Quick Answer
Under MoCRA (Modernization of Cosmetics Regulation Act of 2022), responsible persons must report serious adverse events associated with their cosmetic products to FDA within 15 business days. They must also maintain records of all adverse events (serious and non-serious) for a minimum of 6 years. This is the first-ever mandatory adverse event reporting requirement for cosmetics in the US.
Regulatory Authority: FD&C Act Section 605 (as amended by MoCRA) — Adverse Event Reporting for Cosmetics
What Is MoCRA Adverse Event Reporting?
Foreign Facility
Raw Data InputTranslation Layer
Validation ActiveFDA FURLS
Live SyncCompliance Vault
ImmutablePrior to MoCRA, there was no federal requirement for cosmetic companies to report adverse events to FDA. MoCRA changed this by establishing mandatory serious adverse event reporting for all cosmetic products marketed in the United States, effective December 29, 2023.
The reporting obligation falls on the "responsible person" — defined as the manufacturer, packer, or distributor whose name appears on the cosmetic product label under the Fair Packaging and Labeling Act. This is the entity that consumers contact with complaints and the entity FDA holds accountable for reporting.
Who Must Report
- Responsible person: The company named on the product label — must report all serious AEs to FDA
- Contract manufacturers: Must report serious AEs to the responsible person within 15 business days of receiving the information
- Foreign manufacturers: If they are the responsible person on US-market products, they have the same reporting obligations
Defining a Serious Adverse Event Under MoCRA
Foreign Supplier
HACCP Plan Required
Assurentry FSVP Engine
FDA Systems
Audit Ready Records
MoCRA defines a "serious adverse event" as an adverse event that results in any of the following outcomes:
- Death
- Life-threatening experience: Immediate risk of dying at the time of the event
- Inpatient hospitalization: Admission to a hospital (not ER visits or outpatient treatment)
- Persistent or significant disability or incapacity: Substantial disruption of normal life functions
- Congenital anomaly or birth defect
- Requires medical or surgical intervention: To prevent one of the above outcomes
What Counts as an "Adverse Event"?
An adverse event is any health-related event associated with the use of a cosmetic product. This includes:
- Skin reactions (rash, irritation, chemical burns, allergic contact dermatitis)
- Eye injuries from eye area products
- Hair loss or scalp injury from hair products
- Respiratory reactions from aerosolized products
- Infections attributed to contaminated products
Note: The event must be associated with the use of the product. Misuse, tampering, or product quality complaints that do not involve a health-related event do not qualify as adverse events under MoCRA.
15-Day Reporting Requirements
When a responsible person receives information about a serious adverse event, they must submit a report to FDA within 15 business days. The clock starts when the responsible person (or their agent) first becomes aware of the event.
Report Content
Product Information
Name of the cosmetic product as it appears on the label, along with any identifying information (lot number, UPC code, etc.).
Adverse Event Description
Detailed description of the adverse event, including the nature and severity of the health-related outcome.
Reporter Information
Contact information for the individual who reported the event to the responsible person.
Responsible Person Information
Name, address, and contact information of the responsible person submitting the report.
Follow-Up Reports
If new medical information becomes available within one year of the initial report, the responsible person must submit a follow-up report to FDA within 15 business days of receiving the new information. This ensures FDA has the most complete picture of the adverse event.
Record Retention Obligations
FDA Observation
"Procedures for verifying supplier controls were not adequately established."
CAPA Deployed
Assurentry auto-generates a 15-day response plan with acceptable corrective actions.
MoCRA requires responsible persons to maintain records related to adverse events for a minimum of 6 years. This applies to both serious and non-serious adverse events. Records must be made available to FDA upon request.
What Records to Retain
- All adverse event reports: Initial consumer/HCP reports, internal assessments, and all correspondence
- Serious AE submissions: Copies of all reports submitted to FDA, including follow-up reports
- Investigation records: Internal investigation notes, root cause analysis, and any corrective actions taken
- Product distribution data: Records sufficient to identify the product batch/lot involved
- Contact records: Documentation of follow-up communications with reporters
Electronic vs. Paper Records
MoCRA does not specify a format for record keeping. Records may be maintained electronically or on paper, but must be readily retrievable and legible. Electronic systems should have appropriate access controls and backup procedures.
Building an AE Intake and Triage Process
Automated Extraction
Our systems parse complex FDA documents into actionable data instantly.
A robust adverse event intake process is essential for meeting MoCRA's tight reporting deadlines. Key elements include:
Capture All Contacts
Every consumer contact channel (phone, email, social media, website forms, retailer reports) must feed into your AE intake system. Train all customer-facing staff to recognize potential adverse events.
Triage for Seriousness
Evaluate each report against MoCRA's serious AE criteria within 24-48 hours of receipt. Use a standardized triage checklist to ensure consistency.
Document Thoroughly
Record the product involved, symptoms described, onset timeline, medical treatment sought, and reporter contact information. Request photos when available.
Submit to FDA (If Serious)
Submit serious AE reports through the FDA CFSAN Adverse Event Reporting System (CAERS) within 15 business days.
Follow Up and Monitor
Contact the reporter for additional information. Monitor for additional reports involving the same product or lot that may indicate a broader safety signal.
Common Mistakes and How to Avoid Them
Based on early MoCRA enforcement trends, here are the most common adverse event reporting mistakes cosmetic companies make:
Missing the 15-business-day deadline
Fix: Implement automated triage alerts and tracking. The clock starts when ANY employee or agent first learns of the event — not when regulatory affairs reviews it.
Failing to capture AEs from social media
Fix: Monitor brand mentions on social media for potential adverse event reports. Social media posts describing health reactions count as AE reports.
Not reporting contract manufacturer AEs
Fix: Establish clear agreements requiring contract manufacturers to forward AE reports within 15 business days.
Confusing product complaints with adverse events
Fix: A product complaint (e.g., 'the color is wrong') is not an AE. An AE requires a health-related event. But err on the side of capturing more — you can triage later.
Inadequate record retention
Fix: Set up a 6-year retention policy from day one. Many companies default to shorter retention periods that don't meet MoCRA requirements.
For MoCRA facility registration and product listing, see our Cosmetic Registration Guide. For safety substantiation requirements, visit our MoCRA Safety Substantiation Guide.
Stop reading. Start executing.
Assurentry acts as a technical translation layer. You provide basic business info, and we automatically generate and file the exact electronic submissions required by the FDA.
Automate compliance100% FDA Acceptance Guaranteed