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