Food and Drug Law
FOOD AND DRUG LAW - SPRING 2010
Food and drug law is a huge subject, comprising at minimum the areas regulated by the US Food and Drug Administration: food (including dietary supplements), drugs, cosmetics, medical devices, and, as of 2009, tobacco products. In addition, the US Department of Agriculture has regulatory authority over animal products, the Federal Trade Commission regulates food and some drug advertising, and other agencies, particularly on the state and local level, also have regulatory power in this area. We will focus our attention in this course primarily on the Federal Food, Drug, and Cosmetic Act. That law could fit into a small pamphlet when I began law practice; it is now hundreds of pages long (the 2009 tobacco law alone added about 80 pages). In addition it is safe to say that there are thousands of pages of regulations, guidance documents, and other important materials that practicing lawyers need to know about. There is more than enough to keep us busy for a semester.
Our class materials will include multiple chapters from the text Food and Drug Law and Regulation, that was created by the Food and Drug Law Institute for attorneys (http://portal.fdli.org/Purchase/ProductDetail.aspx?Product_code=007c4bdb-95aa-dd11-9ee3-001143349902), available to us by a site license that allowed me to make copies of these chapters available. I have also had printed 95 pages from the Food, Drug, and Cosmetic Act, and will make .pdf and Word versions of those pages available as well, to enable searches. Supplemental edited cases and other materials, along with a course syllabus that will be updated regularly, via a Lexis Web Course for which all students should register (at www.lexisnexis.com/lawschool).
In addition to the traditional final examination, there will be a requirement of a project to be done in pairs or groups of 3, in which the group will pick a subject of interest to explore, learn about, and then teach to the class at the end of the semester. The group projects will comprise 15 percent of the course grade.
If you have any questions, please get in touch -- either by email (cohenm), phone (x4676), or dropping by my office (Rm. 358, 200McA.). I post my office hours for each week on my bulletin board). I look forward to exploring this fascinating (and very large) "corner" of the law with you.
Marsha Cohen