Salty No More: FDA's Potential to Shake Up Hundreds of Standards of Identity

The U.S. Food and Drug Administration (FDA) says Americans consume too much sodium from processed foods. The FDA has issued a proposed rule to amend certain of its standards of identity (SOIs) to allow the use of salt substitutes in foods that require salt or list salt as an optional ingredient.

In October 2021, the FDA issued guidance finalizing short-term voluntary sodium reduction targets in over 160 categories of packaged and restaurant-prepared food. This most recent proposed rule issued by the FDA may help manufacturers meet these voluntary targets, as several foods covered by SOIs are included in the targets. SOIs describe the required and optional ingredients in a food product and sometimes the proportion and method of production or formulation. There are over 250 SOIs, covering products such as dairy products, chocolate, different types of bread, cheeses, and ketchup. Foods that must meet SOIs are referred to as "standardized foods."

While salt substitutes are used in some non-standardized foods, their use is generally prohibited under foods that are subject to an SOI. However, the proposed rule would use a "horizontal" approach, allowing a single rule to apply across multiple SOIs. The proposed rule would amend 80 SOIs that specify salt as a required or optional ingredient, potentially affecting 140 of the 250 established SOIs. Although the proposed rule does not enumerate the salt substitutes that will be permitted, it defines them as "safe and suitable ingredients" to replace some or all of the added sodium chloride in food while still fulfilling the functions of salt in food. The FDA stresses that the amount of salt that can be replaced is contingent on the salt substitute's ability to substitute for salt without affecting food safety or altering the food's characteristics.

Overall, the FDA's proposed rule to allow salt substitutes in standardized foods will likely impact the food industry, potentially affecting the way many products are formulated and marketed. To learn more about the proposed rule and your compliance options, contact Alli Condra or Kim Bousquet.

The proposed rule is now available in the Federal Register, published on April 10, 2023. Comments are due by August 8, 2023. Electronic comments can be submitted to Regulations.gov. Written comments can be submitted to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 

*Simran Kaur is a law clerk in the Portland, Oregon, office of Davis Wright Tremaine.