The role of dietary active compounds in human nutrition is one of the most important areas of investigation with the findings having wide‐ranging implications for consumers, health care providers, regulators, food producers, processors and distributors. Thus, the concept of ‘adequate nutrition’ is beginning to be replaced by ‘optimal nutrition’ with consumer belief increasing at an unprecedented pace.
In the past few years, many bioactive constituents of food have been commercialized in the form of pharmaceutical products (pills, capsules, solutions, gels, liquors, powders, granulates, etc.) that incorporate food extracts or phytochemical‐enriched extracts to which a beneficial physiological function has been directly or indirectly attributed. This range of products cannot be truly classified as “food” or “pharmaceutical”, and a new hybrid term between nutrients and pharmaceuticals, ‘nutraceuticals’, has been coined to designate them.
Functional foods are fortified or enriched during processing and then marketed as providing some benefit to consumers. Sometimes, additional complementary nutrients are added, such as vitamin D to milk or yoghurts containing probiotics for intestinal health. Health Canada defines functional foods as “ordinary food that has components or ingredients added to give it a specific medical or physiological benefit, other than a purely nutritional effect.”
In Japan, all functional foods must meet three established requirements: foods should be (1) present in their naturally occurring form, rather than a capsule, tablet, or powder; (2) consumed in the diet as often as daily; and (3) should regulate a biological process in hopes of preventing or controlling disease.
There is a slight difference between the functional foods and nutraceuticals. When food is being cooked or prepared using "scientific intelligence" with or without knowledge of how or why it is being used, the food is called "functional food". Thus, functional food provides the body with the required amount of vitamins, fats, proteins, carbohydrates, etc. needed for its healthy survival. When functional food aids in the prevention and/or treatment of disease(s) and/or disorder(s) other than anemia, it is called nutraceutical.
Nutraceuticals are foods or food ingredients that provide medical or health benefits. This emerging class of products blurs the line between food and drugs. They do not easily fall into the legal categories of food or drug and often inhabit a grey area between the two. Within European Union (EU) law the legal categorization of a nutraceutical is, in general, made on the basis of its accepted effects on the body.
Thus, if the substance contributes only to the maintenance of healthy tissues and organs it may be considered to be a food ingredient. If, however, it can be shown to have a modifying effect on one or more of the body’s physiological processes, it is likely to be considered to be a medicinal substance. Within European Medicines law a nutraceutical can be defined as a medicine for two reasons:
1) It can used for the prevention, treatment or cure of a condition or disease or
2) It can be administered with a view to restoring, correcting or modifying physiological functions in human beings.
CLASSIFICATION OF NUTRACEUTICALS:
Regarding the promise of nutraceuticals, they should be considered in two ways:
A potential nutraceutical is one that holds a promise of a particular health or medical benefit; such a potential nutraceutical only becomes an established one after there are sufficient clinical data to demonstrate such a benefit.
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