Sec. 105. Records inspection; mandatory recall authority
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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 104, is further amended by adding at the end the following: Each manufacturer, processor, packer, or holder of a cosmetic shall, at the request of an officer or employee duly designated by the Food and Drug Administration, permit such officer or employee, upon presentation of appropriate credentials and written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy— all records maintained under section 611 and in accordance with the rules promulgated by the Food and Drug Administration under section 610, as applicable; and except as provided in subsection (b), all other records, if the Food and Drug Administration— has a reasonable belief that the cosmetic— is adulterated; has caused a reportable serious adverse event; or contains an ingredient that substantial new scientific information shows may be unsafe when present in a cosmetic; and provides written notice of the basis for the Food and Drug Administration’s reasonable belief described in subparagraph (A).
No inspection authorized by this section shall extend to financial data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this Act), research data (other than safety data) or sales data other than shipment data. The requirements under subsection
(a)apply to records maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location. The Food and Drug Administration shall take appropriate measures to ensure that there are effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the Food and Drug Administration pursuant to this section. 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. This section shall not be construed— to limit the authority of the Food and Drug Administration to inspect records or to require establishment and maintenance of records under any other provision of this Act; or to have any legal effect on section 552 of title 5, United States Code, or section 1905 of title 18, United States Code. . If the Food and Drug Administration determines that there is a reasonable probability that a cosmetic is adulterated under section 601 or misbranded under section 602 and the use of or exposure to such cosmetic is likely to cause serious adverse health consequences or death, the Food and Drug Administration shall provide the responsible person with an opportunity to voluntarily cease distribution and recall such article. If the responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic within the time and in the manner prescribed by the Food and Drug Administration, the Food and Drug Administration may order such person to— immediately cease distribution of such cosmetic; and as applicable, immediately notify all persons— manufacturing, processing, packing, transporting, holding, receiving, distributing, or importing and selling such cosmetic; and to which such cosmetic has been distributed, transported, or sold, to immediately cease distribution of such cosmetic. If a cosmetic covered by a recall order issued under paragraph (1)(B) has been distributed to a warehouse-based third party logistics provider without providing such provider sufficient information to know or reasonably determine the precise identity of such cosmetic covered by a recall order that is in its possession, the notice provided by the responsible person subject to the order issued under paragraph (1)(B) shall include such information as is necessary for the warehouse-based third party logistics provider to identify the cosmetic. Nothing in this paragraph shall be construed— to exempt a warehouse-based third party logistics provider from the requirements of this chapter, including the requirements of this section and section 612; or to exempt a warehouse-based third party logistics provider from being the subject of a mandatory recall order. If the Food and Drug Administration requires a responsible person to cease distribution under paragraph (1)(A) of a cosmetic, the Food and Drug Administration may limit the size of the geographic area and the markets affected by such cessation if such limitation would not compromise the public health. The Food and Drug Administration shall provide the responsible party subject to an order under subsection
(b)with an opportunity for an informal hearing, to be held as soon as possible, but not later than 2 days after the issuance of the order, on the actions required by the order and on why the cosmetic that is the subject of the order should not be recalled. If, after providing opportunity for an informal hearing under subsection (c), the Food and Drug Administration determines that removal of the cosmetic from commerce is necessary, the Food and Drug Administration shall, as appropriate— amend the order to require recall of such cosmetic or other appropriate action; specify a timetable in which the recall shall occur; require periodic reports to the Food and Drug Administration describing the progress of the recall; and provide notice to consumers to whom such cosmetic was, or may have been, distributed. If, after such hearing, the Food and Drug Administration determines that adequate grounds do not exist to continue the actions required by the order, or that such actions should be modified, the Food and Drug Administration shall vacate the order or modify the order. The Food and Drug Administration shall work with State and local public health officials in carrying out this section, as appropriate. In conducting a recall under this section, the Food and Drug Administration shall— ensure that a press release is published regarding the recall, and that alerts and public notices are issued, as appropriate, in order to provide notification— of the recall to consumers and retailers to whom such cosmetic was, or may have been, distributed; and that includes, at a minimum— the name of the cosmetic subject to the recall; a description of the risk associated with such article; and to the extent practicable, information for consumers about similar cosmetics that are not affected by the recall; and ensure publication on the Internet website of the Food and Drug Administration an image of the cosmetic that is the subject of the press release described in paragraph (1), if available. The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner. Nothing in this section shall affect the authority of the Food and Drug Administration to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall under any other provision of this chapter or under the Public Health Service Act. .
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Sec. 105
Records inspection; mandatory recall authority
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