MoCRA Adverse Event Reporting: The 15-Day Rule Explained

By Alok Naik, R.Ph., M.S. Regulatory Affairs — Managing Partner, Axentra Global Pharma Compliance LLC

One of MoCRA's most immediate, fully-enforced obligations is serious adverse event (SAE) reporting. The Responsible Person must report serious adverse events associated with a cosmetic product to FDA within 15 business days. Missing that window is a compliance failure — so every brand selling in the U.S. needs a system in place before an event ever occurs.

What is a serious adverse event under MoCRA?

A serious adverse event is an adverse experience associated with the use of a cosmetic product that results in outcomes such as death, a life-threatening experience, inpatient 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 that requires, based on reasonable medical judgment, a medical or surgical intervention to prevent one of those outcomes.

A routine, minor complaint isn't automatically an SAE — but the determination requires judgment, which is exactly why a defined intake process matters.

Who must report, and when?

The obligation falls on the Responsible Person — the manufacturer, packer, or distributor named on the label (see Responsible Person vs. U.S. Agent). Under Section 605 of the FD&C Act:

• Report within 15 business days of receiving information about a serious adverse event.

• Submit new and material information that you receive within one year of the initial report as a follow-up.

• The report must include a copy of the product label, which is one practical reason your labeling and contact information must be accurate and accessible.

The label connection: required contact information

MoCRA requires that cosmetic product labels include a domestic address, phone number, or electronic contact information through which the Responsible Person can receive adverse event reports. If consumers can't reach you, you can't capture the events you're legally required to report. (See MoCRA cosmetic labeling requirements.)

Recordkeeping

The Responsible Person must maintain records related to adverse events. The general retention period is six years, with a shorter retention period available to certain small businesses. These records must be available to FDA on request — so they need to be organized, not scattered across inboxes.

Build your SAE system before you need it

1. Create an intake channel that matches the contact info on your label (email, phone, web form).

   
   

2. Define triage criteria to distinguish serious from non-serious events using the statutory definition.

   
   

3. Set a 15-business-day clock the moment an event is received, with an owner accountable for the filing.

   
   

4. Template the FDA submission, including attaching the product label.

   
   

5. Log and retain everything for the required period.

   
   

6. Train whoever answers customer messages — front-line staff are usually the first to hear about an event.

Don't wait for an incident to build this. Axentra helps Responsible Persons stand up MoCRA-compliant adverse-event intake, triage, and 15-day reporting workflows. Set up your SAE process.

Full obligation set: MoCRA cosmetics compliance. Source framework: FDA's MoCRA page.

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Frequently asked questions

How quickly must serious adverse events be reported under MoCRA?

The Responsible Person must report a serious adverse event to FDA within 15 business days of receiving the information, and must submit material new information received within one year as a follow-up.

Who is responsible for adverse event reporting?

The Responsible Person — the manufacturer, packer, or distributor whose name appears on the product label — is responsible for serious adverse event reporting under Section 605 of the FD&C Act.

What counts as a serious adverse event for cosmetics?

Outcomes such as death, life-threatening experiences, hospitalization, significant disability, birth defects, infection, or significant disfigurement — including serious rashes, burns, significant hair loss, or persistent alteration of appearance — or events requiring medical or surgical intervention to prevent such outcomes.

How long must adverse event records be kept?

Generally six years, with a shorter retention period available to certain small businesses. Records must be available to FDA upon request.