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21 U.S.C. § 364fRecords

submitted 88 years ago by Pub. L. 117-328 to r/title-21-FOOD-AND-DRUGS · 277 words · no verdicts yet

in plain englishAI-generated · not legal advice

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.

(a) In general: If the Secretary reasonably believes a cosmetic product, including one of its ingredients, and any other cosmetic product the Secretary reasonably believes could be affected the same way, is likely adulterated in a way that threatens serious health harm or death, then every responsible person and facility must let a designated officer or employee, after that person shows proper credentials and written notice, access and copy all records about that product and any similarly at-risk product, at reasonable times, within reasonable limits, and in a reasonable way. This access is meant to help the Secretary determine whether the product is adulterated and dangerous. But this power does not reach recipes or formulas, financial data, pricing data, personnel data, except data about the qualifications of technical and professional staff doing work covered by this chapter, research data, except safety substantiation data for the products and ingredients, or sales data, except shipment data about sales. (b) Rule of construction: Nothing in this section limits the Secretary's existing power to inspect records or require recordkeeping under any other part of this chapter, including sections 364a and 364b of this title.
the actual law source: uscode.house.gov ↗public domain
(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.

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.)

history & why it existsrecord from the source credit
  • 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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