Serious Adverse Event Reporting Under MoCRA

Under the Modernization of Cosmetics Regulation Act (MoCRA), reporting serious adverse events to the FDA is now mandatory. Companies must report serious incidents—such as hospitalizations, infections, disfigurement, or medically treated allergic reactions—within 15 business days. They must also maintain records of all adverse events for six years (or three years for small businesses).

Practically, this requires setting up a system to capture and assess customer complaints, determine seriousness, and document actions taken. Beyond compliance, this serves as a safety and trust mechanism—helping protect consumers, prevent regulatory actions like warning letters or recalls, and strengthen brand credibility.

For further guidance, contact the Kulkarni Law Firm.

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