The U.S. Food and Drug Administration (FDA) has provided an update to on ongoing activities related to serious adverse event reporting mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which are enforceable starting Dec. 29, 2023.
A responsible person is required to report serious adverse events associated with the use of cosmetic products in the U.S. to FDA within 15 business days. The responsible person must include a copy of the label on or within the retail packaging of such cosmetic product. If the responsible person receives medical or other information about the adverse event within one year of the initial report to FDA, they must submit this new information to FDA within 15 business days.
A responsible person means the manufacturer, packer or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.
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