[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR2.5]
[Page 49-50]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS--Table of Contents
Subpart A General Provisions
Sec. 2.5 Imminent hazard to the public health.
(a) Within the meaning of the Federal Food, Drug, and Cosmetic Act
an imminent hazard to the public health is considered to exist when the
evidence is sufficient to show that a product or practice, posing a
significant threat of danger to health, creates a public health
situation (1) that should be corrected immediately to prevent injury and
(2) that should not be permitted to continue while a hearing or other
formal proceeding is being held. The imminent hazard may be declared at
any point in the chain of events which may ultimately result in harm to
the public health. The occurrence of
[[Page 50]]
the final anticipated injury is not essential to establish that an
imminent hazard of such occurrence exists.
(b) In exercising his judgment on whether an imminent hazard exists,
the Commissioner will consider the number of injuries anticipated and
the nature, severity, and duration of the anticipated injury.
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