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additive uses and have the potential for approval. This does not mean that the standard of safety is different between the GRAS approach and the food additive approach, only that there is the option, after the determination that a general recognition of safety does not exist, to permit the substance to be used as a food additive concurrent with whatever restrictions are needed to ensure its safe use.

Key Components of the Process

FDA action to either alter or revoke the GRAS status of salt would involve an established rulemaking process (see Appendix H) that would include, at a minimum, (1) public notice of proposed actions and a justification for the actions based on the available science, (2) an opportunity for public comment, and (3) a reasoned FDA response to the comments. Even prior to publishing such a proposal, FDA could publish an advanced notice of proposed rulemaking, commonly referred to as an ANPR, to outline its initial thinking and to gather information on key issues. These include but are not limited to relevant data ranging from technical processes to consumer behaviors. As part of the process, the agency could also hold public meetings, hearings, scientific consultations, or other dialogue as appropriate to resolve the GRAS status of added salt and determine the agency’s regulatory and policy approaches.

In carrying out activities to alter or revoke salt’s GRAS status, FDA would have to address both scientific and policy questions, including the following:

  • The central question, which is predominantly scientific, is whether the current levels and uses of added salt satisfy the safety standard of “reasonable certainty of no harm” based on today’s science. In addressing this question, FDA would be expected to take into account, among other sources of information and scientific findings, the recommendations of and scientific advisory documents related to the Dietary Guidelines for Americans, which in 2005 established a recommendation of less than 2,300 mg/d of sodium for the general population and no more than 1,500 mg/d for those with hypertension, African Americans, and people middle-aged or older as appropriate upper limits to reduce the risk of elevated blood pressure. Dietary Reference Intakes for sodium as established by the Institute of Medicine (IOM) might also be relevant. Consistent with the provisions established in law (21 USC 348[c][5][B]), the agency would use a total population “exposure” approach for determining the safety of salt or sodium.



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