The tasks of genetic engineering and the promise of nutraceuticals.
Calgene Inc.'s Flavr Savr[R] tomato, the first genetically-engineered whole food, was designed to offer consumers "summertime taste" all year long. The popular press embraced the concept, as Time Magazine amusingly dubbed the new fruit "Fried Gene Tomatoes". Tomatoes are in the spotlight again due to clinical nutrition trials which have revealed a link between an antioxidant in tomatoes, called lycopene, and a reduced risk of prostate cancer. One can now envisage experimental field trials designed to grow tomatoes which consistently supply the level of lycopene required to achieve effective prophylactic results. Such a goal is by no means new. A fifteenth century philosopher, Paracelsus, is quoted as saying "Everything man needs to maintain good health can be found in nature ... the true task of science is to find these things". With more than 600 antioxidants prevalent in nature and as many human ailments, the true task Paracelsus the philosopher delegated to scientists is indeed a mammoth one.
Paracelsus' "things" have been encapsulated in the term "nutraceutical", coined in 1992 by Stephen DeFelice and broadly defined as "a food or food ingredient considered to provide medical or health benefits, including the prevention and treatment of disease". Claims of this nature, commonly called health claims, are either illegal or subject to strict regulatory approval. However, nutraceuticals have captured the attention of many segments of industrialized society - health-conscious consumers, food manufacturers, food ingredient suppliers, pharmaceutical manufacturers, healthcare professionals, nutrition researchers, academics and regulators.
There are four possible sources of nutraceutical products: 
(1). traditional raw food, e.g. carrots, which contain the autioxidant beta carotene;
(2). processed food without added ingredients (non-fortified) such as oat bran cereal, which contains soluble fibre;
(3). processed food with added ingredients (fortified) such as calcium-enriched orange juice; and
(4). genetically-engineered raw food, such as an enhanced tomato.
Nutraceuticals from the first category are commonly found throughout the supermarket such as wheat bran, oat bran, legumes and spinach - raw foods which have earned recognition as nutraceuticals owing to the clinically-proven ability of each, as part of a balanced diet, to mitigate or modulate the risk of a particular chronic disease. High-fibre cereal, cranberry juice and yogurt are similar examples from the second category. The third category is considered a fortified food and is not generally-available on the open market in Canada, although more prevalent in other industrialized countries.
There are no nutraceuticals specifically derived from genetically-engineered raw food in the marketplace. Despite this, some lay people assume the terms "genetically engineered' and "nutraceutical" are synonymous. The reason for this is not clearly known; however, consumers are hearing of a new food category, nutraceuticals, on the one band and a new food development technique, genetically-engineered food on the other, and, incorrectly connect the two. In most cases, the two spheres are mutually exclusive except for one small area of overlap.
The field trials approved for experimental release in Canada in 1996  listed 936 breeding objectives to be conducted on crops such as corn, canola, soybeans and alfalfa. Of the total objectives, 15 (or 1.6%) were for nutritional change and 12 (1.2%) were for pharmaceutical purposes. Broadening the definition of nutraceutical to include modified oil composition showed 32 (or 3.4%) for this latter objective. Thus, of 936 field trials, between 2.8% and at the very most, depending on definition, 6.2% were conducted for nutraceutical purposes.
While the magnitude of experimental genetic engineering being conducted for the sole purpose of nutraceuticals, commonly called "transgenic nutraceuticals" is indeed small, it is also an extremely intense area of research. Biotechnology has been cited as the workhorse of nutraceuticals , owing to the ability to provide patent protection, market exclusivity, research incentives and consistently adequate levels of an active ingredient. While the rewards look promising, it is currently difficult to measure the practical and profitable contribution of genetic engineering to the nutraceutical revolution. Firstly, consumer research on nutraceuticals has shown that consumers will choose this alternative as an uncomplicated, safe and mild solution to their healthcare needs . Contrastingly, consumer research on biotechnology has shown that some consumers do not regard genetically-engineered organisms as having these attributes.  Thus, genetic engineering could be counterproductive to the aims of the nutraceutical revolution. A recent survey showed that the largest potential consumer acceptance of genetic modification of food is that with a nutraceutical benefit.  Since labelling legislation in Canada and the USA stipulates that a nutritional compositional change triggers the requirement to label the food as genetically-engineered, this may work in favour of a nutraceutical manufacturer. However, it is unknown if the genetic modification would negatively effect other product characteristics. For example, some product development tests show that beta-carotene can impart an "eggy'" flavour, minerals can deliver a "chalky" dry taste, vitamins are not heat stable and dietary fibre requires flavour masking. If drawbacks such as these surface in the genetically-engineered nutraceutical, they must be overcome to secure customer loyalty, regular consumption and patient compliance. Lastly, established nutraceuticals such as oat bran, yogurt and cranberry juice are foods which have enjoyed many years of safe consumption. A genetically-engineered nutraceutical needs to establish safety status both as a food and for its intended use.
Professionals working in the sphere of transgenic nutraceuticals are highly aware of the multiple obstacles ahead of them. Most acknowledge that nutraceuticals must be a significant element of a balanced diet to be physiologically effective and hence, are aware of the health, safety and regulatory aspects associated with the genetically-modified novel food. Despite this, they are motivated by the promise and rewards of easily-consumed, generally available foods which address some of today's healthcare needs. One researcher states "Vegetables represent a terrific medicinal delivery system because everyone is familiar with them as healthy [...] This diverse group of crops offers tremendous potential for developing tailor-made genotypes or varieties that will have enhanced levels of the compounds affiliated with reduced risk of disease."  Many firms devoted to the commercialization of transgenic nutraceuticals appear to have adopted the thoughts embodied in the closing paragraph of a ground-breaking market definition study of the Canadian functional food and nutraceutical community:  "Developing business in this area is not easy, but for those who approach the challenges with the right skills and resources, and who have an integrated approach to development, the commercial potential is considerable." In the meantime, North American men are ordering tomato juice at the lunch counter with increasing frequency!
1. Bulletin. Food and Drink Daily, 'Nutraceutical Food, Drinks in Global Market', 3(503), April 1993.
2. Plant Biotechnology Office, Summary of Experimental Releases, 1996 (Most recent year of full-year information).
3. DeFelice, Stephen L., 'A Recommendation for U.S. Economic and Regulatory Reforms', Genetic Engineering News, 12(5):2-4, April 1992.
4. Wrick, Kathy L.; Friedman, L.; Brewda, J.K. and Carroll, J.J. 'Consumer Viewpoints on "Designer Foods"', Food Technology, March 1993, pp. 94-104.
5. Hoban, Thomas J. and Kendall, Patricia A, 'Consumer Attitudes About Food Biotechnology', USDA, North Carolina State University and Colarado State University Project No. 91EXCA-3-0135.
6. Internet Survey. The Internet Food Channel (http:// www.foodchannel.com).
7. Juvik, Jack. Professor Plant Genetics, University of Illinois at Urbana-Champaign, Functional Foods for Health, 4(4):1012, June 1997.
8. 'Nutraceuticals/Functional Foods An Exploratory Survey of Canada's Potential', International Food Focus Ltd. (http://aceis.agr.ca/misb/nutra/enutra.html).
Carol T. Culhane, PHEc, MBA is the President of International Food Focus Ltd., a strategic marketing and business development consultants, firm which enables organizations in the food and pharmaceutical industries to profitably and confidently market new products and services. Carol is a noted author and popular speaker, as well as a professional member of numerous trade associations, serving as an active member, on the executive or as a volunteer. [C] International Food Focus Ltd., 1997.