In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm covers how cosmetic brands should handle consumer complaints and adverse events under FDA requirements. Watch below, then read the full transcript.
Full Transcript
For cosmetic brands, consumer complaints are more than a customer service issue — they are a compliance obligation. Under the Modernization of Cosmetics Regulation Act, FDA now requires cosmetic companies to maintain processes for receiving, reviewing, and responding to complaints related to serious adverse events. A serious adverse event is any adverse health experience associated with your cosmetic product that results in death, life-threatening injury, hospitalization, disability, or requires medical intervention.
When a consumer reports a reaction — whether a rash, irritation, allergic response, or something more serious — FDA expects you to document the complaint in detail, including the product name and lot number, the nature of the reaction, and the date the report was received. From there, your complaint-handling system should require an investigation: identifying potential root causes, evaluating whether the issue is isolated or part of a broader pattern, and determining whether corrective action is needed. Depending on the severity, this could mean updating your formula, revising your labeling, or notifying FDA of a serious adverse event within the required 15-business-day reporting window.
Failing to maintain a complaint-handling system — or ignoring adverse event reports — is one of the fastest ways to attract FDA scrutiny. Warning letters and enforcement actions often follow patterns of inadequate complaint investigation. A well-designed system does not need to be complicated. It needs to be consistent, documented, and aligned with FDA expectations. Building these systems proactively protects your brand and your customers.
👉 Contact Capote Law Firm today for expert FDA compliance guidance on cosmetic adverse event reporting and complaint handling.