Cosmetic adverse event reporting under MoCRA
MoCRA requires responsible persons to report serious adverse events to FDA within 15 business days. This page explains what qualifies as serious, how to build compliant workflows, and what record-keeping obligations apply.
What qualifies as a serious adverse event
FDA defines serious adverse events for cosmetics. If any of these apply, reporting within 15 business days is required.
Death
Fatal outcomes associated with cosmetic use.
Life-threatening
Events that put the consumer at immediate risk of death.
Hospitalization
Inpatient admission or prolongation of existing hospitalization.
Disability or permanent damage
Substantial disruption of the ability to conduct normal life functions.
Congenital anomaly or birth defect
Birth defects or abnormalities in offspring.
Requires medical intervention
Events necessitating medical or surgical intervention to prevent one of the above outcomes.
15-business-day timeline
A compliant adverse event workflow from intake to record retention. Set this up before an event occurs to meet deadlines.
Intake
Capture and document the adverse event report from consumer, retailer, or other source.
Triage
Assess whether the event qualifies as serious under MoCRA criteria.
Escalation
Route to regulatory team and collect supporting information (medical records, product details).
FDA submission
Submit the report to FDA via the MedWatch portal or required format within 15 business days.
Record retention
Maintain records for at least 6 years, including copies of submissions and supporting data.
Records must be kept for 6 years
MoCRA requires responsible persons to maintain records relating to adverse events for at least 6 years. This includes copies of reports submitted to FDA, supporting information received from reporters, and any documentation of your triage and escalation process. FDA may inspect these records during facility inspections.
Adverse event reporting FAQs
Common questions about MoCRA adverse event obligations.
What adverse events must be reported under MoCRA?
Serious adverse events must be reported: death, life-threatening events, hospitalization, disability or permanent damage, congenital anomaly or birth defect, and events requiring medical intervention to prevent one of these outcomes. Cosmetic companies must also consider significant disfigurement (serious or persistent rashes, burns, or infections).
What is the 15-business-day timeline?
Once a responsible person receives a report of a serious adverse event associated with their cosmetic product, they must report it to FDA within 15 business days. The clock starts when the report is received. This requires a fast intake and triage process, so many companies establish workflows in advance.
What are the penalties for missing adverse event deadlines?
Failure to report serious adverse events within 15 business days can result in FDA enforcement action, including warning letters, mandatory recalls, import detention of cosmetic shipments, and civil penalties. FDA now has expanded authority under MoCRA to enforce cosmetics compliance.
How long must adverse event records be kept?
MoCRA requires responsible persons to maintain records relating to adverse events for at least 6 years. Records must include copies of reports submitted to FDA and supporting information. FDA may inspect these records during facility inspections.
Who is responsible for adverse event reporting?
The Responsible Person — the manufacturer, packer, or distributor whose name appears on the product label — is legally responsible for adverse event reporting. If you receive a report (e.g., from a retailer or consumer), you must pass it to the responsible person promptly so they can meet the 15-business-day deadline.
Ready to set up your adverse event workflow?
Assurentry helps cosmetic companies build compliant MoCRA workflows, including adverse event intake, triage, and record retention.
No credit card required. Setup takes under 10 minutes.