For many corporate executives in the food industry, the U.S. Department of Justice (DOJ’s) increasing focus on prosecuting “responsible corporate officers” under the criminal misdemeanor provision of the Food, Drug, and Cosmetic Act (FDCA) has warranted rapt attention, particularly in light of criminal investigations arising from nationwide contamination outbreaks at companies like ConAgra and Blue Bell Creameries.  Recent remarks by attorneys from the DOJ’s Consumer Protection Branch to industry audiences have underscored the government’s expectation that corporate food executives implement a “culture” of food-safety compliance in their companies, and provide timely, truthful responses to both formal and informal inquiries made by regulators at the Food & Drug Administration (FDA).

In December 2016, Principal Deputy Assistant Attorney General Benjamin Mizer addressed the Food and Drug Law Institute’s Enforcement, Litigation and Compliance Conference, reiterating the DOJ’s ability and determination to bring criminal charges in cases where companies sell contaminated products to consumers.  Separately, in remarks to the United Fresh Produce Association in September 2016, DOJ Assistant Director Jeffrey Steger provided a regulator’s viewpoint regarding several concrete ways that food companies can demonstrate their commitment to safety compliance.
Continue Reading DOJ Officials Offer Guidance for Food Company Execs Looking to Minimize Criminal Exposure

On April 29, 2016, Dole Foods Company announced that the Department of Justice (DOJ) had launched an investigation concerning listeria outbreaks at certain Dole plants.  The investigation comes on the heels of a number of high profile DOJ probes into outbreaks of food-related illnesses, most recently Blue Bell Creameries, and continues the DOJ’s recent trend towards aggressive pursuit of food safety violations and criminal charges against corporate executives.

The federal Food, Drug, and Cosmetic Act (FDCA) creates a strict liability criminal offense arising from the introduction of adulterated food into interstate commerce.  The DOJ may elect to pursue misdemeanor or felony charges based on the nature and seriousness of the violation and the scope of the outbreak.  If the outbreak is a first-time offense or is the result of an unintentional violation, then the DOJ is more likely to pursue misdemeanor charges.  If, on the other hand, the company responsible for the outbreak has repeatedly violated the FDCA or has introduced the adulterated food intentionally or knowingly, the DOJ has not hesitated to bring felony charges.  Importantly, both companies and individual executives may face liability for outbreaks, and company executives may be held vicariously liable and face criminal charges even if they were unaware of the contamination.
Continue Reading DOJ’s Focus on Food Safety and Corporate Executives