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98. in FDCA prosecutions

In reviewing any model jury instructions and charging documents, be aware that the Ninth Circuit in 2002 held that "materiality" is an element of a felony offense under 21 U.S.C. § 333(a)(2). United States v. Watkins, 278 F.3d 961 (9th Cir. 2002). The opinion follows Neder v. United States, 527 U.S. 1 (1999), and disagrees with United States v. Jorgensen, 144 F.3d 550 (8th Cir. 1998), which interprets an analogous statute as not imposing a "materiality" requirement. Watkins, like Neder, relies on the common law meaning of "fraud" and "mislead."

The same issue was before the Seventh Circuit in United States v. Bhutani, 266 F.3d 661 (7th Cir. 2001), cert. den., 122 S. Ct. 2587 (2002). However, the Seventh Circuit did not address the issue, so Watkins is the first post-Neder FDCA opinion on "materiality." In Jorgensen, the Eighth Circuit rejected a materiality requirement for the Federal Meat Inspection Act, which is a statute modeled on the FDCA. Watkins, on the other hand, held that "materiality must be proven as an element of the offense under either a theory of intent to defraud or a theory of intent to mislead." Id. at 963.This result dictates how "intent to defraud or mislead" must be approached in districts in the Ninth Circuit. Moreover, care must be exercised in dealing with "materiality" elsewhere. Because felony prosecutions generally involve material falsehoods, the safer course is to include "materiality" allegations in indictments and in jury instructions. (With respect to any existing cases in which Watkins is used to challenge an indictment or conviction, please consult with the Office of Consumer Litigation for briefs and analysis of the "materiality" issue in the FDCA context. There are arguments why "materiality" need not be a separate element under the FDCA.)

[cited in USAM 4-8.205] [Added November 2002]

Updated June 4, 2015