§379v — Title 21 Food and Drugs | U.S. Code

Summary

Safety reports or other safety information about a product — including foods, drugs, devices, dietary supplements, or cosmetics — that a company files or that the Secretary releases must not be treated as proof that the product failed or that it caused or helped cause a harmful event, such as death, serious injury, or serious illness. The company that sent the report does not have to admit that the report is proof of such harm and can say it is not an admission.

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.

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.

§379v Safety Report Disclaimers

Summary

Title 21, §379v

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Effective Date

Effective Date

Citations & Metadata