What does the phrase "Serious Adverse Events" mean when referring to cosmetic products?

According to MOCRA - FDA regulations on the import and sale of cosmetic products to the USA, the definition of a serious adverse event related to the use of a cosmetic product in the American market is an adverse reaction that results in:

• the death of the cosmetic product user;
• a life-threatening situation;
• hospitalization;
• a persistent or significant disability;
• a congenital anomaly or birth defect;
• an infection;
• a significant disfigurement (including severe and persistent rashes, second or third-degree burns, significant hair loss, or a persistent or significant alteration of appearance).

A serious adverse reaction also includes the necessity to undergo surgery to prevent any of the serious adverse events described above.

The Food and Drug Administration (FDA) has recently updated the guidelines for reporting serious adverse events associated with the use of cosmetic products in the American market. This update follows the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which comes into effect starting December 29, 2023, and applies to all cosmetic products imported into the United States.

Procedure for reporting Serious Adverse Reactions to the FDA related to the use of cosmetic products imported and sold in America

The responsible person for MOCRA registration must report to the FDA any serious adverse events and reactions associated with the use of cosmetic products in the United States within 15 working days of becoming aware of the event or serious adverse reaction. The responsible party must include a copy of the cosmetic product's label in question. Additionally, if the responsible party receives further medical or other information related to the adverse event within one year of the initial report to the FDA, they must submit this new information to the FDA within 15 working days.

The term "responsible party" refers to the manufacturer, packer, exporter, importer, or distributor of cosmetic products in the American market whose name appears on the cosmetic product's label in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.