21 U.S.C. § 398

Notices to States regarding imported food

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(a) In general

If the Secretary has credible evidence or information indicating that a shipment of imported food or portion thereof presents a threat of serious adverse health consequences or death to humans or animals, the Secretary shall provide notice regarding such threat to the States in which the food is held or will be held, and to the States in which the manufacturer, packer, or distributor of the food is located, to the extent that the Secretary has knowledge of which States are so involved. In providing notice to a State, the Secretary shall request the State to take such action as the State considers appropriate, if any, to protect the public health regarding the food involved.

(b) Rule of construction

Subsection (a) may not be construed as limiting the authority of the Secretary with respect to food under any other provision of this chapter.

(June 25, 1938, ch. 675, § 1008, formerly § 908, as added Pub. L. 107–188, title III, § 310, June 12, 2002, 116 Stat. 673; renumbered § 1008, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)

Notes of Decisions

Cited in 1 case, 2012–2012 · leading case: Bayer Schering Pharma Ag v. Lupin, Ltd., 676 F.3d 1316 (Fed. Cir. 2012).

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Bayer Schering Pharma Ag v. Lupin, Ltd., 676 F.3d 1316 (Fed. Cir. 2012). “I can’t tell whether the court is holding that the FDA label is fatally flawed, but even if the FDA were somehow remiss (I discern no evidence thereof), this does not render ineffective the patent directed to the combination of these three effects, all of which are set forth in…”

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