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China Food And Drug Outsourcing Gets Criminal. Fast.

Posted by Dan on November 17, 2009 at 04:28 AM

My law firm has in the last few months been called in a couple of times to assist other law firms in defending federal criminal actions here in the United States arising from Chinese imports. These two cases are still very much pending so I cannot discuss them in any detail. However, they have taught me a couple things regarding United States criminal law, one of which I found really surprising. Here goes:

This was the big surprise. Federal statute, 21 U.S.C. § 331(a), prohibits “[t]he introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded." This statute is a strict liability statute, which means you can be found guilty of violating it even if you had no intent and no knowledge regarding the crime. In other words, if you import adulterated or misbranded food or drugs into the United States, you can be found criminally liable even if you had no idea of any problems. A violation of this statute is a misdemeanor punishable by up to one year imprisonment, a fine of up to $100,000 ($200,000 for a corporation) and up to one year of supervised release. The penalties can be even higher for a second violations and for violations with “intent to defraud or mislead."

I just thought you should know. Did you?

US criminal lawyers, weigh in please.

Comments

As a current law student, I can't help but think of the Carolene Products doctrine, from the case about "filled milk." But it's pretty amazing that you don't hear of very many prosecutions under this statute, especially in light of recent food scares.

I can assure you that this is something worth paying attention to. I would not want to be an officer with the offending company....should the deal end up in high profile media cycles, one could easily end up the scapegoat in criminal court. Diligence, diligence, diligence.

Forgive my legal ignorance, but how many "strict liability" statutes exist under which you can be convicted of a crime without any intent or knowledge? Does the statute at least require negligence?

I've tried adulterated goods cases, and they are very much criminal cases, even though corporations would prefer to see them as simple errors that occasionally happen despite the best of intentions.

The affirmative duty is to only place into the stream of commerce unadulterated goods, which is why the introduction of adulterated goods is a strict liability offense. But the consequence of intent, raising the offense from a federal misdemeanor to a felony, is very significant. And I've rarely seen a case where the government didn't indict for the intentional offense, with the unintentional misdemeanor available as a lesser included offense.

So this is very much a real crime, and something to take seriously. But, these cases can, and have, been won.

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China Food And Drug Outsourcing Gets Criminal. Fast.: