at the end the following: 611. Adverse event reporting for cosmetics (a) In general With respect to any cosmetic product distributed in the United States, the responsible person shall submit to the Food and Drug Administration a report of any serious adverse event associated with such cosmetic product, when used in the United States, accompanied by a copy of the label on or with the retail packaging of the cosmetic, any new medical information, related to a submitted serious adverse event report that is received by the responsible person, and an annual report for all adverse events received by the responsible person. (b) Definitions In this section: (1) An adverse event for a cosmetic product is a health-related event associated with the use of this product that is adverse. (2) A serious adverse event for a cosmetic product is an adverse event that— (A) results in— (i) death