[Green Circle Speaks Out] - FDA Cosmetic Adverse Event Contacts

1. Statutory Requirements

The FDA MoCRA Modernizing Cosmetic Regulations Act of 2022 is now in effect. In addition to FDA business registration and product listing, it requires that by December 29, 2024, cosmetic product labels must include adverse event contact information for the purpose of receiving adverse event reports.

2. Adverse incident focal point requirements

The Adverse Event Liaison ensures that consumers are able to readily provide feedback on cosmetic adverse event information to the responsible party and submit serious adverse event reports to the FDA.According to MoCRA, the following information should be included on cosmetic labels:

• Addresses within the United States
• Phone Number or Electronic Contact Information

Contact information must be shown on both the primary and secondary labels. For small-label products such as lipstick, lip gloss, mascara, etc., only telephone or electronic contact options are available.

3. Serious adverse events

An adverse event is any adverse health event related to the use of cosmetics. Serious adverse events are those that cause or require medical intervention to prevent the following conditions

• Death or life-threatening
• Infection or hospitalization
• Persistent or severe disability or incapacity
• Congenital anomalies or birth defects
• Unexpected major disfigurement (e.g., severe rash, second or third degree burns, severe hair loss, etc.)

Beginning December 29, 2023, in the event of a serious adverse event related to a cosmetic product, the responsible person will be required to submit an adverse event report to the FDA within 15 days with a copy of the labeling on or in the retail package, including:

• Patient Information
• Details of Serious Adverse Events and Reassignment
• Suspicious Product Information
• A copy of the label on or in the cosmetic (retail package)

4. Adverse event intake and recording

In addition to reporting Serious Adverse Events, the Responsible Person is responsible for the receipt and documentation of all Adverse Event and Serious Adverse Event reports. Records of adverse event reports must be retained for 6 years (3 years for minor) and FDA must have access to these records during inspections, which should include all reports and related records related to the adverse event.