Resources/Adverse event reporting
MoCRA serious adverse event reporting: what counts, and the 15-day clock
Disclaimer: The information provided in this guide is for educational and regulatory context purposes only and does not constitute formal legal advice. Compliance requirements can vary based on formulation, regional authority updates, and specific product claims. Consult a certified regulatory affairs professional or specialized legal counsel for official filings. See FDA.gov for current text.
MoCRA added a federal adverse-event reporting duty for cosmetics for the first time — voluntary reporting became mandatory. The term is defined at FD&C Act § 604(5); the reporting obligation itself sits at § 605.
What counts as a "serious" adverse event
Not every complaint triggers a report. A serious adverse event is one that results in — or requires medical or surgical intervention to prevent — any of the following:
- Death
- A life-threatening experience
- Inpatient hospitalization
- Persistent or significant disability or incapacity
- A congenital anomaly or birth defect
- An infection
- Significant disfigurement — including serious/persistent rashes, second- or third-degree burns, significant hair loss, or a persistent or significant alteration of appearance under customary conditions of use
A mild, transient reaction that doesn't rise to one of these outcomes isn't a serious adverse event under the statute — but responsible persons must still receive, record, and evaluate every adverse-event report they get, serious or not.
The 15-business-day deadline
The responsible person must submit a report to FDA within 15 business days of receiving a serious adverse event report, including a copy of the product's label as sold. If new medical information about that same event comes in later — within one year of the original report — it must also go to FDA within 15 business days of receipt.
Recordkeeping
All adverse event reports — not just serious ones — must be kept for 6 years, or 3 years for small-business distributors.
Adverse-event exposure often traces back to an ingredient or concentration issue that a compliance check would have flagged before launch. Run a free INCI compliance scan, or sign in to check a full formulation across US, EU, and other markets at once.
Related: MoCRA overview for US brands, FDA facility registration & product listing.