Special Labeling Requirements for Genetically Engineered Food: How Sound Are the Analytical Frameworks Used by FDA and Food Producers?

November 1999

Issue: 54 Food and Drug Law Journal 667-688 (1999).

Despite the benefits genetically engineered food may offer, many consumers would rather leave it off their tables. This, however, is nearly impossible to do in the United States, because the Food and Drug Administration (FDA) generally does not require biotechnology food producers to place special labels on their products, and producers do not do so voluntarily. Both FDA and producers base their positions on analyses that contain weaknesses. FDA's evaluation of the labeling issue is deficient in three ways. First, the agency arguably erred in interpreting the misbranding provision of the Federal Food, Drug, and Cosmetic Act. Second, FDA's analysis is inconsistent with its analyses of similar issues that involve disclosing information to consumers. Third, FDA failed to consider international issues, even though other countries are affected by the U.S. labeling policy. Although biotechnology food producers approach the labeling issue differently, their analysis is deficient in three ways as well. First, producers argue that special labels will scare consumers away from their products, but producers overestimate the difficulties of combating consumer backlash. Second, producers claim that labeling should not be required because it will result in special labels on all food, when in fact, a reasonable line can be drawn to determine which food should bear a special label. Third, producers fear that labeling will introduce burdensome costs, but in reality, a large portion of these costs would be incurred even in the absence of labeling. In short, although both FDA and biotechnology food producers raise important and insightful issues in their evaluations of the food labeling debate, their analyses are not as sound as they first


FDLI's policy regarding the Food and Drug Law Journal online is: Only the Table of Contents and article abstracts for each issue will be posted to our website. Those visitors wishing to obtain a full text version of a particular article, or a copy of an entire issue, may contact FDLI’s Customer Service Department by e-mail at service@fdli.org. Your purchase will be processed quickly, and at reasonable rates.

Any questions or concerns regarding this policy should be directed to Michael Levin-Epstein,
FDLI's Editor-in-Chief.