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 facility, including a facility owned or operated by a responsible person for a cosmetic product shall, at the request of an officer or employee duly designated by the Secretary, 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, or receive electronically records maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location, including— all records maintained under section 611 and in accordance with the rules promulgated by the Secretary under section 610, as applicable; all records maintained under section 609; any records relating to the list of ingredients in specific fragrances or flavors of a cosmetic product or cosmetic formulation, if requested by the Secretary by means of a written notification; and except as provided in subsection (b), all other records relating to the cosmetic product or cosmetic formulation and to any other cosmetic product or cosmetic formulation the Secretary reasonably believes is likely to be affected in a similar manner, if the Secretary— has a reasonable belief that the cosmetic product or cosmetic formulation— is adulterated; has caused a reportable serious adverse event; or contains an ingredient for which new scientific information shows may be unsafe when present in a cosmetic product or cosmetic formulation; and provides written notice to the responsible person of the basis for the Secretary’s reasonable belief described in subparagraph (A), as applicable.
No inspection authorized by this section shall extend to— recipes, 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 and distribution data; or except as provided in paragraph (2), information related to ingredients in fragrances or flavors of a cosmetic product or cosmetic formulation. The Secretary may obtain information related to the ingredients in fragrances or flavors in an identified cosmetic product or cosmetic formulation only by a request in a written notification provided to the manufacturer pursuant to a for-cause inspection.
In response to such written notification, the manufacturer of such fragrance or flavor shall provide information about the ingredients in the specified fragrance or flavor that the Secretary determines is necessary to assist its investigation, in the manufacturer’s preferred electronic or written format, to the Secretary upon receipt of such notification. Any information provided in response to such written notification shall be considered a trade secret under section 301(j) and, notwithstanding such section, shall only be disclosed if the Secretary determines such disclosure is necessary to protect the public health.
The authority to determine such disclosure is necessary to protect the public health shall not be delegated to any officer or employee other than the director of the applicable office. The Secretary 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 Secretary pursuant to this section. Information disclosed to a State shall be pursuant to the laws governing disclosure of information.
Confidential information disclosed to the State that is exempt from disclosure under section 552(b)(4) of title 5, United States Code, shall be treated as confidential information by the State. Such State and its employees in possession of such information under this section shall be subject to the same laws governing information disclosure as employees of the Food and Drug Administration. This section shall not be construed— to limit the authority of the Secretary to inspect records or to require establishment and maintenance of records under any other provision of this Act; or to require the Secretary to publicly disclose any information that is exempt from disclosure under section 522 of title 5, United States Code, or section 1905 of title 18, United States Code.
If the Secretary determines that there is a reasonable probability that a cosmetic product is adulterated under section 601 or misbranded under section 602 and the use of, and exposure to, such cosmetic product is likely to cause serious adverse health consequences or death, the Secretary shall provide the responsible person with an opportunity to voluntarily cease distribution and recall such article. If the domestic responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic product within the time and in the manner prescribed by the Secretary, the Secretary may order such person to— immediately cease distribution of such cosmetic product; and as applicable, immediately order all facilities— manufacturing, processing, packing, transporting, holding, receiving, distributing, or importing and selling such cosmetic product; and to which such cosmetic product has been distributed, transported, or sold, to immediately cease distribution of such cosmetic product.
In the case of a cosmetic product that is subject to a recall order issued under paragraph (1)(B) with respect to which the responsible person, before the issuance of such order, distributed to a warehouse-based, third-party logistics provider without providing such logistics provider with sufficient information to know or reasonably determine the precise identity of such cosmetic product, the notice provided by the domestic responsible person pursuant to such order shall include such information as is necessary for the logistics provider to identify the cosmetic product.
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 being the subject of a mandatory recall order under this section. If the Secretary requires a domestic responsible person to cease distribution under paragraph (1)(A) of a cosmetic product, the Secretary 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 Secretary shall provide the responsible person 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 product that is the subject of the order should not be recalled. If, after providing opportunity for an informal hearing under subsection (c), the Secretary determines that removal of the cosmetic product from commerce is necessary, the Secretary shall, as appropriate— amend the order to require recall of such cosmetic product or other appropriate action; specify a timetable in which the recall shall occur; require periodic reports to the Secretary describing the progress of the recall; and provide notice to consumers to whom such cosmetic product was, or may have been, distributed. If, after such hearing, the Secretary determines that adequate grounds do not exist to continue the actions required by the order, or that such actions should be modified, the Secretary shall vacate the order or modify the order. The Secretary shall work with State and local public health officials in carrying out this section, as appropriate. In conducting a recall under this section, the Secretary 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 product was, or may have been, distributed; and that includes, at a minimum— the name of the cosmetic product subject to the recall; a description of the risk associated with the use of such cosmetic product; and to the extent practicable, information for consumers about similar cosmetic products that are not affected by the recall; and ensure publication on the internet website of the Food and Drug Administration of an image of the cosmetic product 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 of Food and Drugs. Nothing in this section shall affect the authority of the Secretary to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall any article under any other provision of this Act or under the Public Health Service Act. In this section, the term domestic responsible person means a person who is the domestic contact for a responsible person. .
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Sec. 105
Records inspection; mandatory recall authority
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