Functional Foods


Since the earliest days of agricultural biotechnology development, scientists have envisioned harnessing the power of genetic engineering to enhance nutritional and other properties of foods for consumer benefit. The first generation of agricultural biotechnology products to be commercialized, however, were more geared towards so-called input traits, genetic modifications that make insect, virus and weed control easier or more efficient. These first products have been rapidly adopted by U.S. farmers, and now account for the majority of soybeans, cotton and corn grown in the United States.

Agricultural biotechnology innovations aimed directly towards consumers, sometimes collectively referred to as output traits, have been a longer time in development. As the technology advances, and we learn more about the genes and biochemical pathways that control those attributes that could offer more direct consumer benefits, the long-awaited promise of genetically engineered food with more direct consumer benefits moves closer to reality.

One category of potential products aimed at consumers is those products with added health benefits, also known as "functional foods." The term functional food means different things to different people, but generally refers to foods that provide health benefits beyond basic nutrition.

This report looks at the potential to develop functional foods through the application of modern biotechnology. The first section describes some recent scientific advances that could lead to functional foods on grocery store shelves, and the second section analyzes the legal authorities that could govern the use of biotechnology-derived functional foods.

The range of work being done on functional foods described in this report—from oils that product no trans fats or contain heart healthy omega-3 fatty acids, to cassava with increased protein content to help fight malnutrition in developing nations, to foods with enhanced levels of antioxidants—is impressive. This report is not intended to be an exhaustive catalog, however, but is rather a snapshot in time to give readers a sense of the kinds of products that may one day be available.

It should also be noted that much of the work described here is still in preliminary stages, and may never make its way into consumer products for technical, economic or other reasons.

The analysis of relevant statutory authorities suggests that there is ample legal authority to cover the kinds of functional foods currently being explored in laboratories, but that different authorities may come into play for different kinds of foods and that the application of different authorities can have significant consequences for product developers, food manufacturers and consumers. Different authorities impose different safety and labeling standards, have different requirements for regulatory review and clearance or approval, and could result in different levels of transparency to the public. The use of modern biotechnology to produce functional foods will not likely fundamentally challenge existing regulatory structures, but may challenge the boundaries of some regulatory classifications.

The Pew Initiative on Food and Biotechnology's first report, Harvest on the Horizon (2001), provided a broad overview of what could be the "next generation" of genetically engineered agricultural products. It is fitting that this, the last of the Initiative's reports, turns again to look at a category of new products on the horizon.

We would like to acknowledge the contributions of Joyce A. Nettleton, who created the scientific review used in the development of this paper; and of Edward L. Korwek, for the review of regulatory authorities that could govern future functional foods.

Michael Fernandez
Executive Director