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Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
2026-07-06 10:51:44 -04:00

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LegalText 21 U.S.C. § 379v Safety report disclaimers us united_states_code code_section 21 FOOD AND DRUGS 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT 379v 21 U.S.C. § 379v 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/s379v data/legal/raw/us/code/title-21/usc21.xml 25e64b364ead6eb42c8993150224300d6b738a1737d8dac8dbea9f9291f05801 3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1 c2c5358749c8d000cdc43abcdc36069a2c90bd44b53efa413d772594358d8f5b 2026-07-04 official
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21 U.S.C. § 379v - Safety report disclaimers

Text

With respect to any entity that submits or is required to submit a safety report or other information in connection with the safety of a product (including a product that is a food, drug, device, dietary supplement, or cosmetic) under this chapter (and any release by the Secretary of that report or information), such report or information shall not be construed to reflect necessarily a conclusion by the entity or the Secretary that the report or information constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death, serious injury, or serious illness. Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or caused or contributed to a death, serious injury, or serious illness.

(June 25, 1938, ch. 675, § 756, as added Pub. L. 105115, title IV, § 420, Nov. 21, 1997, 111 Stat. 2379.)

Notes

Statutory Notes and Related Subsidiaries

Effective DateSection effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.