Federal authorities have brought felony charges against former Peanut Corporation of America officials for their role with the fatal 2009 Salmonella outbreak that sickened over 700 and killed 9. Although this prosecution may be the most significant of its kind to date, it is not the first and it comes as no surprise.
Nearly five (5) years ago, I co-authored an article regarding enforcement actions brought by FDA for violations of the Food, Drug and Cosmetic Act (FD&C). That article contained a discussion of whether the indictment of ChemNutra and its owners was a sign of a more aggressive enforcement strategy undertaken by FDA. As you may recall, based on the efforts of the FDA Office of Criminal Investigation, a federal grand jury indicted ChemNutra and its owners, Sally and Stephen Miller, for their role in importing tainted Chinese wheat gluten thought to be at the root of the U.S. pet food recall in March and April 2007. The indictment alleged violations of FD&C’s sections prohibiting “the introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.” Although the indictment claimed that the Millers knew that the wheat gluten was incorrectly labeled to reflect that it had been subject to inspection upon leaving China, neither was charged with intentionally delivering the adulterated product, nor even with knowing that it was adulterated. The conclusion of my article was that while the indictment of ChemNutra and the Millers may have been surprising because it did not involve allegations of an intentional or knowing violation, it fit squarely within the rubric of cases usually chosen by FDA for prosecution.
Less than a year after that article was published, I authored another article analyzing the likelihood of the criminal prosecution of Peanut Corporation of America (PCA) and its officials for their role in a deadly salmonella outbreak in January 2009. In that article, I concluded that based upon prior FDA-instituted prosecutions, the nature of PCA’s alleged conduct, and the extent of the harm allegedly caused by such conduct, an indictment of PCA was highly likely. Yesterday, over four (4) years after my article was published, federal prosecutors announced a 76-count indictment against former PCA officials, including its owner, Stewart Parnell.
Lawyers for Mr. Parnell claim that PCA never intentionally shipped or caused to be shipped any tainted food products capable of harming PCA’s customers. However, federal prosecutors allege that Mr. Parnell and other PCA officials concealed the presence of salmonella in PCA products for years by including falsified certificates of analysis to show that the products were uncontaminated despite the existence of microbiological test results demonstrating the contrary. Notwithstanding the egregious and intentional conduct alleged by prosecutors and Mr. Parnell’s apparent denials, the ChemNutra indictment reminds us that intent is not a necessary prerequisite for prosecution under the FD&C, although enhanced penalties for violations committed “with the intent to defraud or mislead” do indeed exist.
While it is beyond debate that Mr. Parnell and the other PCA officials against whom the indictment has been brought deserve the full protections afforded them by the U.S. Constitution, if the alleged conduct is proven true, significant punishment is warranted. Such conduct not only has the potential to cause tragic personal and economic consequences, but also serves to undermine consumer confidence in our food supply and casts a shadow on the overwhelming majority of food producers who tirelessly work to deliver safe and nutritious food to our cupboards, day in and day out.