104.

Elements of a Misdemeanor Offense Under the FDCA

The essential elements of a misdemeanor offense are that a defendant (1) distributed, or caused the distribution of, a food, drug, device, or cosmetic in connection with interstate commerce as outlined in the statute, and (2) the food or drug was adulterated or misbranded. The Supreme Court has held that corporate officials may be held strictly liable for violations committed by their corporate entity if they stood in a responsible relationship to the violation -- i.e., if they had the power to prevent or correct the violation but failed to do so, regardless of whether they had any personal knowledge of the violation. United States v. Park, 421 U.S. 658, 674-77 (1975). A set of jury instructions drafted for a misdemeanor food adulteration case is included in this manual at 105 Civil Resource Manual at 105. Request 5 in that set deals with the "Park"-liability issue. The various felony jury instructions can be used in misdemeanor prosecutions. The "intent to defraud" element would need to be deleted, and an appropriate instruction explaining the nature of "Park" liability added. A potential instruction in addition to Request 5 is included. See this manual at 106 Civil Resource Manual at 106. PRACTICE TIP: In a felony prosecution, the prosecutor may want to request that the jury be instructed on the lesser-included misdemeanor offense. The defense may also request such an instruction, and is entitled to it unless there is no basis in the evidence for a rationale jury to convict of felony conduct and acquit of misdemeanor conduct. United States v. Mays, 69 F.3d 116, 119 (6th Cir. 1995), cert. denied, 116 S.Ct. 2504 (1996). PRACTICE TIP: Similar principles have been applied under certain other statutes, including the Child Protection Act of 1966 and the Federal Hazardous Substances Act. See this manual at 107Civil Resource Manual at 107. [updated May 1998] [cited in USAM 4-8.210]