Adverse Event Reporting and the 15 Business Day Rule

A customer emails you a photo of a chemical burn after using your body scrub. Do you have to report that to the FDA? Under MoCRA, the answer depends entirely on how serious it is, and getting that judgment call right, quickly, is now part of running a compliant cosmetic business in the US.

What MoCRA actually requires here

MoCRA, the Modernization of Cosmetics Regulation Act passed in 2022, built a formal adverse event recordkeeping and reporting system into US cosmetic law for the first time at this level of detail. Before MoCRA, there wasn't a comparable federal reporting deadline tied specifically to cosmetic adverse events. Now, the responsible person named for a product, the entity whose name appears on the label, has an obligation to keep records of adverse events and to report the serious ones to the FDA within a defined window.

What makes an event "serious"

Not every complaint triggers a report. A customer saying a lotion smelled off or caused mild, temporary redness that faded on its own is the kind of thing you log internally but don't necessarily escalate. A serious adverse event is generally one involving outcomes like death, a life-threatening experience, hospitalization, significant disfigurement, a birth defect, or an event requiring medical or surgical intervention to prevent one of those outcomes.

The judgment call sits with you and your safety team, but it's meant to be a real, honest assessment, not a technicality you can define your way around. If a report describes something that landed someone in an emergency room or caused lasting scarring, treat it as serious and start the clock.

The reporting window

Once a serious adverse event is confirmed, the responsible person has a defined number of business days to submit that report to the FDA, and this is the window most people mean when they refer to the 15 business day rule. That clock starts running once you have enough information to know the event is both adverse and serious, which is why fast, organized intake matters more than people expect. If your only system for catching these reports is a general customer service inbox that nobody checks for two weeks, you've already put yourself in a difficult position before you even realize a report is needed.

How submission works through MedWatch

Reports get submitted through the FDA's MedWatch system, the same general adverse event reporting infrastructure the FDA uses across other regulated product categories, adapted for the cosmetic reporting requirement. Practically, that means:

• Documenting the event with whatever detail the consumer or reporter provided.
• Identifying the specific product, including lot number if available.
• Submitting through the MedWatch reporting channel within the required window.
• Keeping the underlying records, not just the report itself, since MoCRA also imposes recordkeeping duties independent of the reporting threshold.

Building an intake process that doesn't drop the ball

Most small and mid-size cosmetic brands don't have a dedicated safety department, so this often lands on whoever answers customer emails. A few habits make a real difference:

1. Route health complaints separately. A tag or forwarding rule that flags any email mentioning burns, rashes, hospital visits, or allergic reactions so they don't sit in a general queue.
2. Ask specific follow-up questions fast. What happened, when, what product and lot, and whether they sought medical care. You need this to assess seriousness.
3. Have someone designated to make the serious/not-serious call, even if that's just you, so the decision doesn't get delayed by uncertainty about whose job it is.
4. Keep a simple log of every complaint, serious or not, since recordkeeping obligations extend beyond just the events you report.

Where this fits with everything else

Adverse event reporting is a US federal requirement layered on top of facility registration, product listing, the named responsible person, and safety substantiation duties that MoCRA also introduced. Some small businesses are exempt from parts of MoCRA, particularly registration and listing, but adverse event obligations and the underlying safety expectations are worth checking against your specific business size and structure, since the exemption details matter and this is exactly the kind of thing to confirm with FDA guidance or a regulatory professional rather than assume.

Cosmetic Comply focuses on the ingredient and notification side of compliance, not adverse event case management, but a clean, well-documented ingredient file and safety record makes it a lot easier to have a fast, confident answer when someone asks what's actually in the product that a consumer says reacted badly to it.