Consumer safety officials and federal prosecutors want to make this clear: lying to a U.S. Food and Drug Administration inspector is a crime.
U.S. Justice Department and FDA officials on February 21 trumpeted obstruction of justice charges in announcing criminal allegations rooted in the salmonella outbreak of tainted peanut products in 2009 that sickened hundreds of people across the country. Big-firm lawyers with FDA practice groups noted the "striking" allegations levied in the case, including the federal charges against several individual executives.
Four former officials of Peanut Corporation of America, including the company’s former president, were charged in federal district court in Albany, Georgia, for their alleged roles in distributing salmonella-laced food and deceiving consumers about the presence of salmonella in peanut products. Under federal law, it’s illegal to introduce an "adulterated" food—including a tainted product or food that was produced or handled in an unsanitary manner.
"When those responsible for producing or supplying our food lie and cut corners, as alleged in the indictment, they put us all at risk," Stuart Delery, the acting head of DOJ’s Civil Division, said in a statement. The department, he said, "will not hesitate to pursue any person whose criminal conduct risks the safety of Americans who have done nothing more than eat a peanut butter and jelly sandwich."
Stewart Parnell, the company’s former owner and president, Michael Parnell, a food broker who worked on behalf of the peanut company, and operations manager Samuel Lightsey were charged in U.S. District Court for the Middle District of Georgia with crimes that included mail and wire fraud and introduction of adulterated food into the marketplace.
A fourth official, Mary Wilkerson, who served as the company’s quality assurance manager, was also named as a defendant. Daniel Kilgore, a manager charged in an information for his role in the fraud conspiracy, has pleaded guilty, DOJ officials said. Court records did not reveal whether any of the defendants have retained counsel. Peanut Corporation of America is no longer in business.
"The confluence of important government enforcement priorities in this case is striking: serious allegations regarding food safety, an opportunity to attempt to hold individuals responsible, and the integrity of quality system documentation and the inspection process," Gibson, Dunn & Crutcher partner Stephen Payne, who practices in FDA and health care compliance, said in an e-mail.
"Manufacturers across the FDA-regulated product spectrum likely will take note of this case as strong reinforcement of the latter two priorities."
The prosecution stems from the outbreak of salmonella in 2009 in peanuts and peanut products. FDA officials and the U.S. Centers for Disease Control and Prevention traced the source to a Peanut Corporation of America facility in Blakely, Georgia.
FDA inspectors visited the peanut roasting facility several times in early 2009, the government said. DOJ and FDA officials said Stewart Parnell, Lightsey and Wilkerson gave "untrue or misleading" information in response to questions from FDA inspectors. The questions concerned, among other things, the scope of testing and the results of such tests.
John Roth, director of criminal investigations at the FDA, specifically highlighted the obstruction charges in the indictment during the announcement of the prosecution.
"The FDA has a number of inspectors—thousands of inspectors—who go out and inspect food plants every day, all year round. They rely on truthful answers to questions that they give," Roth said. "The Department of Justice’s action here vindicates a very important right the FDA takes very seriously."
FDA inspectors, Roth said later, "have the right to get honest answers. When that doesn’t happen we very much appreciate the Department of Justice’s effort to ensure that in future cases people understand the consequences of lying to the FDA."
Obstruction charges rooted in statements made to FDA inspectors are not common. Roth pointed to a case filed in 2012 in which four people were indicted for an alleged conspiracy to distribute thousands of pounds of adulterated Mexican cheese across the country. Prosecutors alleged in that case that the defendants falsely told inspectors that more than 300 cartons of cheese had not, in fact, been sold.
Kathleen Sanzo, who leads the FDA and health care practice at Morgan, Lewis & Bockius, said the prosecution of the peanut company executives highlights the FDA’s increasing scrutiny of food adulteration. The obstruction charges, she noted, are rare.
"The industry makes sure they give accurate documents to the government in terms of inspections. It’s highly unusual for a company to go out of its way to create false documents and make false statements."
Michael Moore, the U.S. attorney for the Middle District of Georgia, told reporters that the Peanut Corporation of America executives "cared less about the quality of the food they were providing to the American people and more about the quantity of the money they were collecting."
Contact Mike Scarcella at firstname.lastname@example.org.