Sec. 104. Adverse event reports
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Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq.), as amended by section 103(a), is further amended by adding at the end the following: With respect to any cosmetic product distributed in the United States, the responsible person shall submit, not later than 15 days after the receipt by the responsible person, using an electronic system developed under subsection (b), to the Secretary any report of a serious adverse event associated with the use of the cosmetic product, accompanied by a copy of the label on or with the retail packaging of the cosmetic product.
During the 12-month period following the submission of a serious adverse event report under paragraph (1), with respect to any cosmetic product distributed in the United States, the responsible person shall submit, not later than 15 days after the receipt by the responsible person, using an electronic system developed under subsection (b), to the Secretary any new medical information related to such serious adverse event report that is received by the responsible person . The Secretary shall make publicly available on the internet website of the Food and Drug Administration reports submitted under paragraph (1).
In the case of cosmetic product that is also a drug for which a serious adverse event report is filed using Form FDA 3500A (or any successor form developed for such purpose) or its electronic equivalent for over-the-counter drugs, the responsible person shall not be required to submit a serious adverse event report under paragraph
(1)with respect to that cosmetic product. The Secretary shall, not later than 1 year after the date of enactment of the Cosmetic Safety Enhancement Act of 2019 , develop and implement an electronic system for use for the submission of serious adverse event reports under this section. The format of the electronic system developed and implemented under paragraph
(1)may be modified by the Secretary and the reports may include additional information. The Secretary may, in guidance, further specify the format and contents of required reports. A serious adverse event report submitted under paragraph
(1)of subsection
(a)shall include all information submitted with the initial report and any information subsequently added to such report pursuant to paragraph
(2)of such subsection and— any report by the responsible person under section 756 with respect to the safety of the cosmetic product that is the subject of the report; information on the individual or individuals with respect to whom the adverse event report is submitted, in accordance with the disclosure requirements of section 552a of title 5, United States Code; notwithstanding section 552(b)(6) of title 5, United States Code, medical (or similar) documentation of the serious adverse event that is the subject of the report, with all personally identifiable information redacted; and contact information for the individual or individuals reporting the serious adverse event. After an individual initiates the reporting of a serious adverse event, the responsible person for the cosmetic product shall actively gather all of the information reasonably available to such person to complete and file the report with the Secretary under subsection (a)(1). The Secretary shall provide an option as part of the electronic registration process for the responsible person to indicate if such responsible person had no adverse events to report over the previous year. With respect to a responsible person who received no adverse event reports for a year, the annual adverse event report requirement may be met by indicating no such events on the annual registration form. The Secretary may establish by regulation an exemption to any of the requirements under this section if the Secretary determines that such exemption is supported by adequate evidence and would have no adverse effect on public health. Each responsible person shall maintain records related to each report of an adverse event (including serious adverse events) associated with each cosmetic product marketed by such responsible person and received by such responsible person for a period of 6 years. Such records shall be made available to an officer or an employee duly designated by the Secretary upon request, at reasonable times and within reasonable limits and in a reasonable manner, including allowing electronic access and to copy such records. Records required to be maintained under this paragraph shall contain all information reasonably available, including— a summary of all adverse events received during the calendar year for each cosmetic product marketed; a complete list of individual reports of adverse events for each cosmetic product marketed and with respect to each such event, the same information required to be included in a report with respect to a serious adverse event under subsection (b)(2), subject to the same conditions with respect to the disclosure of such information; an estimate of the total number of product units estimated to have been distributed to consumers during the period specified in paragraph (1); and such other information as may be specified in regulation or guidance issued by the Secretary. This section shall not be construed to require the inclusion in any report under this section any consumer complaint that concerns solely efficacy and does not contain any information about an adverse event. Section 756 shall apply with respect to the submission of an adverse event report in compliance with subsection (a). The label of a cosmetic product shall bear the domestic address, and either the domestic telephone number or electronic contact information, through which the responsible person may receive a report of an adverse event. The Secretary shall make records submitted under this section available to any State, upon request, to the extent permissible under the laws governing disclosure of information by the Secretary. Information disclosed to a State that is exempt from disclosure under section 552(b)(4) of title 5, United States Code, shall be treated as a trade secret and confidential information by the State. Such State and its employees in possession of such information shall be subject to the same laws governing information disclosure as employees of the Food and Drug Administration. A serious adverse event report submitted to the Secretary under subsection (a), including any new medical information submitted under paragraph
(2)of such subsection, or an adverse event report voluntarily submitted to the Secretary, shall be considered to be a safety report under section 756 and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event. The requirement under this section to report serious adverse events shall become effective on the date that the Secretary publicizes the availability of the electronic system described in subsection (b)(1). The requirement under this section to maintain records relating to adverse events which are not serious adverse events shall become effective 18 months after the date of the enactment of the Cosmetic Safety Enhancement Act of 2019. In this section: The term adverse event means, with respect to a cosmetic product, a health-related or medical event associated with the use of such product, including a risk of illness or injury. Such term does not include any instance of a consumer complaint that such product did not work as advertised or marketed. The term serious adverse event means, with respect to a cosmetic product, an adverse event that— results in— death; a life-threatening experience; inpatient hospitalization; a persistent or significant adverse health condition, disability, or incapacity; congenital anomaly or birth defect; or significant disfigurement, including serious or persistent rashes and infections, burns, or significant hair loss; or requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A). .
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Sec. 104
Adverse event reports
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