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culture—to reduce salt in processed and restaurant foods.”10 A petition submitted to FDA in 2005 (CSPI, 2005) cited, among other reports, the congressional committee’s statement and requested FDA to (1) revoke the GRAS status of salt, (2) amend any prior sanctions for salt, (3) require food manufacturers to reduce the amount of sodium in all processed foods, (4) require health messages on retail packages of salt (≥ 0.5 oz.), and (5) reduce the Daily Value (DV)11 for sodium from its current level of 2,400 mg to 1,500 mg. In response to the petition, FDA held a public hearing in November 2007 to discuss the regulatory status of salt. The comment period for additional responses to the public hearing and the petition closed in August 2008 (HHS/FDA, 2008). To date, no further FDA action on this petition has taken place.

The Government Accountability Office (GAO) has also undertaken a study related to GRAS, which was released in February 2010 (GAO, 2010). The objectives of this work included determining the extent to which FDA’s oversight of GRAS determinations helps ensure the safety of food ingredients and the extent to which FDA reconsiders GRAS determinations. This study found that FDA does not systematically reconsider the safety of GRAS substances as new information becomes available and that the agency has acted slowly on petitions regarding GRAS status of substances including salt due to resource constraints and other priorities. As a result, one of the recommendations of the GAO report was that FDA “develop a strategy to conduct reconsiderations of the safety of GRAS substances in a more systematic manner, including taking steps such as allocating sufficient resources to respond to citizen petitions in a timely manner, [and] developing criteria for the circumstances under which the agency will reconsider the safety of a GRAS substance.”

Options for the GRAS Status of Salt on the Basis of Safety Concerns

As described above, there are two regulatory options for salt added to foods, other than maintaining the status quo of salt as a GRAS substance with no specified conditions of use. One option is to revoke the GRAS status, requiring a petition process for approval before marketing. The second is to retain salt as a GRAS substance but specify the conditions of use under which the continued addition of salt to foods can be considered safe. This would not require petitions, but food manufacturers would be required to formulate their food in such a manner that the salt levels are consistent with those recognized as safe. Uses or levels of salt in foods that could not meet the new standards could, through a petition process, be put forward as food

10

H.R. Rept. 109-143. 109th Congress, 1st session. (June 21, 2005) at 142.

11

The value used for nutrition labeling of packaged foods.



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