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Use of Salt Substitutes Expanded to Help Lower Sodium Intake

  • On March 24, the U.S. Food and Drug Administration (FDA) proposed changes to the standards of identity (SOIs) for foods that include salt to permit the use of safe and suitable salt substitutes.  The proposed rule, “Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods,” is part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health and complements the goals of the FDA’s voluntary sodium reduction targets for processed, packaged, and prepared foods.

  • Most SOIs that feature salt as a required or optional ingredient would preclude the use of salt substitutes.  The proposed rule uses a “horizontal” approach to updating the SOIs.  Specifically, it would amend the 80 relevant SOIs.  Because these 80 SOIs are referenced in other SOIs, 140 of the 250 SOIs currently established would be affected.

  • The proposed rules does not list permitted salt substitutes, but defines them as safe and suitable ingredients used to replace some or all of the salt in a standardized food.  The extent to which salt can be replaced depends on the ability of salt substitutes to replace the functions of salt without compromising the food safety or essential characteristics of the food.  Salt substitutes are subject to the same labeling requirements as other ingredients.

  • FDA will be accepting comments to the proposed rule 120 days after it is published in the Federal Register.  Specifically, FDA requests comments on potential salt substitutes that may be used as a result of the new flexibility provided by the proposed rule.  Keller and Heckman will continue to monitor this area and relay any developments.

© 2023 Keller and Heckman LLPNational Law Review, Volume XIII, Number 89
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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