The Modernization of Cosmetics Regulation Act (MoCRA) introduced a major shift in how cosmetic products are regulated in the United States. One of the most impactful changes is the expanded US FDA authority to access records related to cosmetic manufacturing, safety, and distribution.
Under MoCRA, cosmetic companies are no longer expected only to maintain internal documentation—they must also be prepared to provide specific records to the US FDA upon request. This change significantly strengthens regulatory oversight and places greater accountability on manufacturers, brand owners, private labelers, and importers.
XPRO America is a professional US FDA Consultancy that assists cosmetic companies in establishing compliant recordkeeping systems and preparing for US FDA records access under MoCRA.
Why US FDA Records Access Was Expanded Under MoCRA
Before MoCRA, the US FDA had limited authority to review cosmetic company records unless a product was suspected of causing serious harm. MoCRA expanded this authority to allow the US FDA to request and review records more broadly.
The goals of expanded records access include:
- Improving product traceability
- Strengthening safety oversight
- Supporting faster enforcement actions
- Enhancing consumer protection
- Increasing regulatory transparency
Records access ensures that cosmetic companies can demonstrate compliance, not merely claim it.
When US FDA Can Request Cosmetic Records
Under MoCRA, the US FDA may request records when it has a reasonable belief that a cosmetic product or ingredient:
- Is adulterated or misbranded, and
- Presents a threat of serious adverse health consequences or death
In certain circumstances, the US FDA may also request records during inspections or investigations related to compliance verification.
Who Must Provide Records
The obligation to provide records primarily falls on the Responsible Person and, where applicable, the manufacturing or processing facility.
This includes:
- Brand owners
- Manufacturers
- Private labelers
- Distributors whose name appears on the product label
Foreign companies selling cosmetics in the United States must also comply with records access requirements.
Types of Records Subject to US FDA Access
MoCRA authorizes the US FDA to access a wide range of cosmetic-related records, including:
- Product formulation records
- Ingredient specifications
- Safety substantiation documentation
- Adverse event reports
- Manufacturing and processing records
- Quality control and testing data
- Distribution records
These records must be accurate, complete, and readily retrievable.
Safety Substantiation Records
Cosmetic companies must maintain adequate safety substantiation demonstrating that each product is safe for its intended use.
Safety substantiation records may include:
- Toxicological risk assessments
- Ingredient safety evaluations
- Product testing results
- Scientific literature reviews
These documents are among the most commonly requested records.
Adverse Event Records
Companies must maintain records of all adverse events, including:
- Serious adverse events
- Non-serious adverse events
- Follow-up investigations
- Correspondence
Records must be retained for six years and be accessible for US FDA review.
Manufacturing and GMP Records
MoCRA supports US FDA authority to review records related to manufacturing conditions and quality systems, such as:
- Batch production records
- Cleaning and sanitation logs
- Equipment maintenance logs
- Supplier qualification records
- Training records
These records help verify compliance with good manufacturing practices.
Distribution and Traceability Records
US FDA may request records showing:
- Where products were distributed
- Lot or batch identification
- Quantity released
- Recall-related traceability
Strong traceability systems support rapid response in recall situations.
Format and Accessibility of Records
Records must be:
- Legible
- Organized
- Maintained in English or readily translatable
- Accessible within a reasonable timeframe
Electronic records are acceptable if properly controlled and secure.
Consequences of Failing to Provide Records
Failure to provide requested records may result in:
- US FDA enforcement actions
- Warning letters
- Mandatory recalls
- Import alerts
- Product seizure
Inability to produce records may also be interpreted as evidence of non-compliance.
Best Practices for MoCRA Recordkeeping Compliance
- Establish written recordkeeping SOPs
- Maintain centralized document repositories
- Assign record ownership responsibilities
- Conduct periodic internal audits
- Ensure alignment between labels, formulations, and records
- Work with an experienced US FDA Consultancy
XPRO America helps implement these best practices.
How XPRO America Supports US FDA Records Access Compliance
XPRO America operates as a trusted US FDA Consultancy offering:
- Recordkeeping system design
- Safety substantiation documentation
- Adverse event record management
- GMP documentation support
- Compliance audits
- Inspection readiness programs
- Regulatory correspondence handling
For professional support with MoCRA records access compliance, contact support@xproamerica.com.
Final Thoughts
US FDA records access under MoCRA represents a fundamental shift toward stronger cosmetic oversight. Cosmetic companies must move beyond minimal documentation and establish robust, well-organized recordkeeping systems.
With expert guidance from XPRO America, cosmetic brands can confidently meet US FDA records access requirements and demonstrate full regulatory compliance.
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