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FDA: New Guidance on Access to Records for Cosmetics under MoCRA
- Daniel Jiménez
- 11 hours ago
- 3 min read
In January 2026, the Food and Drug Administration (FDA) published draft guidance that provides greater clarity regarding its authority to access and copy records related to cosmetic products marketed in the United States. This document was developed under the Modernization of Cosmetics Regulation Act (MoCRA), the most significant reform of the U.S. cosmetics industry in more than 80 years.
Although this is a preliminary guide open to comments, its content confirms an important regulatory trend: the FDA is strengthening its documentary oversight and inspection capabilities in the cosmetics sector, progressively bringing it closer to regulatory models already consolidated in food and medical devices.
For international manufacturers, brands, and distributors operating in the US market, understanding these new expectations is key to ensuring compliance.
Table of contents
Legal framework: sections 605, 610 and 704 of the FD&C Act
The guide describes how the FDA will exercise its authority under three main provisions:
Section 605 — Adverse Event Records
Section 610 — Risk of serious health consequences (SAHCOD)
Section 704 — Inspections
These provisions significantly expand the agency's ability to request documentation from responsible companies and registered facilities.
Access to adverse event records (Section 605)
The FDA may request access to and a copy of records related to adverse event reports associated with the use of a cosmetic in the United States.
One of the most relevant aspects for the industry is the record retention requirement:
6 years for standard companies
3 years for small businesses
This includes not only the adverse event report, but also:
Internal investigations
Causality assessments
Related communications
Corrective actions implemented
Many international companies still do not have structured cosmetovigilance systems aligned with these expectations, which can pose a risk during an inspection or investigation.
Access to records for serious health risks (Section 610)
The FDA may also request registrations when there is a reasonable belief that a cosmetic product may be adulterated in a way that poses a risk of: Serious Adverse Health Consequences or Death (SAHCOD)
In these cases, the agency may require documentation from both the Responsible Person and the manufacturing facility, after presentation of credentials and written notification.
This point connects directly with other MoCRA requirements such as:
Safety substantiation
Good Manufacturing Practices (GMP)
Traceability systems
Product recall procedures
Strengthening FDA inspections on cosmetics (Section 704)
The guide confirms that the FDA is consolidating its documentary inspection capabilities in the cosmetics sector.
Historically, inspections in cosmetics were limited compared to other regulated industries. However, MoCRA introduces a structural change that requires companies to adopt more robust approaches to quality management and documentation.
Practical implications for international companies
One of the most frequent mistakes we observe in companies that export to the United States is assuming that the European Product Information File (PIF) automatically covers US requirements.
In reality, MoCRA introduces additional expectations, especially in:
Adverse event management
Document retention
Preparation for inspections
Traceability systems in the USA.
Recall procedures
Structured safety substantiation
Regulatory trend: greater supervision and accountability
The publication of this guide confirms a clear evolution of the US regulatory model:
Greater inspection authority
Greater responsibility of the Responsible Person
Stricter documentation requirements
Greater FDA intervention capacity
For international brands, this implies a strategic change: moving from a reactive approach to a preventive approach based on quality systems.
Conclusion
The FDA's new guidance on access to records represents another step in the implementation of MoCRA and confirms that the regulatory environment for cosmetics in the United States is entering a new stage of greater control and oversight.
Companies that anticipate these changes will be better positioned to operate safely in the US market.
At Belab Services we help international brands comply with regulatory requirements in the United States and more than 60 global markets.
