Cosmetic Adverse Events Overview

A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States 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 1 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.

A serious adverse event is an adverse event that:

• (A) results in:
  • death
  • a life-threatening experience
  • inpatient hospitalization
  • a persistent or significant disability or incapacity
  • a congenital anomaly or birth defect
  • an infection
  • 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
• (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in (A) above.

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