Title 21, Food and DrugsRelease 119-102
§379v Safety Report Disclaimers
Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER VII — GENERAL AUTHORITY › Part G — Safety Reports › § 379v
Summary
Protects a company or person who files a safety report by saying that the report — including any copy the Secretary releases — cannot automatically be treated as proof the product (like a food, drug, device, dietary supplement, or cosmetic) failed or caused death, serious injury, or serious illness. The company or person does not have to admit the report is an admission and can deny that the product caused or contributed to any harm.
Full Legal Text
Title 21, §379v
Food and Drugs, Source: USLM XML via OLRC
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.
Legislative History
Notes & Related Subsidiaries
Statutory Notes and Related Subsidiaries
Effective Date
Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an
Effective Date
of 1997 Amendment note under section 321 of this title.
Reference
Citations & Metadata
Citation
21 U.S.C. § 379v
Title 21, Food and Drugs
Last Updated
Aug 21, 2026
Release point: 119-102