I received a lot of email and calls from folks today wanting to get some understanding of what might be facing The Peanut Corporation of America (PCA). Here are my thoughts:
The Federal Food, Drug, and Cosmetic Act was passed by Congress in 1938 in reaction to the growing public safety demands. The primary goal of the Act is to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce. Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if, inter alia, the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance which may render it injurious to health. If, however, the “poisonous or deleterious” substance is not an added substance, the food is not considered adulterated if the quantity of the substance in the particular food item does not ordinarily render the food injurious to health.
The Act authorizes factory inspections and added injunctions to the enforcement tools at the Food and Drug Administration’s (FDA) disposal. Following hearings in the early 1950s, a series of laws addressing pesticide residues (1954), food additives (1958), and color additives (1960) gave the FDA much tighter control over the growing list of chemicals entering the food supply, putting the onus on manufacturers to establish their safety. The Act stands today as one of the primary means by which the federal government enforces food and pharmaceutical safety standards.
Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions state that:
- Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce. Any person who commits a prohibited act violates the FDCA. A person committing a prohibited act "with the intent to defraud or mislead" is guilty of a felony punishable by three years imprisonment.
- A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct. Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation. Convictions under the misdemeanor provisions are punishable by up to one year imprisonment or a $1000 fine.
The Act also includes provisions for individual liability, specifically. Individuals who are responsible for criminal behavior are normally named as defendants along with corporate entities through which crimes are committed. A corporate defendant’s willingness to enter a plea of guilty is accordingly not a basis for dismissal of charges against an individual. Individual defendants are generally the highest ranking officials in a firm who made decisions that violated the law, along with others who actively participated in fraudulent activity. Thus, presidents of corporations and managers of facilities where violations take place are often appropriate defendants.
One thing to remember, before we try and convict PCA, is that in 15 years of involvement in every major foodborne illness case, there have been only a handful of prosecutions and fewer convictions. This has been true in cases involving acts as egregious or more so than those of PCA. Not to say they should not be prosecuted, just remember to keep in in context.
Carol Benjamin and Betsy J. Floman, Federal Food and Drug Act Violations, 31 Am. Crim. L. Rev. 629 (1994).
21 U.S.C. §331.
21 U.S.C. §333(a)(2).
See United States v. Park, 421 U.S. 658, 674-77 (1975); United States v. Dotterweich, 320 U.S. 277, 280-81 (1943).
See United States v. Marcus, 82 F.3d 606 (4th Cir. 1996) (President/CEO of generic drug manufacturing firm prosecuted for altering heart medication formula without adequate testing or FDA approval); United States v. James V. Mays, 77 F.3d 906 (6th Cir. 1996); United States v. Samuel and Patsy Mays, 69 F.3d 116 (6th Cir. 1995), cert. denied, 116 S. Ct. 2504 (1996) (President, Secretary/Treasurer, and Operations Manager of juice concentrate company prosecuted for secretly adding 20,000,000 pounds of sugar to product sold as pure 100% orange concentrate).