What Is FDA Adverse Event Management Under MoCRA?
MoCRA made cosmetic adverse-event handling a legal duty. Learn what must be recorded, what must reach the FDA within 15 business days, and who is responsible.
Jul 30, 2026Read more →
Cosmetics — MoCRA compliance
FDA Adverse Event Management for Cosmetic Brands
Under the Modernization of Cosmetics Regulation Act (MoCRA), handling adverse events is not optional — it is a legal duty of the Responsible Person for every cosmetic product sold in the United States. Most foreign brands have no US presence to receive reports, no process to assess them, and no way to file with the FDA on time. We become that function for you.
Ongoing MoCRA obligation
Your program stays ready
- Every report logged and assessed
- Serious events filed within 15 business days
- Six-year audit-ready records
- A managed US intake option
The legal duty
What MoCRA actually requires
Every Responsible Person must maintain records for health-related adverse events associated with its cosmetic products; the standard retention period is six years, while qualifying small businesses have a three-year statutory minimum. Any serious adverse event must be reported to the FDA within 15 business days, and new medical or other information related to that report must be submitted for one year afterward. The product label must also carry a channel through which reports can be received: a domestic address, domestic telephone number, or electronic contact information. Miss an applicable requirement and the product or Responsible Person can face FDA enforcement.
Keep the record
Log every health-related adverse event and preserve a complete, inspection-ready file. Our managed program retains records for six years for every client.
Assess and report
Determine whether each report meets the statutory definition of serious and file qualifying reports within 15 business days.
Maintain an intake channel
Place a compliant contact channel on the label and make sure every report reaching it enters a controlled process immediately.
Managed service
What we handle for you
We act as your adverse-event function in the United States: intake and logging of every report received; assessment of whether an event meets the FDA's definition of serious; preparation and filing of the FDA MedWatch Form 3500A within the 15-business-day window when a report is serious; any follow-up filings required over the following year; six-year record retention; and a monthly written summary so you always know your status. You get a compliant, audit-ready adverse-event program without building one yourself.
- Report intake and controlled case logging
- Seriousness assessment against FDA criteria
- MedWatch Form 3500A preparation and submission
- One-year follow-up monitoring and filings
- Six-year record retention
- Monthly written status summary
Choose your setup
Two ways we can manage it
Option 1 — We are your listed contact
Our US details appear on your product label as the adverse-event contact, and we operate the intake channel directly. Reports come to us; we log, assess, and file. Best for brands that have no US presence and want the whole function outside their business.
Option 2 — You stay on the label, we do the work
Your own contact remains on the label. You forward each report you receive to us within 24 hours, and we take it from there — assessment, filing, records, reporting. Best for brands or established Responsible Persons that want to keep their labelled contact but hand off the regulatory work.
Both options include the full scope above and cover a set number of reports and serious-event filings per year, with clear terms for higher volumes. We'll recommend the right option for your setup on a short call.
The cost of delay
What happens if adverse events go unreported
This is where foreign brands get hurt. Failing to keep required records or report a serious event on time is a prohibited act, and a label without the required adverse-event contact channel can make a cosmetic misbranded. FDA may refuse an imported product that appears violative, and repeated or unresolved problems can lead to detention, an import alert, or inspection findings. MoCRA also permits FDA to suspend a facility registration when the statute's serious-health-risk conditions are met, stopping US distribution from that facility, and to order a mandatory recall when a product presents the required serious risk and the responsible person does not voluntarily recall it. A single unhandled complaint can expose a missing system and put an entire US business on hold. The filing itself is small; the cost of missing it is not.
FAQ
Common questions
Is adverse event reporting really mandatory?
Yes. Under MoCRA, reporting serious adverse events is a legal obligation of the Responsible Person for every cosmetic sold in the US, regardless of company size or where the product is made. Recordkeeping and label-contact obligations also apply, subject to the statute's limited small-business provisions.
What counts as a "serious" adverse event?
Broadly: death, a life-threatening experience, hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, or significant disfigurement — including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance — or an event requiring medical or surgical intervention to prevent one of these outcomes.
How fast must a serious event be reported?
Within 15 business days after the Responsible Person receives the report. Industry submissions use FDA MedWatch Form 3500A, and new medical or other information related to the initial report must also be submitted within 15 business days of receipt for one year.
Do I need a US contact on my label?
The label must provide a domestic address, domestic telephone number, or electronic contact information through which the Responsible Person can receive adverse-event reports. We can provide and manage the US contact channel under Option 1.
We've never had an adverse event — do we still need this?
Yes. The obligation to maintain a compliant intake, assessment, recordkeeping, and reporting process exists whether or not an event has occurred. The point is to be ready and compliant before one does.
Does this cover our whole product range?
Yes. The program can cover your full cosmetic product range; larger catalogues and higher report volumes are simply scoped accordingly.
MoCRA guidance
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Make your US adverse-event obligations someone else's job.
Put a documented intake, assessment, filing, follow-up, and recordkeeping program in place before the first report arrives.