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have been granted on a case-by-case basis to specific companies for specific products, and therefore reflect a very insignificant sodium contribution to the food supply.

However, even if prior-sanctioned uses of substances are identified and are considered by legal authorities to be permanently exempted from the food additive law, they remain subject to review for safety. The authority for this is within the so-called adulterations standards specified in 21 CFR 181.1(b). As FDA itself stated in 1982 and encapsulated in the CFR,13 the safety determinations reflected in those prior sanctions may be reviewed and modified where appropriate, when “scientific data or information… shows that use of a prior-sanctioned food ingredient may be injurious to health.” It should be noted that such activities must meet a higher legal standard compared to those established for the food additive provisions. Moreover, for prior-sanctioned substances, the burden would likely rest on FDA to demonstrate that such regulation is needed to prevent possible harm. In any event, while prior-sanctioned uses would constitute a technical issue for the agency, its impact is expected to be insignificant in terms of sodium contribution to the food supply particularly in contrast to the levels under the GRAS provisions.

Implementation

FDA has great flexibility in adopting regulatory standards. It may determine appropriate implementation periods for new standards and take into account factors such as consumers’ acclimation to changes in the salt taste of products. Other feasibility and related constraints may be considered in implementing new standards, including possible phase-in reductions to acceptable levels.

In considering implementing salt GRAS standards in a stepwise fashion, FDA will benefit from the experience gleaned from the effort to reduce, in a sequential manner over time, the allowable levels of sodium in foods bearing the implied nutrient content claim “healthy.” That experience demonstrates the considerable importance of gathering information and carefully weighing options before making final decisions about an implementation process relative to sodium. It would appear that if the effort results in too rapid an implementation without sufficient regard to the need to make related changes in all food products, the outcome may not be accomplished successfully.

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21 CFR 181.1(b).



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