Manufacturers, beware. FDA has announced plans to utilize the Park Doctrine to bring misdemeanor charges against CEOs and other corporate officers for violations of the Food, Drug and Cosmetic Act. The agency says that it will begin to put increased pressure on federal prosecutors to take misdemeanor cases, hoping that the fear of conviction will be an effective deterrent against criminal behavior.

The Park Doctrine allows the government to hold corporate officers, including but in no way limited to CEOs, accountable for misdemeanor violations regardless of whether or not they had prior knowledge of any wrongdoing. The central principle of the Doctrine is that even if they did not know a violation was being committed, a corporate official, just by virtue of their post, has the power to prevent it.

The Park Doctrine may prove to be a powerful tool for FDA, whose officials have indicated that government sanctions have not been effective in preventing criminal behavior, specifically citing the prevalence of off-label marketing within the pharmaceutical industry. Under the Park Doctrine, prosecutors will have no obligation to prove that a defendant had intent to commit a violation, prior knowledge of a violation, or engaged in negligent conduct. The fact that the defendant is a corporate officer will be enough for the prosecution to gain a conviction.

FDA will most likely begin by targeting off-label promotion within the pharmaceutical industry in its initial cases; however the use of the Park Doctrine sets a new precedent in the manner in which FDA will be pursuing violations. It would not be surprising to see supplement companies pursued in the coming months and years. This move from the FDA should be taken as a wake-up call for the pharma and supplement industries to take decisive action while they’re ahead. Companies that make the decision to be proactive and take a close look at their products and procedures may ultimately escape a potentially costly and embarrassing legal situation further down the road.