MoCRA Update: Records Access for Cosmetic Products

United Safety Agents
Feb 3
2 min read

FDA Issues Draft Guidance on

Records Access for Cosmetic Products

On January 22, 2026, the U.S. Food and Drug Administration (FDA) released a new Draft Guidance addressing Records Access, a requirement added under the Modernization of Cosmetics Regulation Act (MoCRA).

Under MoCRA, the FDA has the authority to access certain cosmetic product records when:

A serious adverse event report has been submitted,
The FDA believes a cosmetic product may pose a risk of Serious Adverse Health Consequences or Death (SAHCOD) to humans, or
During an FDA inspection.

The Draft Guidance explains when records may be requested, which records the FDA can and cannot access, how long records must be maintained, how confidentiality is handled, and the consequences of refusing access.

Guidelines Breakdown:

FDA may request records in the following situations:

Adverse Event Reports
- Upon submission of a serious adverse event by the responsible person.
SAHCOD Concerns
- When FDA has a reasonable suspicion that a cosmetic product may be adulterated and present a SAHCOD risk, including situations involving: product recalls, adverse event reports, consumer complaints, inspections or sampling that reveal potentially unsafe conditions, other circumstances indicating a cosmetic product may pose a SAHCOD risk.

FDA may access the following types of records:

Adverse Event Records
- Communications between the responsible person and any individual who provided information related to the adverse event.
- Records documenting the responsible person's assessment of whether the event was serious or non-serious.
- Medical information and materials related to the serious adverse event.
SAHCOD-Related Records
- Manufacturing records
- Raw material receipt records
- Product distribution and inventory records
- Analytical testing results for raw ingredients and finished products
- Recall records
- Customer distribution lists
- Complaint and adverse event records
- Safety substantiation records
Records FDA Cannot Access
- Cosmetic formulas or recipes
- Financial or pricing data
- Personell records
- Research data
- Sales data

FDA requires records maintenance for adverse events to be:

Maintained in paper or electronic format
Original records or true copies must be retained for:
- Six year from date of creation
- Three years for small businesses

FDA is maintains the confidentiality of:

Personal privacy information
Non-public confidential commercial or trade secret information

Non-public information will only be disclosed as permitted by law and in accordance with FDA procedures.

Refusal to allow FDA access to required records is prohibited. Consequences may include:

Civil or criminal enforcement actions by the U.S. government
Refusal of admission of cosmetic products for sale in the United States

What the Guidance Means for the Industry?

This Draft Guidance signals FDA's intent to actively use its expanded records access authority under MoCRA. Cosmetic companies should ensure they have: