The above-described scenario gave new conditions that were followed by the appearance of new definitions for the relationship between foods and medicine:12
• Nutraceutical. Any substance that may be considered a food or part of a food and provides medical or health benefits, including the prevention and treatment of disease.
• Functional food. Any modified food or food ingredient that may provide a health benefit beyond the traditional nutrients it contains.
• Pharmfood or medical food. A food or nutrient that claims medical or health benefits, including the prevention and treatment of disease.
Unfortunately, these definitions are not universally accepted; they vary from country to country and clearly are still evolving. The nutraceutical term does not exist under U.S. legislation, whereas functional foods defined as "Foods for Specific Health Use" or FOSHUs are legal entities in Japan.12 FOSHUs are processed foods containing ingredients that aid specific bodily functions in addition to nutrition, and they include 11 categories: (1) dietary fiber; (2) oligosaccharides; (3) sugar alcohols; (4) polyunsaturated fatty acids; (5) peptides and proteins; (6) glycosides, isoprenoids, and vitamins; (7) alcohols and phenols; (8) cholines; (9) lactic acid bacteria; (10) minerals; and (11) others. FOSHUs are evaluated by the Ministry of Health and Welfare to grant permission to indicate the nature of effectiveness to the health.6
On the other hand, and according to the Institute of Medicine, U.S. National Academy of Sciences, "functional foods are ones in which concentrations of one or more ingredients have been manipulated to enhance their contributions to a healthful diet." It is clear that these definitions are not synonymous although several authors use them interchangeably. In the United States, functional food terms are used to encompass designer foods, pharmfoods, and other related nomenclature. Thus, functional food ingredients range from traditional vitamins and minerals to herbs and other phytochemicals. However, a distinction has been established between fortified foods and functional foods. Fortified foods are primarily used to help prevent nutritional deficiency; the broader category of functional foods goes beyond nutrition, helping to prevent or treat disease and advance the overall health of an individual. In fact, under this distinction, fortified foods are actually a type of functional food. Under U.S. legislation medical foods require previous evaluation to permit health claims; additionally, a medical doctor must prescribe medical foods.
On the other hand, nutraceuticals and functional foods have been presented as "generally recognized as safe" (GRAS) substances and they are commercialized over-the-counter. After the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994, the definition of nutraceuticals has been expanded to include vitamins, minerals, herbs and other botanicals, amino acids, and any dietary substance for use by humans to supplement the diet by increasing total dietary intake. To comply with the regulations, a nutraceutical must be labeled as a dietary supplement and shall not be represented for use as a conventional food or as a sole item of a meal or diet.13 As examples, dietary fibers stimulate the activity of the bacteria already in the colon; inulin, oligofructose, and Psylium are dietary fibers that can reduce the risk of some chronic diseases by lowering blood triglyceride levels, increasing high-density lipoprotein (good cholesterol), increasing stool weight and frequency, controlling blood glucose, and possibly preventing colon cancer, in addition to stimulating bifidobacteria. Thus, the functional food trend is moving more quickly than federal regulation.14 At present, pharmaceutical companies have changed their strategies and instead of developing drugs they are looking for nutra-ceutical/functional foods: a drug requires around 10 years to be approved by the FDA; in addition, it costs $250 million in the process. On the other hand, nutraceuticals can be approved in less than 3 years at a considerably lower cost. Different products have been introduced claiming nutraceutical properties: Monsanto produces soybean oil with higher levels of estearate and laureate and alga oil (SeaGold), which are commercialized by virtue of their contents of omega-3.15
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