21 U.S.C. § 364f — Records
submitted 88 years ago by Pub. L. 117-328 to r/title-21-FOOD-AND-DRUGS · 277 words · no verdicts yet
If the FDA reasonably believes a cosmetic, or similar products, could cause serious harm or death, inspectors can access and copy the maker's records about it. This does not cover trade-secret recipes, financial data, personnel files, or most sales and research data. This rule does not limit record access the FDA already has under other sections.
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).
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.
Source credit: (June 25, 1938, ch. 675, § 610, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5855.)
- 1938Enacted · Pub. L. 117-328 · 136 Stat. 5855
A history note hasn’t been published yet. The record shows enactment by Pub. L. 117-328 on 1938-06-25.
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