A New Era of Cosmetic Safety Reporting
Before MoCRA, adverse event reporting for cosmetics was entirely voluntary. The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, changed that — introducing mandatory reporting requirements for serious adverse events.
This is one of the most significant operational changes MoCRA imposes on the cosmetics industry.
What Is a Serious Adverse Event?
Under MoCRA, a serious adverse event associated with a cosmetic product is one that results in:
- Death
- A life-threatening experience
- Inpatient hospitalization
- Persistent or significant disability or incapacity
- Congenital anomaly or birth defect
- Significant disfigurement (including serious skin reactions, eye injuries)
- Any other significant adverse health consequences that require medical intervention
Who Must Report?
The Responsible Person — the manufacturer, packer, or distributor whose name appears on the product label — is obligated to submit serious adverse event reports to FDA.
The 15-Business-Day Reporting Window
When the Responsible Person receives a report of a serious adverse event, they must submit it to FDA within 15 business days of receiving the information.
The report must include:
- The product name and any applicable product codes
- The Responsible Person's name and contact information
- Date of the adverse event
- Description of the event and outcome
- Consumer demographics (if known)
One-Year Follow-Up Reporting
If new and material information is received within 1 year of the initial serious adverse event report, the Responsible Person must submit a follow-up report to FDA within 15 business days of receiving that new information.
Recordkeeping Requirements
Responsible Persons must maintain records related to each adverse event — serious or not — for 6 years. For small businesses (under $1M in annual gross sales), the retention period is 3 years.
Records must be available for FDA inspection upon request.
Setting Up Your Adverse Event System
A compliant adverse event system for cosmetics should include:
- Consumer complaint intake — a dedicated channel (phone, email, web form) for consumers to report product reactions
- Triage protocol — criteria for classifying an event as serious vs. non-serious
- 15-business-day tracking — a workflow ensuring reports are reviewed and submitted on time
- FDA submission process — reports are submitted via FDA's MedWatch Safety Reporting Portal
- Recordkeeping system — centralized storage of all adverse event records for the required retention period
- Staff training — front-line staff must know when and how to escalate a consumer complaint
Common Compliance Gaps
- No formal intake channel for adverse event reports
- No written triage criteria to distinguish serious from non-serious events
- Countdown to 15 business days not being tracked
- Records not retained for the required period
- Confusion about who is the "Responsible Person" for private-label products
How United Regulatory Can Help
We design and implement MoCRA-compliant adverse event reporting systems — intake procedures, triage protocols, FDA submission workflows, and staff training. Contact us to get your system in place before your next product launch.