Confirmation of safety and efficacy at intended use levels

This really is the sine qua non of any new ingredient. It might be tempting to conclude that an ingredient is safe based on a prior history of human exposure. However, unless the historical dose and consumption patterns equate to the proposed use conditions, and unless the effects of the ingredient on specific individuals and population groups have been determined, it would be easy to miss possible adverse reactions. Nor is it acceptable to increase the dose beyond what is realistic simply in order to achieve a positive result. Evaluation of safety includes structure and exposure assessment as well as chemical characterization. Genetic toxicology, animal, metabolism and human studies all contribute to the assessment.

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