent impairment
- Birth defect
- Death
Companies must keep adverse event records for six years.
XPRO America establishes reporting procedures and adverse event tracking systems to meet MoCRA requirements.
Good Manufacturing Practice (GMP) Expectations
Although MoCRA does not yet mandate detailed cosmetic GMP regulations, it directs the US FDA to issue guidance and, eventually, enforceable GMPs.
In the meantime, MoCRA requires:
- Sanitary manufacturing conditions
- Appropriate quality systems for cosmetics
- Adequate recordkeeping
- Controls to prevent contamination and ensure safety
Good manufacturing practices help ensure product consistency, safety, and regulatory compliance.
XPRO America assists with developing and implementing compliant quality systems.
Labeling and Claims Under MoCRA
Cosmetic labels must continue to comply with existing law, including:
- Fair Packaging and Labeling Act (FPLA) requirements
- Ingredient declaration using INCI names
- Truthful and non-misleading claims
MoCRA reinforces the importance of accurate labeling and adds expectations for product listing and documentation.
XPRO America conducts detailed label reviews to ensure cosmetic labeling meets MoCRA and other federal compliance standards.
Recordkeeping Requirements
MoCRA requires cosmetic companies to maintain:
- Product formulation records
- Safety substantiation documentation
- Adverse event records
- Listing and registration records
- Manufacturing and quality control records
These records must be accessible for US FDA inspection when necessary.
XPRO America helps brands establish organized and compliant recordkeeping systems.
Import Compliance Under MoCRA
Cosmetics manufactured abroad must meet the same MoCRA requirements as domestic products.
Foreign facilities must:
- Register with the US FDA
- Appoint a US Agent
- List products
- Maintain safety documentation
Non-compliant products may be detained or refused entry at US ports.
XPRO America provides import compliance support to foreign manufacturers and exporters.
US FDA Enforcement Under MoCRA
MoCRA significantly enhanced US FDA enforcement authority, including:
- Warning letters
- Mandatory recalls under certain conditions
- Product seizures
- Import alerts
- Injunctions
Companies that fail to comply expose themselves to legal action, financial loss, and brand damage.
Proactive compliance with MoCRA helps mitigate these risks.
Strategic Advantages of MoCRA Compliance
By complying with MoCRA, cosmetic companies gain:
- Increased transparency and traceability
- Better safety documentation
- Enhanced consumer trust
- Stronger retailer confidence
- Reduced regulatory risk
- Improved market competitiveness
Compliance becomes a business advantage, not just a legal requirement.
How XPRO America Can Help
XPRO America operates as a dedicated US FDA Consultancy offering MoCRA compliance services such as:
- Facility registration
- Cosmetic product listing
- Safety substantiation support
- Labeling and claim review
- Adverse event reporting systems
- Import compliance guidance
- Recordkeeping systems
- Quality and GMP consulting
For expert regulatory assistance, contact XPRO America at support@xproamerica.com.
Conclusion
The Modernization of Cosmetics Regulation Act of 2022 ushered in a new era of cosmetic regulation in the United States. MoCRA’s expanded requirements and strengthened US FDA authority make compliance mandatory and enforceable.
With professional guidance from XPRO America, cosmetic brands can navigate these regulatory complexities and ensure their products meet all legal expectations while focusing on growth and innovation.
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