In the U.S. cosmetics regulatory landscape, the enactment of the Modernization of Cosmetics Regulation Act (MoCRA) represents the most significant shake-up since the original Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938. Among its key new provisions are mandatory serious adverse event (SAE) reporting, expanded record-keeping, facility registration, product listing, and safety-substantiation requirements. This blog examines in detail the adverse-event-reporting component under MoCRA, and outlines what cosmetics manufacturers, packers, distributors and overseas exporters must do to ensure compliance with a particular focus on how Maven Regulatory Solutions can support your regulatory readiness and cosmetovigilance infrastructure.

What is a “Serious Adverse Event” under MoCRA?

Under Section 605 of MoCRA (as incorporated in the FD&C Act), a serious adverse event (SAE) in relation to a cosmetic product is defined as an adverse health-related event 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 (including serious/persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance)

that is not intended under conditions of use customary or usual.
Also, an event that requires medical or surgical intervention to prevent one of the above outcomes is also deemed a serious adverse event.

This definition is broader than previous cosmetic-industry standards and aligns more closely with drug or medical-device adverse-event regimes.

Who is the “Responsible Person” and When Must Reporting Occur?

Responsible Person

The term “responsible person” under MoCRA means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label (in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging & Labeling Act).
Thus, if your company’s name is on the product label, you are responsible for compliance – even if you outsource manufacturing or distribution.

Timing for Reporting

When the responsible person receives information that one of their products has caused or contributed to a serious adverse event in the U.S., they must:

• Submit a SAE report to the U.S. Food and Drug Administration (FDA) within 15 business days of receipt of such information.
• If, within one year of the initial report, the person responsible receives new and material medical or other information about the SAE, they must submit that additional information to the FDA within 15 business days of receipt.
• Reporting must include a copy of the label of the cosmetic product (on or within retail packaging).

Non-Serious Adverse Events

MoCRA does not currently require mandatory submission of non-serious adverse events to the FDA. However, responsible people must receive and record all adverse events (serious + non-serious) and maintain records for inspection.

What Information Must Be Included in the Report?

When submitting a serious adverse event report under MoCRA, the following key elements must be included:

• Patient information (to the extent collected and anonymized as appropriate).
• Details of the event (description, outcome, date of onset, medical treatment, etc.).
• Suspect product information (product name, lot number/SKU if known, packaging, use conditions, etc.).
• Copy of the product label (or packaging showing the label) to be included as supporting documentation.
• Images of the serious adverse event manifestation (where available).
• A statement by the person responsible is optional but permitted: The report may include a statement denying that the product caused or contributed to the event and that it will become part of the FDA’s record.

Record-Keeping, Labeling & Consumer Reporting Obligations

Record-Keeping

Under MoCRA:

• Responsible persons must maintain records of all adverse events (serious and non-serious) for six years, unless they qualify as a “small business”, in which case the period is three years.
• These records must be accessible to the FDA during inspections.

Labeling / Consumer Contact Information

• Each cosmetic product label offered in the U.S. must include the name of the responsible person (already required), plus a domestic address, domestic telephone number, or electronic contact information (e.g., website or email) through which a consumer may report an adverse event.
• The contact information must be sufficiently prominent, so consumers and health professionals can use it to submit reports or complaints.

Intake of Adverse Event Information

• Responsible persons should establish a process for receiving, triaging, investigating adverse-event reports from consumers, health-professionals or other sources.
• The process should include investigation to determine whether the event meets the definition of a serious adverse event and whether it may be reportable to the FDA.

Broader MoCRA-Driven Impacts on the Cosmetics Industry

While adverse-event reporting is a key facet, MoCRA also brings several other regulatory impacts that cosmetics companies must align with, and these have implications on adverse-event readiness and compliance culture.

Facility Registration & Product Listing

• Manufacturers and processors of cosmetic products offered in the U.S. must register their facility with the FDA and renew registration every two years.
• Each cosmetic product must be listed with the FDA annually, including ingredients, person responsible for information, and other product data.

Safety Substantiation

• Responsible people must ensure and maintain records supporting adequate substantiation of safety for their cosmetic products. This means tests, studies, research, analyses or other evidence considered by qualified scientific experts that support a reasonable certainty that the cosmetic product is safe under intended and customary use.
• Although MoCRA does not mandate pre-market approval of cosmetics, safety substantiation must be documented and available for inspection.

Good Manufacturing Practices (GMP) & Mandatory Recall Authority

• MoCRA tasks the FDA with issuing binding GMP regulations for cosmetic manufacturing by December 29, 2025.
• The FDA now has mandatory recall authority if a cosmetic product is found to be adulterated or misbranded and may cause serious adverse health consequences or death.

