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 on the web.
In the types of materials referenced in this text, most of the broken Internet addresses result from reorganization of large document repositories. If search engines cannot find a particular document—and you believe it contains vital information—you may be able to find the document using Internet archives.1
CITATION FORMAT
Citations in this text generally follow The Bluebook: A Uniform System of Citation (20th Ed.). However, some conventions are modified to save space and repetition.
I hope you find this text offers an appetizing menu for understanding food regulation in the United States.
ACKNOWLEDGMENTS
It is impossible to write a text of this nature without owing many people a debt of gratitude. I cannot begin to list you all, but extend a thank you to everyone who furthered my scholarship on food law. I also wish to acknowledge my wife, Kathy, and daughter, Helen, who supported me through the many months of writing, without which this book would never have been finished.
The following publishers, journals, and authors are thanked for their generosity in granting permission for me to publish excerpts from the following publications:
Food and Drug Law Institute: Neal Fortin, The Hang‐Up with HACCP: The Resistance to Translating Science into Food Safety Law, 58 FOOD AND DRUG L J 565–594 (2003).
Food Safety News: Richard Raymond and John Munsel, Is AMI’s Hodges Slinging Mud in the Name of Science? FOOD SAFETY NEWS (Feb. 24, 2012).
International Food Information Council: FDA/IFIC, Food Additives (1992).
Journal of Food Law and Policy: Neal D. Fortin, Is a Picture Worth More Than 1,000 Words? 1 J. FOOD L. & POL’Y 239–268 (Fall 2005).
Thompson‐West: James T. O’Reilly, FOOD AND DRUG ADMINISTRATION, 2d Ed. (2004).
NOTE
1 1 For example, the Wayback Machine, which contains 462 billion web pages archived from 1996, http://www.archive.org/web/web.php (last visited Jan. 22, 2016).
ACKNOWLEDGMENTS
It is impossible to write a text of this nature without owing many people a debt of gratitude. I cannot begin to list you all but extend a thank you to everyone who furthered my scholarship on food law. I also wish to acknowledge my wife, Kathy, and daughter, Helen, who supported me through the many months of writing, without which this book would never have been finished.
The following publishers, journals, and authors are thanked for their generosity in granting permission for me to publish excerpts from the following publications:
Food and Drug Law Institute: Neal Fortin, The Hang‐Up with HACCP: The Resistance to Translating Science into Food Safety Law, 58 FOOD AND DRUG LAW JOURNAL 565–594 (2003).
Food Safety News: Richard Raymond and John Munsel, Is AMI’s Hodges Slinging Mud in the Name of Science? FOOD SAFETY NEWS (Feb. 24, 2012).
International Food Information Council: FDA/IFIC, Food Additives (1992).
Journal of Food Law and Policy: Neal Fortin, Is a Picture Worth More than 1,000 Words? 1 JOURNAL OF FOOD LAW AND POLICY 239–268 (Fall 2005).
Thompson‐West: James T. O’Reilly, FOOD AND DRUG ADMINISTRATION, 2d Ed. (2004).