Under the Park Doctrine, who can be held accountable when violations of the FDCA occur?

Under the Park Doctrine, corporate officers can be held accountable for violations of the Federal Food, Drug, and Cosmetic Act (FDCA) irrespective of their knowledge or involvement in the unlawful acts. This legal principle is significant because it ensures that individuals in positions of authority within a company cannot evade responsibility simply because they may not have personally participated in the actions leading to the violation.

The rationale behind holding corporate officers accountable under the Park Doctrine is rooted in the belief that those in leadership roles have a duty to ensure compliance with health and safety regulations. This extends to situations where they may not have had direct knowledge of the violations, reinforcing the idea that corporate officers must actively engage in compliance oversight to protect public health.

In contrast, while other options consider accountability from different perspectives, such as individuals directly responsible, the company itself, or external consultants, none instill the same level of responsibility on corporate officers regardless of their awareness, which is the hallmark of the Park Doctrine.