Cosmetic Adverse Event Reporting Under MoCRA

A New Regulatory Framework for Cosmetics

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) introduced the most significant expansion of FDA authority over cosmetics since the Federal Food, Drug, and Cosmetic Act of 1938. Among the most operationally significant requirements for cosmetics companies is mandatory serious adverse event reporting to FDA, a requirement that previously applied to drugs, medical devices, and dietary supplements but had no equivalent in the cosmetics space.

For companies navigating these requirements, the core question is how to build systems that consistently capture, evaluate, and report adverse events within the timelines FDA requires. This guide covers what MoCRA requires for adverse event reporting, who is responsible for compliance, and what effective programs typically include.

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Who Is Responsible: The "Responsible Person" Definition

MoCRA uses the term "Responsible Person" to designate who bears reporting obligations. According to the FDA, the Responsible Person is "the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product" in accordance with applicable labeling law.

In practical terms, this means the entity whose name is on the product label carries the compliance obligation for adverse event reporting, regardless of where the product was manufactured. For products sourced from contract manufacturers or produced internationally, the U.S. company whose name appears on the label should evaluate whether they meet the Responsible Person definition and what that means for their reporting obligations.

Responsible Persons also have other MoCRA obligations beyond adverse event reporting, including facility registration, product listing, safety substantiation, and labeling requirements. Each of these areas has its own requirements and timelines under FDA guidance.

What MoCRA Defines as a Serious Adverse Event

MoCRA distinguishes between adverse events and serious adverse events. An adverse event is any health-related event associated with cosmetic product use that is adverse. The serious adverse event definition, which triggers reporting obligations, is more specific. Visit our detailed blog on adverse event management services for more information on comprehensive FDA solutions for regulatory compliance.

According to FDA's December 2023 constituent update, a serious adverse event under MoCRA is one that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, or significant disfigurement. The disfigurement category includes serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance other than as intended. An event is also considered serious if it requires, based on reasonable medical judgment, a medical or surgical intervention to prevent one of these outcomes.

Companies building adverse event intake processes should work with medical and regulatory professionals to develop consistent internal criteria for evaluating whether specific events meet the serious adverse event threshold. Because the determination often requires clinical judgment, having qualified reviewers involved in the triage process is an important part of a well-functioning program.

The 15-Business-Day Reporting Requirement

MoCRA requires the Responsible Person to report serious adverse events to FDA within 15 business days after receiving the report. The clock starts when the company receives information about the event, not when the event occurred.

This distinction matters operationally. Adverse event information can come through many channels: consumer calls to a customer service line, emails, social media messages, retailer or distributor reports, healthcare provider notifications, or litigation-related disclosures. Building intake processes that capture and timestamp adverse event information consistently across all those channels helps ensure the 15-business-day window is tracked accurately from the moment of receipt.

Follow-Up Reporting Within One Year

The reporting obligation does not end with the initial submission. If the Responsible Person receives medical or other information about a previously reported serious adverse event within one year of the initial FDA report, that new information must be submitted to FDA within 15 business days.

This means companies need processes not only for initial intake and reporting but also for monitoring open cases and flagging when new information arrives that applies to a previously submitted report.

How to Submit Reports to the FDA

FDA currently accepts serious adverse event reports for cosmetics from industry via electronic submissions or a MedWatch Form 3500A. The electronic submission method includes the Electronic Submissions Gateway (ESG) in XML format or the Safety Reporting Portal (SRP). The other option includes a MedWatch Form 3500A, where the completed form, along with supporting materials such as label copies and any relevant images, should be submitted by email to [email protected] or by mail to:

FDA CDER Mail Center
Attn: Cosmetics MedWatch reports
White Oak Campus, Building 22, G0207
10903 New Hampshire Ave.
Silver Spring, MD 20993

Each report must include a copy of the label on or within the retail packaging of the cosmetic product. Here are the updated FDA instructions for Form 3500A to make it easier for cosmetics companies to complete.

Recordkeeping and FDA Inspection

MoCRA requires Responsible Persons to maintain records of adverse events and make them available to FDA upon inspection or request. The retention period is six years for standard businesses and three years for small businesses (as defined under the statute).

Records should include documentation of adverse events received (serious and non-serious), copies of all FDA submissions and follow-up communications, internal evaluation and assessment records, and any product information relevant to reported events. Maintaining organized, readily accessible records demonstrates due diligence and supports a smoother inspection process if FDA requests access.

Companies should also ensure that MoCRA adverse event recordkeeping systems are distinct from those used for other regulated products such as drugs or dietary supplements, since MoCRA requirements differ from DSHEA, Medical Device Reporting (MDR), and drug reporting frameworks in meaningful ways.

Building Operational Systems for MoCRA Compliance

Adverse event reporting compliance under MoCRA depends on operational systems that work consistently across intake channels, evaluation, documentation, submission, and follow-up. Companies at various stages of building these capabilities often find it useful to evaluate several areas:

• Intake coverage: Do all customer-facing channels (phone, email, website, social media) have processes for capturing and triaging adverse event reports?
• Clinical triage: Is there a consistent process for evaluating whether reported events meet the serious adverse event threshold, including access to qualified medical reviewers?
• Timeline management: Are deadline tracking systems in place for both initial reports and follow-up submissions within one year?
• Documentation: Are records being retained in a format that can be produced for FDA inspection?
• Staff training: Have staff involved in intake and reporting been trained on MoCRA's requirements?

Whether a company builds these capabilities internally or works with a specialized partner, having documented processes is important both for consistent compliance and for demonstrating that approach to regulators.

We work with companies across multiple regulated industries to build adverse event management programs tailored to their specific product categories and regulatory requirements. If you're evaluating your current approach or building a new program, we can discuss what makes sense for your situation.

Building Operational Systems for MoCRA Compliance

The following FDA sources were used in developing this content. We recommend consulting these directly for the most current guidance, as FDA updates its guidance documents and web content periodically.

1. FDA, "Modernization of Cosmetics Regulation Act of 2022 (MoCRA)" – FDA.gov MoCRA overview page
2. FDA, "FDA Issues Updated Instructions for Serious Adverse Event Reporting for Cosmetic Products," Constituent Update, December 14, 2023 – fda.gov/cosmetics/cosmetics-news-events/fda-issues-updated-instructions-serious-adverse-event-reporting-cosmetic-products
3. FDA MedWatch Form 3500A (mandatory reporting form) – fda.gov/safety/medwatch
4. FDA, [email protected] – current submission email for cosmetic serious adverse event reports

Note for reviewers: Please verify that submission email address and form version are current at time of publication, as these have changed since MoCRA's initial implementation.