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Adulterated Foods/Counterfeit Drugs: Punishment Should Fit the Crime

We should all be grateful for the considerable protection we receive from FDA against unsafe food, drugs, devices and other products. This is FDA Matters’ belated but heartfelt Thanksgiving message. Thank you, FDA.

What FDA cannot do alone—and for which we as a society need to step in—is to change the laissez-faire attitude, laws and enforcement affecting intentional contamination and counterfeiting of FDA-regulated products. When Americans die from intentionally tainted milk, counterfeit products or negligently compounded drugs, we need to recognize this as murder. Let’s step treating it as if it were white-collar crime.

Penalties for adulteration of food and brewed products date back as far as the Code of Hammurabi, nearly 4,000 years ago. While unintentional contamination is always a source of potential, even fatal, problems, this is distinct from the widespread and long history of intentional and fraudulent sales of foods as healthful and pure. While not as prominently featured, there is a parallel history of unsafe drugs, devices, cosmetics and other products–now regulated by the FDA and which form a fundamental part of the agency’s history and ongoing mission.  

In recent years, China has gained some notoriety for its particularly strong stance against individuals who intentionally and willfully violated its food and drug laws for their own personal profit. In 2009, two men were executed in China for tainting milk powder with melamine, an industrial chemical. The adulterated milk killed at least six children and reportedly sickened more than 300,000. Those executed were the dairy farmer and milk salesman who were at the center of the scheme. Two years before that, China executed Zheng Xiaoyu, the head of China’s FDA for accepting bribes to allow untested drugs to be approved for marketing.

Leaving aside that many capital crimes in China would not be so here, the offenses involved in the two Chinese examples would certainly appear to merit long jail sentences in the U.S. However, that just doesn’t seem to be the case in the United States—at least looking at the history of food and drug problems in the US over the last 10 years. The massive growth in counterfeit drugs and devices (by definition, intentional crimes of mislabeling and adulteration) only reconfirms the appearance that we are not acting strongly enough to punish people and companies who are intentionally putting Americans at risk.

Why the difference in attitudes? I believe the Chinese would argue that the farmer and the salesman were as responsible as if they had held a gun to the head of six children and murdered them. In the US, the consequence of murdering children in this fashion would likely be execution or life imprisonment. What’s missing in the U.S. (or so it seems) is the understanding that killing people with intentionally tainted food and drugs IS killing them with the same malice as using a gun.

What is different (and of concern) is the concept of a heinous crime. The worst possible interpretation is these were commercially-motivated executions, designed to show the world that the Chinese are tough and their products getting safer. Even still, six murders were involved in the milk tainting case and one purpose of punishment is deterrence. Whatever we may think about the effectiveness of capital punishment, one hopes that those considering crimes involving fake foods and drugs will think twice (and twice again?) before proceeding in China.

We haven’t sent the same strong message to would-be malefactors in the U.S. and those exporting to the U.S.

Given this, we should be thankful to FDA for every day we don’t encounter willfully adulterated foods and intentionally fake and dangerous drugs and devices. And we should be rethinking whether our own standards are in dire need of upgrading. These are not situations in which probation and forgiveness are the right approaches.


PS: To anticipate and deflect some outraged feedback, this column is specifically about gross negligence where the person knew–or should have known– in advance that someone would be likely to die. Such events occur more often than any of us want to acknowledge.

One Response to “Adulterated Foods/Counterfeit Drugs: Punishment Should Fit the Crime”


    A reader asked me how I felt about the Park Doctrine, which applies to drug companies and sets a standard of strict liability. If you are the responsible officer of a company (e.g. CEO), then you are liable for any problems, REGARDLESS of whether you knew or should have known about them. In contrast, my article specifically addressed situation of negligence and gross negligence, when the individuals involved "knew or should have known" that they were likely to harm someone. 
    Strict liability is an unnaturally tough standard. In real life, it makes a CEO responsible for malfeasance that might have intentionally occurred in a way that he/she could never have known about it. In principle, I am sympathetic to holding food and drug executives to the highest possible standard….but in reality, the Park Doctrine is rarely if ever applied because it draconian and strikes most people as unfair. 
    One small part of what makes it unfair (and the topic of my column) is that we are not even remotely doing a good job prosecuting people who are clearly negligent. Until we do so, I think that the Park Doctrine is more of a hindrance to safe food and drugs than it is an encouragement. When we do a better job getting the truly bad guys, then maybe it is time to assess whether there is justification for a still higher standard. For the moment, my best answer is: probably not. Steven

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