§364f — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary can require a company or facility to let an assigned official look at and copy records about a cosmetic when the Secretary reasonably believes the product (or an ingredient or similar products) is likely contaminated or unsafe and could cause serious harm or death. The official must show ID and give written notice. Inspections must happen at reasonable times, within reasonable limits, and in a reasonable way. The records allowed are only those needed to decide if the product is unsafe. This does not let officials see recipes or formulas, financial or pricing records, most personnel files (except proof of technical or professional qualifications), research records except safety evidence, or sales records except shipment data. It also does not limit the Secretary’s other record-inspection powers under this chapter.

Title 21, §364f

Food and Drugs — Source: USLM XML via OLRC

(a)If the Secretary has a reasonable belief that a cosmetic product, including an ingredient in such cosmetic product, and any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans, each responsible person and facility 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 a 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 relating to such cosmetic product, and to any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans. This subsection shall not be construed to extend to recipes or formulas for cosmetics, financial data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), research data (other than safety substantiation data for cosmetic products and their ingredients), or sales data (other than shipment data regarding sales).

(b)Nothing in this section shall be construed to limit the authority of the Secretary to inspect records or require establishment and maintenance of records under any other provision of this chapter, including section 364a or 364b of this title.

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Statutory Notes and Related Subsidiaries

Construction

ConfidentialityNothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

§364f Records

Summary

Title 21, §364f

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Construction

Citations & Metadata