justified, discretionary fortification needs additional scientific study or proceeds on a trial basis while more information is gathered, or discretionary fortification is scientifically justified. If the public health need is sufficient, agencies may consider approaches other than discretionary fortification as a means to increase a nutrient in the food supply, including the use of supplements.

Step One. Determine whether a dietary inadequacy of a specific nutrient has been documented scientifically in at least one segment of the population and if there is sufficient public health need. If no dietary inadequacy of a specific nutrient has been documented scientifically in at least one segment of the population, there is no demonstrated public health need for increased availability of the nutrient, and no discretionary fortification is justified. However, if there is a documented inadequacy and sufficient need, the next step is consideration of the UL.

Step Two. If a UL has not been set by the DRI reports for the nutrient being considered for discretionary fortification because there are no reports of adverse effects,3 then discretionary fortification to address the inadequacy would be scientifically justified. Different approaches might be taken depending upon the language in the DRI reports.

For a number of nutrients no UL was set because there was insufficient documentation of adverse effects and the DRI report language does not include a statement that indicates a concern about safety. For example, “There are no reports available of adverse effects from consumption of excess thiamin by ingestion of food and supplements. Because the data are inadequate for a quantitative risk assessment, no Tolerable Upper Intake Level (UL) can be derived for thiamin” (IOM, 1998, p. 81). For several other nutrients the UL was not set because there was insufficient documentation of adverse effects; however the DRI report language indicated a concern about safety. For example, “No adverse effects have been convincingly associated with excess intake of chromium from food or supplements, but this does not mean that there is no potential for adverse effects resulting from high intakes. Since data on the adverse effects of chromium intake are limited, caution may be warranted”

3  

A UL was not set for the following nutrients for the population 4 years of age and older: vitamin K, thiamin, riboflavin, vitamin B12, pantothenic acid, carotenoids, arsenic, chromium, silicon, and vanadium.



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