Historically, food fortification programs were often undertaken with little attention to issues such as micronutrient bioavailability, optimal levels of addition, or efficacy or to monitoring impact on nutritional status, health, and human function. Several developments in recent years have enabled substantial progress to be made in the design and evaluation of fortification programs. The methodology for estimating the prevalence of inadequate nutrient intakes in a population and tolerable upper intake levels has been established and can be used as the basis for estimating desirable amounts of nutrient addition. More attention is being paid to assessing the bioavailability of nutrients (especially minerals) using stable and radioactive isotopes, and bioavailability of iron compounds can be estimated from changes in total body iron calculated from the ratio of transferrin receptors to serum ferritin. Procedures for quality control of the fortification process have been established. New approaches to monitoring the impact of fortification over time include assessment of liver retinol stores using retinol isotope dilution. In summary, the design and evaluation of food fortification programs now requires a series of formative research procedures on the part of nutritionists, which were not often expected or conducted in the past.