Safety evaluation of functional ingredients.

Functional ingredients are a diverse group of compounds that are intended to produce a positive effect on the health of the consumer. The term "functional" is not meant to differentiate these ingredients from other ingredients historically consumed as part of the food supply that are indeed biologically active constituents, for example, nutrients. Indeed, all foods should be considered "functional". The term functional ingredient is meant to convey the function of these new ingredients, which is to produce a positive health outcome via physiological activity in the body. Functional ingredients encompass elements of drugs, nutrients and food additives. A framework for evaluation of the safety of functional ingredients utilizes an understanding of both the current regulatory frameworks in place as well as the characteristics that define these particular ingredients. The types of studies conducted and the data generated to support safety of functional ingredients is product-specific and can include compositional analysis, structure/toxicity analysis, evaluation of historical and intended exposure, animal studies, clinical/epidemiologic studies, and evaluation of special considerations such as potential for adverse food or drug interactions.