Sec. 6. Serious and unexpected adverse event reporting for cosmetics
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Chapter VI ( 21 U.S.C. 361 et seq.), as amended by sections 3, 4, and 5, is further amended by adding at the end the following: The Secretary shall by regulation require that a domestic or foreign manufacturer, packer, or distributor whose name appears on the label pursuant to section 602(b)(1) of a cosmetic marketed in the United States submit to the Secretary under subsection
(b)a report containing— information received concerning any serious and unexpected adverse event in the United States allegedly associated with the use of the cosmetic for which it is reasonably likely that the adverse event was caused by the cosmetic when used as recommended or suggested in the labeling; and a copy of the label for the cosmetic. A report on an adverse event under subsection
(a)shall be submitted to the Secretary not later than 15 business days after information concerning the adverse event is received at the place of business labeled on the cosmetic pursuant to section 602(b)(1). A report under subsection
(a)shall include all of the following information: An identifiable patient. An identifiable reporter. A suspect cosmetic or component thereof. A serious adverse event. The person submitting a report under subsection
(a)may— include pertinent information in addition to the information listed in subsection (c); and after submitting the initial report, supplement the report with additional information. A serious and unexpected adverse event report (including all information submitted in the initial report or added later) submitted under subsection (a)— shall be considered to be a safety report under section 756 that is subject to the provisions of that section; and shall be considered to be a record about an individual under section 552a of title 5, United States Code, and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5, and shall not be publicly disclosed unless all personally identifiable information is redacted. The submission of a serious and unexpected adverse event report in compliance with subsection (a)— shall not be construed as an admission that the cosmetic involved caused or contributed to the adverse event; and may be accompanied by a statement that denies that the report constitutes an admission that the cosmetic involved caused or contributed to the adverse event. In releasing any report under subsection
(a)or portion thereof for public disclosure, the Secretary shall include any statement under paragraph (2)(B). The label of a cosmetic shall bear the domestic telephone number, email address, or mailing address through which the person whose name and place of business appear on the label may receive a report of a serious adverse event. The Secretary may, by regulation, establish an exemption to the requirements under subsections
(b)and
(d)if the Secretary determines that such exemption would have no adverse effect on public health. In this section: The term serious , with respect to an adverse event, means— resulting in— death; a life-threatening experience; inpatient hospitalization; a persistent and significant disability or incapacity; a congenital anomaly or birth defect; or permanent disfiguration; or requiring, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A). The term unexpected , with respect to an adverse event, means not identified on the cosmetic label. . Section 602 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 362 ) is amended by adding at the end the following: If it is a cosmetic that is marketed in the United States, unless the label of such cosmetic includes a domestic address or domestic phone number through which a report of a serious and unexpected adverse event (as such term is used in section 607) associated with the use of such cosmetic may be submitted to the person described in section 607(f). .
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