The short answer
Since MoCRA, the responsible person for a cosmetic — the manufacturer, packer or distributor named on the label — must report every serious adverse event linked to the product in the U.S. to FDA within 15 business days of receiving the report, with a copy of the label. Non-serious complaints are not reported, but all adverse event records must be kept for 6 years (3 years for qualifying small businesses).
This applies to small businesses too: the small business exemption covers registration, listing and GMP, not adverse event reporting.
What is a “serious” adverse event?
An adverse event is any health-related event associated with using a cosmetic that is adverse. It is serious if it results in:
| Outcome | Cosmetic examples |
|---|---|
| Death or a life-threatening experience | Severe allergic reaction (anaphylaxis) |
| Inpatient hospitalization | Admission after a reaction to a hair relaxer |
| Persistent or significant disability or incapacity | Lasting eye damage |
| Congenital anomaly or birth defect | — |
| An infection | Eye infection from a contaminated mascara |
| Significant disfigurement | Serious and persistent rashes, second- or third-degree burns, significant hair loss, persistent or significant change in appearance not intended by the product |
| Requires medical or surgical intervention to prevent one of the above | Treatment to prevent permanent scarring |
How to report
- 1Start the 15-business-day clockThe clock starts when the responsible person receives the report — from a consumer, a salon, a retailer, Amazon, social media or your U.S. contact on the label.
- 2Use MedWatch Form FDA 3500AFDA’s mandatory reporting form. Send it by email to CosmeticAERS@fda.hhs.gov or by mail, with a copy of the product label.
- 3Send follow-up informationNew and material medical information received within 1 year of the first report must also be sent within 15 business days.
- 4Keep recordsRecords of all adverse events — serious and non-serious — for 6 years, or 3 years for qualifying small businesses.
Who reports when there are several companies?
- The responsible person is the company whose name appears on the label.
- That can be a manufacturer, a packer or a distributor. If a distributor’s name is on the label, the distributor is the responsible person — agree in writing how complaints reach it.
- The U.S. contact on the label (address, phone or website) is where consumers send reports — MoCRA requires it on every cosmetic label.
Example: a skincare brand from Canada
A Canadian brand sells a chemical exfoliant online in the U.S. A customer emails a photo of a second-degree burn treated at an urgent care clinic. That is a serious adverse event. The brand files Form 3500A with FDA by email within 15 business days, attaches the label, and sends the clinic’s follow-up notes when they arrive six weeks later. It also logs a separate complaint about mild stinging — not reportable — and keeps both records for 6 years.
Cosmetic facility registration with U.S. Agent from $300 (1 year) or $450 (2 years). Product listing $150 per product. Cosmetics label review $250.
Frequently asked questions
How long do I have to report a serious cosmetic adverse event?
15 business days from when the responsible person receives the report.
Which form is used?
MedWatch Form FDA 3500A, sent to CosmeticAERS@fda.hhs.gov or by mail, with a copy of the label.
Do I need to report mild skin irritation?
Not if it is not serious. But you must keep a record of it.
How long must I keep adverse event records?
6 years, or 3 years for small businesses that qualify under MoCRA.
Are small businesses exempt from adverse event reporting?
No. The small business exemption covers registration, listing and GMP only.
Sources
- FDA — MoCRA serious adverse event reporting for cosmetic products
- 21 U.S.C. 364 — MoCRA definitions (serious adverse event, responsible person)
- dicentra — MoCRA in 2026 (record retention, adverse event reporting)
- Loeb & Loeb — MoCRA increases FDA oversight of the cosmetics industry
Requirements checked on November 11, 2026. This article is general information, not legal advice.