134.

Sample Trial Brief Re Elements of Violations of the FDCA Contained in 21 U.S.C. § 331(A) and § 331(K)

I. STATUTES INVOLVED AND ELEMENTS OF THE OFFENSES Count One charges XXXXX X. XXXX, XXXXX XXXX, XXX XXXX, and others with conspiracy, in violation of 18 U.S.C. § 371. Indictment, pp. 1-13. Counts 2 through 13 charge the same defendants with mail fraud, in violation of 18 U.S.C. § 1341. Indictment, pp. 14-17. Counts 14 through 33 charge various violations of the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 331(a), 331(k), and 333(a)(2). Indictment, pp. 17-25.[FN1] FN1. Both the mail fraud counts and the "food and drug" counts also charge the defendants with aiding and abetting in violation of 18 U.S.C. § 2. Elements of "Conspiracy" The elements of a conspiracy offense under 18 U.S.C. § 371 are: (1) that two ore more persons conspired, or agreed, to commit the crimes described in the indictment; (2) that the defendants knowingly and voluntarily joined the conspiracy; and (3) that a member of the conspiracy did one of overt acts for the purpose of advancing or helping the conspiracy. Pattern Criminal Jury Instructions, 6th Cir. (1991), 3.01A, 3.01B. Elements of "Mail Fraud" The elements of mail fraud are: (1) that the defendants knowingly and willfully devised or knowingly and willfully participated in a scheme or artifice to obtain money or property by means of false or fraudulent pretenses, representations or promises; (2) that the defendants did so with intent to defraud; and (3) that in advancing, or furthering, or carrying out this scheme to obtain money or property by means of false or fraudulent pretenses, representations, or promises, the defendants used the mails or caused the mails to be used. United States v. Bibby, 752 F.2d 1116, 1125-26 (6th Cir. 1985), cert. denied, 475 U.S. 1010 (1986); Devitt, Blackmar & O'Malley, Federal Jury Prac. & Instructions - Criminal, § 40.03. Elements of the "Food and Drug" Violations The indictment charges four different violations of the Food, Drug, and Cosmetic Act. Counts 14 through 21 charge the defendants with introducing into interstate commerce a food which has been adulterated, in violation of 21 U.S.C. §§ 331(a), 333(a)(2). The elements of this offense are: 1) that the defendants caused a food to be introduced or delivered for introduction into interstate commerce that was labeled as, or otherwise represented to be, orange concentrate or unsweetened concentrated orange juice for manufacturing; 2) that the food was adulterated when so introduced or delivered for introduction into interstate commerce; and 3) that the defendants acted with the intent to defraud or mislead. United States v. Hiland, 909 F.2d 1114, 1127-28 (8th Cir. 1990); see Roseman v. United States, 364 F.2d 18, 26 (9th Cir. 1966), cert. denied, 386 U.S. 918 (1967). Counts 22 through 29 charge the defendants with unlawfully introducing into interstate commerce a food which has been misbranded, in violation of 21 U.S.C. §§ 331(a), 333(a)(2). The elements are: 1) that the defendants caused a food to be introduced or delivered for introduction into interstate commerce that was labeled as, or otherwise represented to be, orange concentrate and unsweetened concentrated orange juice for manufacturing; 2) that the food was misbranded when so introduced or delivered into interstate commerce; and 3) that the defendants acted with the intent to defraud or mislead. Hiland, 909 F.2d at 1127-28; see Roseman, 364 F.2d at 26. Counts 30 and 32 charge that the defendants adulterated a product that was held for sale and had at least one component travel in interstate commerce, in violation of 21 U.S.C. §§ 331(k), 333(a)(2). The elements are: 1) that one of the components of the food being held for sale was shipped in interstate commerce; 2) that the defendants caused that food, which was labeled as, or otherwise represented to be, unsweetened concentrated orange juice for manufacturing, to become adulterated while held for sale; and 3) that the defendants acted with an intent to defraud or mislead. See United States v. Sullivan, 332 U.S. 689, 695 (1948). Finally, Counts 31 and 33 charge that the defendants misbranded a product that was held for sale and had at least one component travel in interstate commerce, in violation of 21 U.S.C. §§ 331(k), 333(a)(2). The elements are: 1) that one of the components of the food being held for sale was shipped in interstate commerce; 2) that the defendants caused that food, which was labeled as, or otherwise represented to be, unsweetened concentrated orange juice for manufacturing, to become misbranded; and 3) that the defendants acted with an intent to defraud or mislead. See Sullivan, 332 U.S. at 695. For purposes of Counts 14 through 21, and Counts 30 and 32, a food is adulterated if: 1) a valuable constituent (orange juice concentrate) was, in whole or in part, omitted from a product labeled as, or otherwise represented to be, unsweetened orange juice concentrate, 21 U.S.C. § 342(b)(1); or 2) some other substance (such as beet sugar or syrup containing sugar) has been substituted, in whole or in part, for orange juice concentrate in a product labeled as, or otherwise represented to be, unsweetened concentrated orange juice for manufacturing, 21 U.S.C. § 342(b)(2). For purposes of Counts 22 through 29, and Counts 31 and 33, a food is misbranded if: 1) its labeling was false or misleading because the labeling represented or suggested that the food consisted only of unsweetened orange juice concentrate when the food actually contained beet sugar or syrup containing sugar, 21 U.S.C. § 343(a)(1); or 2) the food was offered for sale as unsweetened concentrated orange juice for manufacturing was really beet sugar, 21 U.S.C. § 343(b); or 3) the food represented to be concentrated orange juice for manufacturing failed to conform to the definition and standard for identity for concentrated orange juice for manufacturing as set forth by the FDA in a published regulation, in that it was composed in part of an ingredient not permitted by the definition and standard of identity, including beet sugar (without a labeling statement), 21 U.S.C. § 343(g); 21 C.F.R. § 146.153. [cited in USAM 4-8.240]