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The regulatory process can adjust the GRAS “conditions of use” based on the available data and would allow foods to contain different levels of sodium based on their nature and the way in which they are typically consumed. The United Kingdom, in developing its voluntary program for the food industry, has based its approach on food categories. The voluntary National Salt Reduction Initiative (NSRI) coordinated by New York City, has based its guidelines on food categories as well.

The committee felt that the development of food categories and establishment of appropriate maximum levels would benefit from the rulemaking process, which includes public deliberation, that FDA would be required to undertake, and therefore did not attempt to make recommendations or undertake simulation efforts on these topics. It is expected that FDA would model the dynamics of how different levels of sodium reduction in various product categories would influence population intakes. This information, combined with input from public deliberations on the feasibility of such reductions would factor into the FDA’s development of appropriate food categories and maximum usage levels.

Panel A of Figure 10-1 shows a hypothetical example of a product category with a salt content range of 0–100 mg. This maximum level of salt—shown in the figure as 50 mg and labeled “Maximum Level for GRAS Status”—would allow persons to consume such a food from this category in typical fashion as part of a normal diet and yet keep their total daily intake of sodium at recommended levels given all other foods commonly consumed (each with its own category standards for salt content). Foods within this category with amounts at or below 50 mg per serving would be marketable and those above would not.

However, as discussed in Chapter 8, the implementation of the standards is most likely to be successful if a gradual, stepwise approach is used. Panel B in the figure illustrates the stepwise implementation approach relative to this particular example. Given the range of levels in the hypothetical food product category, it is determined that a hypothetical starting point of 80 mg per serving is consistent with an acceptable and non-disruptive reduction from existing current levels because in this example, across the possible range of salt content per serving, most marketed products do not contain 100 mg per serving (the high amount), thus acceptable reductions could begin at 80 mg per serving. The process would hypothetically begin in the year 2015. Foods within this category with more than 80 mg per serving could not be legally marketed after 2015.2 After an appropriate additional

2

Use of more than 80 mg of salt per serving in foods within this category would be considered use of an unapproved food additive unless the company marketing the product had received pre-market food additive approval for this level of use. Therefore, the majority of foods with more than 80 mg per serving could not be legally marketed after 2015.



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