Regulatory Sciences Institute

By definition, a nutraceutical (derived from the term nutritional pharmaceutical ) is a foodstuff (fortified food or dietary supplement) that is held to provide health or medical benefits in addition to its basic nutritional value [1], Nutraceuticals derived from botanicals deliver a concentrated form of presumed bioactive agents from plants that are not generally part of the food supply. The term nutraceutical has no regulatory definition. Similarly, functional foods, as defined by the International Life Sciences Institute (ILSI), are foods that by virtue of physiologically active food components, provide health benefits beyond basic nutrition [2], For the purposes of this review, these two terms will be differentiated by the form in which they are consumed. Nutraceuticals refers to dietary supplements most often found in pill or capsule form functional foods are ingested as part of a normal food pattern. Both are intended to provide beneficial effects beyond their nutritional value, and contribute to an improved state of health and/or reduction of risk of disease. 

SCF opinion on the scientific basis of the concept (requested by the EU Commission), published on 8 March 1996, found it a sound concept, but requested an up-to-date review covering more end-points than carcinogenicity, and possibly two Thresholds (non-genotoxic and genotoxic substances). It also noted that the FDA risk assessment process is different from Europe. APME formed a Task Force with the chemicals industry body CEFIC-FCA in 1995 to evaluate a regulatory concept. ILSI (the International Life Science Institute) formed a Task Force on Threshold of Toxicity in 1996. 

Toxicology of Pesticides Experimental. Clinical and Regulatory Perspectiyes Costa, L. B. Galli, C. L. Murphy, S. D., Eds. NATO Adyanced Science Institutes Series H Cell Biology, Vol. 3 Springer-Verlag New York, 1987. 

The Japanese regulatory authority is the Ministry of Health and Welfare (MHW) and the Pharmaceutical and Medical Safety Bureau (PSMB) is responsible for the promulgation of national and international guidelines in the form of Notifications. Guidelines are available on the Internet web-site of the National Institute of Health and Science (http //www.nihs.go.jp). The MHW has not issued specific guidance on the development of chiral drugs, but has nonetheless responded to the enantiomer-versus-racemate scientific debate. The attitude of the MHW and its advisory body, the Central Pharmaceutical Affairs Council (CPAC) is discussed in two articles by Shindo and Caldwell published in 1991 and 1995 [17, 18]. The latter paper analyzes the results of a survey of the Japanese pharmaceutical industry which sought responses on chirality issues. 

By the way, the committee rejected the suggestion that risk assessment activities be institutionally separated from the risk management activities of regulatory agencies. It recognized the potential problem of the distortion of science, but proposed other, less drastic means to minimize that problem. The committee s thinking on this important matter will emerge in the later chapters of the book. 

Clearly this type of comparison will be affected by international differences other than regulatory ones—in particular, the different states of sophistication of pharmacological and pharmaceutical science and technology between countries, and the state of development and prominence of the industry in different countries economies. Nevertheless, although communication channels from the U.S. National Institutes of Health to U.S. firms are potentially shorter, basic knowledge is an international commodity. Substantial information can therefore be obtained from international comparisons, as in the case of the international comparison between the U.S. and Britain for the period 1962-1971 performed by one of the authors.(20, 21, 22)... 

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