Perspectives on Risk and Regulation: The FDA at 100 (review)

This book amounts to an edited proceedings of a conference held on 16 May 2006 celebrating the centennial of the 1906 Food and Drugs Act, the start of modern federal food and drug regulation in the United States. The conference had the mission of looking at the past, present, and future of food, drug, and device regulation. Perspectives on Risk and Regulation contains some valuable historical insights and examples of how analysis of the past helps today’s policy makers address contemporary issues.

The book is divided into four sections of thirteen chapters by different authors, including several prominent FDA (Food and Drug Administration) officials. The first section, “Historical Perspectives” contains an introduction by the editors to the topic and a provocative fifteen-page essay by Peter Barton Hutt on “Turning Points in FDA History.” (Hutt pulls out ten turning points, arguing that “the history of food and drug law is the really the history of science” (14). The second section on “Drug and Medical Device Regulation” holds four chapters plus a transcript of discussion at the conference. The two chapters on drugs are fairly ahistorical, while the two on medical devices remind us of the large changes in that area since incidents in the late 1960s and early 1970s with pacemakers and the Dalkon Shield elicited amendments to the 1938 law. The third section of four essays and discussion session centers on “Food and Dietary Supplements Regulation.” In his piece on food safety, Robert Brackett, director of the FDA Center for Food Safety and Applied Nutrition, does a nice job running through the twentieth century and the changing difficulties regulators faced. The two pieces on dietary supplements contain some useful historical information but concentrate on contemporary concerns, which is understandable considering the confusing status of dietary supplements, “nutraceuticals,” etc. However, this reviewer is distressed by the apparent reluctance of the two authors to address directly the question of quackery and dietary supplements. The FDA staffer on the panel, Barbara Schneeman, director of the Office of Nutritional Products, Labeling, and Dietary Supplements, did not mention the issue at all. It was left, oddly enough, to Steven Mister, head of a trade group of supplement makers, to bring up the problem, which he relegated to “rogues” and those embarrassing hawkers of odd diets and supplements that plague late night television. Section 4 contains the address to the conference by FDA Commissioner Andrew von Eschenbach, where he looks to the future of drugs and foods and their regulation.

Overall, the panelists, split between officers of the FDA and representatives of food and drug manufacturers, have written engaging chapters. The authors are not, however, trained historians. While the resulting volume offers few new historical insights for the journal readers familiar with the general topic, it does provide a window into the thinking of regulators and their counterparts in industry. It shows how they use history in their development of and reaction to the regulation of food, drugs, and medical devices. For that reason, Perspectives on Risk and Regulation may be more useful for scholars and students interested in healthcare policy or public health than history. Future historians, no doubt, will find a great deal to mine from this book on the attitudes of regulators and the regulated in 2006. For that reason alone, it deserves a spot on the shelves of our health sciences libraries.

The book is modestly prepared, with only a few graphs and tables to break up the text. There is no index and only a few useful endnotes. Not to be ignored is an eight-page chronology of important “Milestones in the History of U.S. Food and Drug Law,” which opens the book. It begins in 1862 with the start of the Bureau of Chemistry, unfortunately not including the 1848 Drug Import Act. Modestly priced, the book could be a good supplementary text for a course on food and drug law.