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INFOMATEK Volume 5 Nomor 1 Maret 2003 FUNCTIONAL FOOD Dr. Wisnu Cahyadi, Ir., MSi Department Food Technology Faculty of Technique-Pasundan University Abstract : It is the position of the American Dietetic Association that functional foods, including whole foods and fortified, enriched, or enhanced foods, have a potentially beneficial effect on health when consumed as part of a varied diet on a regular basis, at effective levels. The Association supports research to define further the health benefits and risks of individual functional foods and their physiologically active components. Dietetics professionals will continue to work with the food industry, the government, the scientific community, and the media to ensure that the public has accurate information regarding this emerging area of food and nutrition science. Knowledge of the role of physiologically active food components, from both phytochemicals and zoochemicals, has changed the role of diet in health. Functional foods have evolved as food and nutrition science has advanced beyond the treatment of deficiency syndromes to reduction of disease risk. This position reviews the definition of functional foods, their regulation, and the scientific evidence supporting this emerging area of food and nutrition. Foods can no longer be evaluated only in terms of macronutrient and micronutrient content alone. Analyzing the content of other physiologically active components and evaluating their role in health promotion will be necessary. The availability of health-promoting functional foods in the US diet has the potential to help ensure a healthier population. However, each functional food should be evaluated on the basis of scientific evidence to ensure appropriate integration into a varied diet. Key word : Fuctional foods, food and nutrion, regulation I. INTRODUCTION Expanding knowledge Although functional foods remain undefined of the role of under current US food regulations, they are physiologically active food components, from usually both animal healthful food or food ingredient that may (zoochemicals) sources, has notably changed provide a health benefit beyond the traditional the role of diet in health. The development of nutrients it contains “functional foods” has evolved as food and implies that the food has some identified value nutrition science has advanced beyond the leading to health benefits, including reduced risk (1). for disease, for the person consuming it. plant (phytochemicals) and treatment of primary deficiency syndromes understood to (2). be any potentially The term “functional” Infomatek Volume 5 Nomor 1 Maret 2003 : 57 - 64 Regardless, leaders in the field agree that, consumers regarding how to most appropriately despite the absence of a consensus definition, integrate functional food products into an overall functional foods will continue to have a major varied and healthful eating plan. impact on the American and international food supply (3,4). A random telephone survey of US II. DEFINING FUNCTIONAL FOODS consumers conducted for the American Dietetic There is no universally accepted definition of Association a functional foods; however, several organizations are have attempted to define this emerging food interested in diet and its potential role in category. The International Food Information improving health. In fact, about 50% identified Council (IFIC) defines functional foods as foods functional foods such as soy and berries as that provide health benefits beyond basic having “health-related effects” nutrition significant supported the percentage of notion that consumers (5). In addition, the (2). This definition is similar to that of the International Food Information Council March International Life Sciences Institute of North 2002 survey reported that 94% of consumers America (ILSI), which has defined functional agree that certain foods have health benefits foods as foods that, by virtue of physiologically that go beyond basic nutrition, and 85% of active food components, provide health benefits survey beyond basic nutrition participants expressed interest learning more about functional foods in (6). defines functional (9). foods Health Canada as “similar in appearance to a conventional food, consumed As the food industry has responded to consumer demand for a more healthful food supply, the variety of functional foods that are currently available to consumers has grown tremendously, and functional foods account for an increasing percentage of all new food products (7). The American Council on Science and Health recently reviewed the scientific evidence for the health-promoting effects of as part of the usual diet, with demonstrated physiological benefits, and/or to reduce the risk of chronic disease beyond basic nutritional functions” (10). The Institute of Medicine of the National Academy of Sciences limits functional foods to those in which the concentrations of one or more ingredients have been manipulated or modified to enhance their contribution to a healthful diet (11). specific functional foods and established a Likert-type scale for classification ranging from According to these definitions, unmodified whole (8). foods such as fruits and vegetables represent Dietetics professionals, with broad training and the simplest form of a functional food. For expertise in foods and nutrition, will be integral example, broccoli, carrots, or tomatoes would be to interpreting the science and then educating considered functional foods because they are very strong evidence to weak evidence 58 Functional Food [Wisnu Cahyadi] rich in such physiologically active components likely that the quantity of enhanced foods will as sulforaphane, beta carotene, and lycopene, expand substantially. Functional foods respectively. Modified foods, including those that viewed as one option available to Americans have been fortified with nutrients or enhanced seeking cost-effective health care and improved with phytochemicals or botanicals, also fall health status, and they will continue to transform within the realm of functional foods. In addition, the American food supply. are food biotechnology will continue to provide new IV. REGULATION OF FUNCTIONAL FOODS venues for functional food development. The Food and Drug Administration’s (FDA) III. RATIONALE involvement with functional foods has expanded Development of functional food products will in recent years; however, the regulation of continue to grow throughout the 21st century as functional foods remains confusing consumer demand for healthful products grows current (16). components can be placed into a number of Factors contributing to this reshaping of the food supply include the following: regulations, existing regulatory functional (16,17) . Under foods categories, or including an aging population; conventional increased health care costs; supplements, medical foods, or foods for special self-efficacy, autonomy in health care, dietary use. These categories fall under the and an awareness Federal Food, Drug and Cosmetic Act (FDCA) and desire to food additives, dietary enhance personal health; of 1938, as amended, and