Advising Food Company Executives at a Time of Increased Regulatory Risk

Food companies need to be aware of the increasingly litigious environment surrounding food products, which now also includes the risk of criminal enforcement against both the company and its individual executives for violations of the Federal Food, Drug, and Cosmetic Act (FDCA).

Risk for executives is amplified in light of the strict liability, no-intent standard for FDCA violations being invoked by courts nationwide, particularly in cases of egregious behavior, willful negligence, or knowing violations of safety, sanitation and adulteration regulations. Risk also exists where executives should have known about, or could have prevented, the violation but did not do so. Specifically under the Park Doctrine, responsible corporate officers can be held criminally liable without a showing of intent or knowledge, so long as the officer had the authority to prevent or correct the violation. While there is uncertainty as to the trajectory of food regulation, the current FDA administration apparently remains committed to enforcement of the Park Doctrine.

Here are four best practices for in-house counsel: (1) build a defensible, customized compliance plan and conduct routine audits of their own facilities and those of key third party partners; (2) properly staff and train the supply chain, engaging with senior management to assess legal and regulatory implications associated with supply chain risk; (3) address issues of non-compliance including, as essential tools, a crisis management plan and recall protocol; and (4) be prepared for government investigations, understand who owns privilege and who can waive privilege, and reiterate Upjohn warnings as appropriate.