Regulatory Aspects

H H Butchko, Exponent, Inc., Wood Dale, IL, USA

B J Petersen, Exponent, Inc., Washington DC, USA

© 2005 Elsevier Ltd. All rights reserved.

Although there is no universally accepted definition of functional food, the International Life Sciences Institute of North America (ILSI NA) defines such foods as those that provide a health benefit beyond basic nutrition through the presence of physiologically active food components. Health Canada considers functional food as ''similar in appearance to a conventional food, consumed as part of the usual diet, with demonstrated physiological benefits, and/

or to reduce the risk of chronic disease beyond basic nutritional functions.'' The Institute of Medicine of the US National Academy of Sciences has a more limited definition of functional foods as those in which the concentrations of one or more ingredients have been manipulated or modified to enhance their contribution to a healthful diet.

Under a broad definition, functional foods may include conventional foods; fortified, enriched, or enhanced foods; and dietary supplements because they provide essential nutrients often beyond quantities necessary for normal maintenance, growth, and development and/or other biologically active components that impart health benefits or desirable physiological effects. Thus, fruits and vegetables, such as broccoli, carrots, and tomatoes, are the simplest forms of functional foods because they provide physiologically active components such as sulforaphane, ^-carotene, and lyco-pene, respectively.

Although functional foods can play a key role in promoting a healthier population, the government regulation of such foods is important to ensure protection of consumers from fraud and to ensure that any claims provide accurate information, are not misleading, and are scientifically valid. Governments have developed or are developing regulatory frameworks of nutrition and health claims to assist consumers in choosing foods for health promotion. The regulation of functional foods, the types and wording of claims communicated to consumers, and their place in national regulatory frameworks is evolving globally.

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