are implemented advancing scientific evidence that diet under regulations from the FDA. The category can used to define a specific functional food or alter disease prevalence and component depends on how the manufacturer progression (14); and foods, most importantly, changes in food selectively positions and markets the product for its intended use and the specific label claim regulation. associated with the food item. Nutrients and nonnutritive food components have also been associated with the prevention The most well established and scientifically and/or treatment of chronic diseases such as sound approach to labeling and marketing a cancer, diabetes, functional food is through the use of FDA- As the data approved health claims delineated by law under supporting the role of diet in health promotion the Nutrition Labeling and Education Act (NLEA) and disease prevention continue to mount, it is of 1990 coronary heart disease, hypertension, and osteoporosis (15). (18). The health claims authorized under 59 Infomatek Volume 5 Nomor 1 Maret 2003 : 57 - 64 the NLEA are statements that describe a components, precise levels of recommended relationship between a food substance and a intake will be established only when adequate disease or other health-related condition (ie, a scientific evidence exists. “risk reduction” relationship). The law mandates that a health claim be authorized in the labeling of FDA-regulated products only if significant scientific agreement among qualified experts exists about the validity of the relationship described in that claim. Under the NLEA, companies petition the FDA to consider new health claims. Thirteen NLEA health claims authorized by the FDA currently exist. Substantial clinical efficacy and documentation are an important part of a company’s petition Many functional foods or food components will require continued in vivo and in vitro research, as well as pharmacokinetic studies, before specific levels can be determined for clinical trial investigations. Once clinical trials have been completed, more specific recommendations can be formulated. In addition, a large percentage of dietary data collected historically provide limited information regarding the exact intake of physiologically active food components because few databases for nonnutritive food components submission to the FDA have been developed (16). Current V. LEVELS OF INTAKE Safe levels of intake must be considered when evaluating functional foods in the context of a healthy diet. For the majority of research studies, the optimal levels of nutrients and other physiologically active components in functional foods have yet to be determined in humans. Animal research has provided some indication of desired intake; however, these data are difficult to extrapolate to human dietary requirements. The Table lists the approximate levels of intake whole foods or select nutrients, phytochemicals, and other food constituents used in the development and marketing of functional foods generally associated with health promotion or disease prevention (22–27). However, for the majority of functional food dietary measurement are somewhat limited in terms of providing evidence for levels of intake of dietary constituents necessary to reduce disease risk. For example, data collection, epidemiologic particularly studies that for rely large on food frequency questionnaires (FFQs), does not include specific data related to herb, spice, condiment, and/or flavoring intake, despite the fact that several physiologically active components have been identified in these foods. Recently, FFQs focused on collecting data for select foods such as teas and citrus (28) have been developed and validated and, thus, will allow for expanded efforts to measure exposure and its relationship to disease prevention. However, a second limitation is that the USDA nutrient/phytochemical 60 tools database has only Functional Food [Wisnu Cahyadi] recently been phytochemicals isoflavones (30), insufficient expanded such as to include carotenoids (29), and flavonoids . It still remains for most nonnutritive Expanding roles for dietetics professionals include the following : food advising consumers on the appropriate intake of functional foods and how best to constituents. achieve dietary intake goals, in the context of a healthful diet, to optimize health and Another issue of importance is that dietary potentially decrease the risk of preventable constituents appear to act synergistically to improve absorption of nutrients physiologically active dietary components or diseases; (22). One example is lycopene in tomatoes and the field; enhancement of its absorption when consumed along with fat (23). healthy population can be altered in the disease. Therefore, a unique evaluation and implementation of research studies that are focused on functional foods and physiologically active education to health care working collaboratively with food and government to develop and enhance regulatory standards for functional foods opportunity to play a vital and central role in the their providing nutrition organizations as well as the that assume such foods are safe and label VI. ROLE AND RESPONSIBILITIES OF THE DIETETICS PROPESSIONAL have future prevention; the specific populations or individual variance. professionals of functional foods in health promotion/disease available scientific information in the context of Dietetics development and policy officials regarding the role of advice regarding approximate levels of intake for to be evaluated on the basis of currently the professionals, the public, the food industry, dietary functional foods and their components will need to functional foods; presence of a disease such as cancer or cardiovascular providing expertise to the food industry related The specific intake levels recommended to reduce the risk of disease in a participating in research in this evolving components. claims are scientifically sound and not misleading; and being a resource for the media as the research evolves and specifically to provide guidance regarding integration of functional foods into a balanced and varied diet. Research findings will need to be translated into practical information knowledgeable for dietetic consumers by professionals. 61 Infomatek Volume 5 Nomor 1 Maret 2003 : 57 - 64 VII. SUMMARY [2] Hasler CM. functional Never before has the focus on the health benefits of food or food components have been [3] uniquely qualified [4] regulation, and communication healthier [5] regarding population. Americans’ Food and Nutrition Attitudes Behaviors—American International Food Information Council. annual Bus J 2003;8:1-9. [6] Hasler CM. Functional foods: Benefits, and challenges—A position paper from the American Council on Science National Academy of Sciences, Institute Thiamin, Riboflavin, Niacin, Vitamin B6, [7] International Life Sciences Institute. America Technical Committee on Food Components for Health Promotion. Crit Insight Media Guide, International Food Washington, DC 1998. Nutr selected scientific criteria. ILSI North 1998. Backgrounder: Functional Foods. 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