Front of Package Labeling (FOP)
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1 Show/Hide More Development Original Creator: jgersen -
2 Show/Hide More Smart Choices Program Original Creator: jgersen -
3 Show/Hide More FDA FOP Labeling Initiative Original Creator: jgersen -
4 Show/Hide More New Industry Initiatives: Nutrition Keys Original Creator: jgersen -
5 Show/Hide More Moving Forward Original Creator: jgersen -
6 Show/Hide More Misbranding Original Creator: jgersenRecall that the two major federal statutes pertaining to food and drugs in the first half of the twentieth century were the 1906 Pure Food and Drug Act (PFDA) and the 1938 Food, Drug, and Cosmetic Act (FDCA). Although the 1938 statute attempted to fix many of the earlier law's failings, many legal requirements and doctrinal frameworks carried over from the PFDA to the FDCA.
The PFDA made it illegal to manufacture or transport any food that is “misbranded.” Pure Food and Drug Act of 1906, sections 1-2, 34 Stat.. 768, 768-72 (repealed 1938). The purpose of the PFDA's misbranding provision was “to make it possible that the consumer should know that an article purchased was what it purported to be; that it might be bought for what it really was, and not under misrepresentations and to character and quality.” United States v. Johnson, 221 U.S. 488, 497 (1911).
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6.1 Show/Hide More United States v. Johnson Original Creator: jgersenAlthough United States v. Johnson is a case about the meaning of misbranding for drugs, the same analysis applies to misbranding of foods. Note also the close relation and even overlap between the treatment of food and drugs in the cases implementing the statute.
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6.2 Show/Hide More Hall-Baker Grain Co. v. United States Original Creator: jgersen- Criminal Intent. The charges brought against Hall-Baker Grain Co. were criminal charges. At issue in this case is what level of intent on the part of the defendants must the government establish at trial in order to sustain a conviction. Although ours is not a class in criminal law, a brief discussion may be useful. For most crimes, a criminal conviction requires establishing actus rea and mens mea, a guilty act and a guilty mind. In the main, the government must show that a defendant had the necessary intent, the right mens rea. Different crimes require different levels of intent, but there are five typical possibilities: (1) Purpose—the defendant had a purpose to bring about the harm; (2) Knowledge—the defendant knew to a substantial certainty that an act would result in the harm; (3) Reckless—the defendant was aware of a substantial risk that harm would result form the act, but did so anyway; (4) Negligence—the defendant knew or should have known that there was a risk of harm and did not avoid it. Other crimes are known as strict liability crimes, for which no showing of intent or mens rea is required. Particularly early in the evolution of food and drug law, some crimes involving food or drugs were initially treated as strict liability crimes. The question for the Eight Circuit was thus, whether misbranding and adulteration under the PFDA were to be treated as ordinary or strict liability crimes.
- Chain of Custody. Hall-Baker Grain presents a very common shipping scenario. Goods are stored in one location, ordered from a buyer from a shipper, who notifies the storage facility, who packs and then ships the goods. Along the way, there are many opportunities for fraud of various sorts. Lower quality goods can be mixed with higher quality goods. Volume can be manipulated such that a buyer receives less of a high quality good than expected. High quality goods can be replaced by low quality goods by a shipper or a middleman. And so on and so on. Note that the grain industry had a particular way of managing such problems, partially involving government inspectors at the point of shipment and receipt. Why is the market unable to solve this basic problem of fraud and verification?
- Least Cost Avoider. A standard concept in law and economics is the least cost avoider (or cheapest cost avoider). The least cost avoider is the person or actor who can most easily avoid a harm. One prominent theory is that the law should impose liability on the least cost avoider precisely because they are best situated to avoid a harm. Who is the least cost avoider in this case and does decision of the Eight Circuit impose liability on them?
- Civil v. Criminal. Not that the same rule may not apply to civil and criminal settings. Even if there is no criminal liability for the company because there was not mens rea demonstrated, it may still be that there is civil liability for the delivery of misbranded goods. After all, the buyer paid for one thing and received another thing of lesser value. Does the decision make misbranding more or less likely then? Are you confident?
Notes:
1. Just a trial note to check location. -
6.3 Show/Hide More V.E. Irons, Inc. v. United States Original Creator: jgersen
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6.4 Show/Hide More Consumer Expectations Original Creator: jgersen -
6.5 Show/Hide More United States v. Strauss Original Creator: jgersen
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6.6 Show/Hide More Consumer Expectations Original Creator: jgersen -
6.7 Show/Hide More United States v. Strauss Original Creator: jgersen
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6.8 Show/Hide More Consumer Expectations Original Creator: jgersen
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February 11, 2016
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jgersen
Jacob Gersen
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