FD&C Act regulates all these products, and there are commonalities in the regulatory framework for all. Sometimes a drug or medical device case illustrates a point about food law better than anything directly about food.
A ROAD MAP FOR READING THE MATERIALS IN THIS BOOK
This text presents diverse materials from pertinent sources. The author provides some commentary and context, but you should digest these materials for yourself. This can be especially challenging to the novice because you not only have to understand the materials, but you also have to jump around the various writing styles, understand the context, and discern the relative value and weight of each source. Stay with it, and you will find it soon becomes easier.
In keeping with the way information is encountered in practice, not all materials in this text are equal. Some may be read quickly. Others will require close scrutiny. Moreover, materials will be presented in varying levels of formality. When possible, the materials are condensed to be easier for you to read.
If you are new to this teaching style, it may be disconcerting at first. Please do not let this throw you. Persist and trust your instincts. You will find that your effort pays dividends quickly. In the end, you will learn much more than the rules but develop and hone critical skills for regulatory analysis. These skills are not only vital in legal analysis but are also extremely useful in winnowing through the mountains of information available on the Internet. In addition, law and regulation are not static subjects, so developing these dynamic skills will be beneficial in the end.
Here are a few tips to those of you who are new to this teaching method:
Review your road map of each chapter—review the chapter title, the other headings, and the table of contents before reading. These will provide you with an overview of how the chapter material relates to the overall text.
Put the material in context. Note the source of the material quoted. Who wrote the material will tell you what type of perspective is offered. Often, regulations reconcile conflicting interests; and understanding both sides can be key to a complete picture. Note the date when the material was written, which may indicate that the material is provided for historical perspective, or that part of the information may be pertinent, but part may be outdated.
In reading the cases, develop the ability to understand how the court reasoned through the conflict to a solution. Identify the particular factors used by the court to decide the case the way it did. Check to see if those factors are present in a problem with which you are dealing. If the factors are not present, then ask yourself if that justifies a different result. If there are any changes in the social or economic conditions that surrounded an earlier decision, ask how that affects the problem now at hand.
In short, learn to analyze the materials, rather than merely read and memorize rules.
EDITING
I have edited out most of the footnotes and citations from the court cases. Remaining footnotes are renumbered with my own footnotes. Unless otherwise indicated, any footnotes within the cases are those of the court. In addition, materials may be edited for typographic style without notation in the text.
STATUTORY RESEARCH USING THE FEDERAL REGISTER, CFRS, AND STATUTES
Food regulation in the United States is primarily based on statutory law. For this reason, it is generally best to read or review the statutory language before reading the cases and secondary materials, which serve mainly to explain statutory issues. When reading the statutes or regulations, be sure that you also review the definitions of defined terms used—particularly the key definitions in section 201 of the FD&C Act, such as “food,” “drug,” “adulterated,” and “misbranded.” In addition, when reading the statutory language, obtain at least a general idea of what is covered by any statutory cross‐references.
A NOTE ON STATUTE CITATIONS
All federal statutes in force in the United States are codified into the United States Code (U.S.C.). This codification is an organization of many statutes into a single code, which allows the U.S.C. to be organized by subject matter. For example, most food laws are organized into Title 21 of the U.S.C.
In the course of this organization of the statutes, necessarily section numbering of the acts must be renumbered. For example, section 1 of the FD&C Act is codified as 21 U.S.C. § 301. Thus, you may find this section cited with one or the other or both reference numbers, such as “Sec. 1 [301].”
Citations to the Food, Drug, and Cosmetic Act (FD&C Act) in this book material are to the statute. I also follow with a parallel citation within the brackets to the U.S.C. number. For example, section 1 of the FD&C Act is codified as 21 USC § 301 (Title 21 of the United States Code section 301); thus, I would cite this section as “FD&C Act Sec. 1. [301]”. Nonetheless, occasionally, you will see reference to a U.S.C. citation alone in some of the court decisions.
Most (but not all) of the U.S.C. citations are created by dropping the middle digit and putting a 3 in the hundred’s digit. Thus, FD&C Act Section 401 is codified as 21 U.S.C. § 341. Single‐digit FD&C Act sections become 30×; for example, FD&C Act Section 1 becomes 21 U.S.C. § 301.
FD&C ACT REFERENCES
Free online locations for reference to the FD&C Act include the following:
Cornell’s LII: www.law.cornell.edu/uscode/text/21/chapter‐9
Office of the Law Revision Counsel: http://uscode.house.gov
U.S. Government Printing Office (GPO) Access: www.gpo.gov/fdsys/browse/collectionUScode.action?collectionCode=USCODE
Of course, Westlaw and Lexis‐Nexis provide access to the most up‐to‐date text of the FD&C Act.
DISCUSSION QUESTIONS
The discussion questions within the chapters are designed to encourage thought on the material presented or for class discussion. Some of the questions have neither a right nor wrong answer, particularly those questions that have multiple viewpoints on public policy issues.
PROBLEM EXERCISES
The Problem Exercises are designed to encourage critical thinking. They take on a variety of forms but some are designed to provide practice answering essay questions in food law.
INTERNET CITATIONS
The fluid nature of Internet addresses creates difficulty for a textbook of this nature. The food regulation information available on the Internet is far too valuable not to include some Internet addresses. Inevitably, however, some of these addresses will have changed or the documents will have been removed within days of this book’s printing.
Please realize that learning what types of materials are available is more valuable than finding a specific document. When you find a broken Internet address, take the opportunity to use search engines to find the new location, or to find similar material
