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Overview of the toxicological issues in evaluating the safety of ingredients including limitations of traditional approaches for ingredients that are a large percenteage of the diet and preclinical testing procedures. Considerations when the chemical composition is variable |
J. F. BORZELLECA, VCU, Smith Bldg., Rm. 660, 12th & Clay Streets, Richmond, VA 23298 The proper safety assessment of nutraceuticals and novel foods involves several non-conventional approaches to human studies as soon as the animal data permit, comparative biodispositional (absorption, disruption, metabolism, excretion) studies, nutritional effects and post-marketing surveillance. Efficacy studies in humans can be used to support safety if objective measurements of toxicity are made; these include hematology and clinical chemistry. Anticipated exposure, effects on dietary patterns of consumption and effects on potentially heavy consumers and sensitive segments of the population are also evaluated in the risk assessment process.
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