
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC379v]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                    SUBCHAPTER VII--GENERAL AUTHORITY
 
                         Part G--Safety Reports
 
Sec. 379v. Safety report disclaimers

    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, Sec. 756, as added Pub. L. 105-115, title IV, 
Sec. 420, Nov. 21, 1997, 111 Stat. 2379.)


                             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.
