sample (collected and analyzed in accordance with regulations) is not at least equal to the value declared on the label. This requirement differs from that for Class II nutrients, which are those that naturally occur (i.e., are indigenous) in food. The nutrient content of a composite sample containing a Class II nutrient must be equal to at least 80 percent of the value declared on the label.

In order to ensure compliance with label declarations, fortified nutrients are often added in excess (an overage). The amount of overage to ensure compliance depends on several factors, including the chemical stability of the nutrient itself, the manufacturing process (e.g., where in the process a vitamin or mineral is added; how well the vitamin or mineral is incorporated into the product; the conditions of time, temperature, pressure, and moisture), and the conditions used to simulate abusive handling throughout the distribution and retail chain (because manufacturers cannot control conditions after a product leaves their factories and distribution centers). In the United States reasonable excesses of vitamins and minerals over labeled amounts are acceptable within current good manufacturing practices.

In attempting to comply with the regulation for Class I nutrients, some manufacturing practices may result in unnecessary, excessive overages. Excessive overages would be of concern for those nutrients with a low margin between the DV and the lowest UL and for which a serious adverse effect is the basis for the UL. Even in the absence of the potential for an adverse effect, excessive overages, which may not be captured in food composition databases, complicate the evaluations of nutrient intakes and nutritional status.

Positive Health Message and Public Health Benefit in Nutrition Labeling

The tone of the message conveyed by the elements in the Nutrition Facts box merits careful consideration because the box serves as an important public health communication tool. When the Nutrition Facts box is revised, the committee suggests that thought be given to the selection, organization, and display of nutrients as these elements may impact the tone of the public health message. The Nutrition Facts box currently can be construed as presenting a negative message because many of the required nutrients that appear in bold print on the top of the Nutrition Facts box (e.g., cholesterol, fat, and sodium) are those that consumers are expected to restrict in order to reduce their risk of chronic disease. There is no similar

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