(L-R): Michael Blume, Director, Consumer Protection Branch, U.S. Department of Justice, and Doug Fellman, Partner, Hogan Lovells US LLP
One of the best attended sessions at IDFA’s Regulatory RoundUP last week was “The Food Police: Under Investigation.” Michael Blume of the U.S. Department of Justice (DOJ) and Doug Fellman, a partner at Hogan Lovells US LLP, provided intriguing insight and instructions for dairy industry employees if their companies become involved in criminal investigations related to food safety.
Blume, who is director of DOJ’s consumer protection branch, noted that the department is becoming more involved in enforcing laws under the Food, Drug and Cosmetic Act and explained how investigations start. Although more than half of the cases are referred by the Food and Drug Administration, a large minority of cases are started by DOJ based on a series of criteria, including:
- Was or is there harm, such as serious illness or death, to consumers?
- Has the company had previous violations or engagement with the government on similar issues?
- Does the incident warrant the sending of a signal as a general deterrent to the industry at large?
DOJ doesn’t have a formalized policy for opening investigations, Blume said, so individual offices and prosecutors have the discretion to determine whether an investigation is warranted. These offices also can decide whether to bring criminal action against individual employees or owners of companies under investigation based on the culpability of the employee and what he or she could have done differently to avoid the food safety issue, among other criteria.
Control Conversations and Protect Evidence
Fellman, the attorney, outlined several important action steps for companies who are contacted by FDA or DOJ about a food safety investigation. Companies should:
- Have the proper employees handing the conversations. They must be extremely accurate and precise in what they say to investigators, without speculating or guessing on answers.
- Handle the interactions in a controlled way. Record the conversations and have two employees involved at all times.
- Keep copies of all information provided to the agency or department.
- Get cards from all investigators so it’s clear which divisions are involved.
- Treat the agents with respect.
The most important thing a company can do, Fellman said, is preserve evidence and documents. He called it a cardinal sin to let documents disappear or get deleted.
Noting that a culture of food safety starts at the top, Fellman urged executives and board members to demonstrate and reinforce their commitment to food safety throughout the company and to all employees. He encouraged plant managers to start every shift by saying, “Remember: Food safety is our number one priority.” Employees should be rewarded for addressing and working on food safety issues, too, he said.
For more information, contact Emily Lyons, IDFA director of regulatory affairs and counsel, at firstname.lastname@example.org.