Implications for Imports & Global Brands

• For brands outside the U.S. that export cosmetics into the U.S., the definition of “responsible person” and the above requirements apply if the product is marketed in the U.S. These brands need to ensure U.S.-based responsible person designation, accurate labeling, adverse-event intake and compliance systems.
• Retailers and importers may now face increased scrutiny, including border / customs holds if facility registration or product listing is not aligned.

Practical Steps for Compliance and Risk Mitigation

Given the enhanced regulatory burden imposed by MoCRA’s adverse-event-reporting regime, cosmetics companies especially those exporting into or manufacturing for the U.S. market should implement the following steps:

1. Identify the Responsible Person
   1. Confirm who is listed on the product label and ensure that the entity assumes the obligations of intake, record-keeping and reporting.
   2. Ensure label contact information (domestic U.S. address, phone or electronic contact) is provided.
2. Establish Adverse-Event Intake & Triage System
   1. Set up standard operating procedures (SOPs) for receiving adverse-event reports from consumers, health-professionals, distributors, retailers.
   2. Train staff to recognize what constitutes a “serious adverse event” under MoCRA.
   3. Create a documented workflow: consumer report → triage/investigation → assessment of seriousness → trigger for reporting to FDA within 15 business days.
3. Prepare Reporting Tools and Documentation
   1. Ensure you have the latest version of Form MedWatch Form 3500A for use when reporting SAEs.
   2. Collect supporting documents: product label copies, images of the event, consumer medical information (with proper consent/security).
   3. Implement secure data collection, storage and retrieval to support investigation and future inspection.
4. Implement Record-Keeping & Trend Analysis
   1. Maintain adverse event records (serious and non-serious) for the required period (six years for most companies; three years for small businesses).
   2. Conduct periodic review of adverse-event data to identify patterns/trends (for example increases in complaint rate, emergence of a new issue), which could trigger corrective action, formulation review or even recall risk.
5. Update Labeling and Product Information
   1. Verify that labels include responsible person contact info (domestic address/phone/email).
   2. Ensure internal systems capture incoming adverse events and tie them back to product SKUs, lots/batches, manufacturing facility, distribution channel.
6. Engage with Maven Regulatory Solutions
   1. Maven can provide expert regulatory support: gap analysis of your current cosmetovigilance system, build/adapt intake/reporting workflows, train personnel on MoCRA reporting timelines, support FDA submission readiness, and act as a U.S. contact if required.
   2. Align your global safety-compliance program with U.S. MoCRA obligations, enabling global brands to manage adverse-event reporting, record keeping, and event-trend management.

       7.   Strategic Implications for the Cosmetics Industry

The introduction of mandatory serious adverse events reporting into the cosmetics sector alters the risk-compliance landscape significantly:

• Elevated regulatory scrutiny: With FDA’s enhanced authority under MoCRA (including inspection, access to records, mandatory recall), cosmetics firms now face similar vigilance as pharmaceuticals/devices.
• Brand-reputation risk: Failure to timely report SAEs can lead to FDA action, product seizure or recall, adverse publicity which can erode consumer trust.
• Operational integration: Adverse-event compliance is no longer just a quality or regulatory matter; it touches manufacturing, labeling/marketing, customer-service, legal, risk-management.
• Global supply-chain alignment: For non-U.S. brands exporting into the U.S., this means implementing U.S.-specific processes and aligning them with global complaint handling and safety monitoring programs.
• Data-driven vigilance: The requirement to keep and evaluate adverse-event records for years means companies will benefit from systems that can flag escalation of event frequencies, enabling proactive product-safety responses rather than reactive only.
• Competitive advantage: Brands that build robust cosmetovigilance systems (intake → investigation → reporting → trend monitoring) will position themselves as premium-safety brands which can be a differentiator in crowded markets.

Conclusion

The launch of MoCRA’s adverse-event-reporting regime marks a new era for cosmetics regulation in the U.S. For cosmetic companies, this is not just a compliance exercise it is a strategic imperative. Establishing a well-structured cosmetovigilance program, aligning product-labeling and consumer-reporting mechanisms, and integrating adverse-event intake, triage and reporting workflows will be key to mitigating risk and safeguarding brand reputation.

At Maven Regulatory Solutions, we help cosmetics companies navigate this regulatory complexity from gap assessment through implementation of intake systems, staff training, submission readiness, and trend-analysis frameworks. If you are exporting your products to the U.S., or are already operating in the U.S. market, now is the time to ensure you are fully MoCRA-compliant.