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55 Food & Drug L.J. 301 (2000)
Biotechnology and the Food Label: A Legal Perspective

handle is hein.journals/foodlj55 and id is 327 raw text is: Biotechnology and the Food Label: A Legal Perspective FRED H. DEGNAN * I. INTRODUCTION Consider the food label. It defies simple classification. It comes in numerous sizes and shapes, from cereal boxes to chewing gum wrappers, from cylindrical cans to fanciful plastic bottles. It bears a variety of messages delivered in a variety of ways and styles designed to attract the consumer's attention. It advertises and promotes. It shares recipes and dietary guidance. It communicates public service announcements and disseminates pictures of missing children. It displays garish likenesses of cartoon characters or exquisite portraits of professional athletes and idols. In short, it is the front line of product marketing and, thus, subject to fundamental yet idiosyncratic decisions as to what information, art work, form, and level of taste will attract con- sumer attention and induce a purchase. Precisely because the food label inspires and provides the critical stimulus for a food purchase, for nearly 100 years federal law has recognized the U.S. government's interest in ensuring that the food label aids consumers in making wise food selections. The precedent derived from this near-century of federal regulation sets the stage for a focused consideration of the issues involving the use of the food label to inform con- sumers about whether food is the product of biotechnology or contains ingredients that are produced through biotechnology. No current labeling issue is more controversial. Part of the controversy derives from a lack of public trust about the short-term and long-term safety of applying innovative genetic engineering techniques to the production of food. Clearly, at work here is the unease felt by many about the use of gene technology in foods-the use of technology in a context that touches our lives daily and personally. Headlines about gene therapy investigations gone awry and the cloning of one large animal species after another serve only to fuel this concern. Nevertheless, the Food and Drug Administration (FDA) has resisted the urgings of interested domestic and foreign parties alike to require, on a whole-scale basis, information on the food label about the ingredients it bears or the genetically-engi- neered status of a food. This position has been founded on FDA's science-based con- clusion that there is nothing inherently unsafe or mysterious about food biotechnol- ogy. Discontent with FDA's scientific conclusion and labeling position has become commonplace. This article focuses on the legal rationality of FDA's current labeling policies in light of its decades of precedent, experience in policing the food label, and use of its statutory authority to require information to appear on the label. II. REQUIRING INFORMATION TO APPEAR ON THE FOOD LABEL A. Five Essential Pieces of Information For purposes of this analysis, the critical root word is require. FDA's funda- mental food labeling authority is found in section 403 of the Federal Food, Drug, and * Mr. Degnan is a Partner in the law firm of King & Spalding, Washington, D.C., and a Distinguished Lecturer at the Columbus School of Law, The Catholic University of America. This article is an updated version of remarks presented at a Gershoff Symposium, Tufts University, Boston, MA (Oct. 29, 1999), and incorporates part of an earlier publication, The Food Label and the Right to Know, 52 FOOD & DRUG L.J. 49 (1997).

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