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2026-07-06 10:51:44 -04:00

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LegalText 21 U.S.C. § 364f Records us united_states_code code_section 21 FOOD AND DRUGS 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT 364f 21 U.S.C. § 364f current 119-100 2026-06-26 official https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip /us/usc/t21/s364f data/legal/raw/us/code/title-21/usc21.xml 177a65e1833551e02d0ee8478320fa641784e5f4332b1da70223bde18f684d7a 3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1 231ec8207c9ef7da0980215396caada2abda56a47a2bf58158752b5db09a8409 2026-07-04 official
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21 U.S.C. § 364f - Records

Text

(a) In general 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) Rule of construction 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.

(June 25, 1938, ch. 675, § 610, as added Pub. L. 117328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5855.)

Notes

Statutory Notes and Related Subsidiaries

Construction; ConfidentialityNothing in section 3502 of Pub. L. 117328, 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. 117328, set out as a note under section 364 of this title.