Based on the information you have provided and the provisions of the Modernization of Cosmetic Regulations Act of 2022 (MoCRA), the following are the important requirements for adverse event reporting involved in FDA registration of a cosmetic product:
By the end of 2024, cosmetic product labels will be required to indicate the contact information consumers can use to submit an adverse event report.
Beginning December 29, 2023, in the event of a serious adverse event related to a cosmetic product, the U.S. responsible person must report such event to FDA within 15 days and submit a copy of the product label with the report.
Serious Adverse Events include deaths, life threatening, infections or hospitalizations requiring medical intervention, persistent or severe disabilities, congenital anomalies, birth defects, or unanticipated serious deformities (including, but not limited to, severe prolonged rashes, infections, second- or third-degree burns, severe hair loss, and persistent or significant cosmetic changes) that result or may result from the use of the product under normal conditions of use.
Requirements for Cosmetic Adverse Event Contacts
The "U.S. Responsible Person" should receive adverse event reports through the U.S. domestic address, domestic telephone number, or electronic contact information shown on the product label.
"U.S. Responsible Persons" are required to manage reports of serious adverse events related to cosmetic products they manufacture, package, or distribute in the U.S. market and submit these reports to the FDA.
Definition and Responsibilities of Responsible Person in the United States
As defined in section 609(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or section 4(a) of the Fair Packaging and Labeling Act, "responsible person in the United States" means a manufacturer, packer, or distributor whose name is listed on the label of a cosmetic product. "U.S. Responsible Person" means the manufacturer, packer, or distributor whose name is listed on the cosmetic label.
The responsibilities of the U.S. responsible person are not limited to adverse event reporting, but extend to the registration of cosmetic products, proof of safety, labeling, disclosure of allergens containing fragrances, and record keeping.
As you can see, the bill requires the cosmetics industry (U.S. responsible persons) to take steps to increase product safety and regulatory transparency to ensure that consumers are protected when using their products and that responsible persons and regulators are notified promptly when problems are detected.
To be in full compliance with MoCRA, practitioners should pay close attention to the correctness of product labeling and promptly address and report any adverse events related to product use. For detailed information on how to implement these regulations, including specific reporting processes and documentation requirements, it is recommended that the Green Circle team be approached to contact the FDA for further guidance.
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