MoCRA Updates: U.S. FDA Updates Instructions for Filing out Serious Adverse Event Reports for Cosmetics

Background

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) classifies serious adverse events as those resulting in or necessitating medical intervention to prevent 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 and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual.

Starting from December 29, 2023, cosmetic responsible persons (i.e., the manufacturer, packer, or distributor listed on the product label) are mandated to report serious adverse events to the FDA within 15 days of receipt. The report must be accompanied by a copy of the product label that is printed on or put within the retail packaging. If any "new and material" medical information pertaining to the serious adverse event is received within one year of the initial report, the responsible person must submit this information to the FDA within 15 days of its receipt.

The FDA recommends that cosmetic responsible persons use the existing MedWatch Form 3500A to submit serious adverse event reports for cosmetics, along with providing supporting information such as scans of labels and images of the serious adverse event, which can be submitted to the FDA via email or mail.

On December 14, 2023, the U.S. Food and Drug Administration (FDA) issued updated instructions for MedWatch Form 3500A, the designated form for reporting serious adverse events pertaining to cosmetic products. The revised instructions aim to provide comprehensive explanations and guidance for filling out the MedWatch Form 3500A, facilitating a standardized and simplified process for cosmetic responsible persons reporting serious adverse reactions for cosmetic products.

Additionally, the FDA plans to release additional details regarding the rollout of electronic submission for serious adverse event reports in line with MoCRA requirements in the upcoming months. The agency strongly encourages electronic submission of such reports, highlighting the benefits of efficiency and timeliness in data submission and management.

ChemLinked recommends that companies proactively familiarize themselves with the updated instructions, including the specific content and guidance provided for MedWatch Form 3500A. This understanding is essential for ensuring compliance with MoCRA requirements for reporting serious adverse events.

For more insights into MoCRA, please explore ChemLinked's new Featured page: Navigating US Cosmetic Regulations: MoCRA and Beyond.

Further Reading

• U.S. FDA Launches Cosmetic Direct Electronic Portal for MoCRA
  

• FDA Releases the Final Guidance on Cosmetic Facility Registration and Product Listing for MoCRA