What types of safety concerns should be factored into FDAs decision-making?
Government standards and guidelines should help prevent excessive nutrient intakes from fortified foods and dietary supplements. At present there is little regulation to guide the amount of nutrients in highly fortified foods, meal replacements, or oral nutritional supplements. Several resources are available to help address the safety of non-nutrients, which are often included in dietary supplement products and are increasingly being included in food products as well. Clearly, a methodology is needed for determining whether consumption of a nutrient does or does not put the public, especially sub-groups deemed to be at high risk such as children, pregnant women, the elderly and the immunocompromised, in danger. Side effects should be evaluated, particularly unusual side effects not normally reported but with serious consequences just the same. The product should not have serious side effects. Furthermore, a modeling methodology needs to be established to account for actual consumer be
