SCIENTIFIC JUSTIFICATION AND CRITERIA

GUIDING PRINCIPLE 11. The scientific justification for discretionary fortification of food should be based on documented public health needs, particularly on dietary inadequacy that is determined by assessing the prevalence of nutrient inadequacy in the population. Regulatory agencies should develop criteria for determining when the evidence of dietary inadequacy indicates a documented public health need for the increased availability of nutrients in the food supply.

The committee recommends that discretionary fortification be based on public health need. The committee realizes the importance of fortification and its impact on disease prevention and the potential for problems if there are no policies that govern the fortification levels for nutrients. The fortification policies of the United States (21 C.F.R. 104.20) and the proposed policies of Canada (Health Canada, 1999, 2002) warn of over- or underfortification and the potential for nutrient imbalances that may occur as a result of random and excessive fortification of food.

The committee discussed what defines a “need” that can be met through discretionary fortification. This situation might occur when the nutrient content of the general diet does not meet the needs of all segments of the population or when the need might be less widespread. Within these broad situations of public health need, clearly the promotion of the health of the population can play an important role.

As a first step in identifying whether there is a public health need that might provide scientific justification for discretionary fortification, federal agencies should estimate the level of dietary inadequacy in life stage and gender subgroups of the population for any nutrient of concern. The DRIs can be used to assess the proportion of a group that has a usual intake of a nutrient that is less than the requirement. In addition, the health and nutritional status of groups or individuals need to be assessed through use of biochemical, clinical, and anthropometric indicators (IOM, 2000a). The appropriate method for assessing the prevalence of nutrient inadequacy for groups using the DRIs is presented in Section III of Dietary Reference Intakes: Applications in Dietary Assessment (IOM, 2000a). As discussed in that report, assessment is a two-step process. First, the distribution of usual nutrient intakes in the population from both food and supplements must be estimated using appropriate dietary intake assessment methods to determine actual intakes (i.e., 24-hour dietary intake recalls or food records). Then, by applying standard



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