MoCRA Adverse Event Reporting: What Foreign Cosmetic Brands Must Track and Report to the FDA

The Modernization of Cosmetics Regulation Act introduced the first mandatory adverse event reporting system for cosmetics in US regulatory history. Before MoCRA, the FDA had no systematic mechanism for collecting safety data on cosmetic products — adverse event reporting was entirely voluntary, and most cosmetic companies had no formal system for tracking consumer complaints related to product safety. Under MoCRA, the responsible person for a cosmetic product must report every serious adverse event to the FDA within 15 business days of receiving the report, must maintain records of all adverse events (serious and non-serious) for six years, and must include contact information on the product label for consumers to report adverse events. For foreign cosmetic brands selling in the US market, this means building a pharmacovigilance-like system for their cosmetics — something most cosmetic companies have never had to do before.

What constitutes a serious adverse event

Under MoCRA, a serious adverse event 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 a medical or surgical intervention to prevent one of these outcomes. This definition is broad enough to cover severe allergic reactions requiring emergency treatment, chemical burns, serious skin infections attributed to contaminated products, respiratory events caused by aerosol products, and eye injuries from products used in the eye area. Mild reactions — temporary redness, slight irritation, subjective complaints about product performance — are not serious adverse events under MoCRA, but they must still be recorded and maintained in the company's adverse event files.

The 15-business-day reporting timeline

The responsible person must submit a report of a serious adverse event to the FDA within 15 business days of the date on which the report is received. The report is submitted through FDA's MedWatch Safety Reporting Portal using Form FDA 3500A or an equivalent electronic submission. The report must include the product name, the responsible person's contact information, a description of the serious adverse event, and a copy of the product label. After the initial report, the responsible person must submit any new medical or safety information that becomes available within one year of the initial report. The 15-business-day clock begins when the responsible person first receives the adverse event report — not when the responsible person confirms the event or completes an investigation. Waiting to investigate before reporting will result in a late submission, which is a violation of MoCRA.

Record-keeping requirements

MoCRA requires the responsible person to maintain records of all adverse events — not just serious ones — associated with the use of their cosmetic products. These records must be maintained for a period of six years (three years for small businesses). The records must include sufficient information to identify the product, the nature of the adverse event, the date the report was received, and any actions taken. The FDA may request access to these records during inspections or investigations, and failure to maintain adequate records is itself a violation of MoCRA. Foreign brands that sell through US distributors must establish clear agreements about who receives consumer complaints, how those complaints are forwarded to the responsible person, and how the records are maintained.

Label contact information requirement

MoCRA requires that the label of every cosmetic product include a domestic address, domestic phone number, or electronic contact (email or website) through which consumers can report adverse events. This contact information must be for the responsible person or a designated contact who will forward reports to the responsible person. For foreign brands, this typically means listing the US distributor's contact information or the contact information of an entity designated to receive adverse event reports on the brand's behalf. The contact information must be monitored — a phone number that goes to voicemail indefinitely or an email address that bounces does not satisfy the requirement.

Building an adverse event tracking system

Foreign cosmetic brands entering the US market need to establish a system for receiving, evaluating, reporting, and recording adverse events before their first product is sold. The system should include clear intake procedures — how consumer complaints are received (phone, email, website form, retailer reports), who reviews them, and how they are classified as serious or non-serious. It should include an assessment process to determine whether the event is related to the product and whether it meets the serious adverse event definition. It should include a reporting workflow that ensures the 15-business-day FDA reporting deadline is met for serious events. And it should include a record-keeping system that maintains all adverse event files for the required six-year retention period.

How FDABridge helps with MoCRA adverse event compliance

FDABridge provides MoCRA cosmetic facility registration and product listing services that include guidance on the compliance framework foreign brands must build for the US market. Our registration services ensure your facility and products are properly filed with the FDA, which is the foundational step before adverse event reporting obligations begin. Visit fdabridge.com/cosmetics to see our cosmetics services or fdabridge.com/contact to discuss your MoCRA compliance needs.