(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 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.
Notes of Decisions
Dimare Fresh, Inc. v. United States (2015)
cafc · cites it 2×
“In interpreting what constitutes “imminent danger” or “hazard” to the public health, the FDA promulgated 21 C.F.R. § 2.5 . Subsection (a) of that provision reads: Within the meaning of the Federal Food, Drug, and Cosmetic Act an imminent hazard to the public health is considered…”
Forsham v. Califano (1977)
dcd · cites it 2×
“And, even if there may exist some discrepancy between the Secretary’s criteria and those set forth in 21 CFR § 2.5 , we would note that the regulation was designed to guide the FDA Commissioner in making his recommendations to the Secretary with respect to the existence of an…”
Fisher Bros. Sales v. United States (1995)
ca3 · cites it 2×
“§ 375 (b); see also 21 C.F.R. § 2.5 (a). FDA regulations also permit the Commissioner of the FDA to initiate a "recall" of food in distribution channels where the food presents a risk of injury to consumers and recall is needed to protect the public health.”
— 21 C.F.R. § 2.5(b) — 1 case
Forsham v. Califano (1977)
dcd
“And, even if there may exist some discrepancy between the Secretary’s criteria and those set forth in 21 CFR § 2.5 , we would note that the regulation was designed to guide the FDA Commissioner in making his recommendations to the Secretary with respect to the existence of an…”
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