On March 24, the US Food and Drug Administration (FDA) released a proposed rule to revise the standards of identity (SOIs) for salt-containing foods. The proposed rule would allow the use of safe and appropriate salt substitutes and provide the food industry with greater flexibility in lowering sodium levels in food and drinks. The FDA explains that SOIs typically specify required and optional ingredients for a particular food, and some also dictate the production or formulation process. However, most of the existing 250+ SOIs in the US do not allow for the use of salt substitutes in lieu of salt.

The proposed rule would adopt a “horizontal” approach to updating SOIs, impacting numerous SOIs and food categories. The proposed rule would modify 80 SOIs that currently list salt as either a required or optional ingredient, affecting a total of 140 SOIs as these 80 SOIs are referred to in other SOIs. For instance, salt is optional in the SOIs for bread, rolls, and buns. The proposed rule would not specify specific salt substitutes but instead cover ingredients or combinations of ingredients used as salt substitutes. The proposed rule defines salt substitutes as safe and suitable ingredients or a blend of ingredients used to substitute some or all of the salt in standardized food.

Robert M. Califf, MD, FDA commissioner, said, “Today’s action is another step forward in our efforts to improve nutrition and reduce chronic disease by providing manufacturers another tool to lower the use of sodium in food production. This approach may help reduce Americans’ sodium intake and lower their risk of hypertension, a leading cause of heart disease and stroke.”

Susan Mayne, PhD, Director of the FDA’s Center for Food Safety and Applied Nutrition, said, “Most people in the US consume too much sodium. The majority of sodium consumed comes from processed, packaged and prepared foods, not from salt people add to their food when cooking or eating.”

The FDA will accept comments on the proposed rule for 120 days after its publication in the Federal Register, with electronic comments available via www.regulations.gov and written comments by mail. All submissions must contain the Docket No. FDA-2022-N-2226. The proposed rule is a component of the Biden administration’s National Strategy on Hunger, Nutrition, and Health, which aims to end hunger and reduce diet-related illnesses by 2030.

Potassium chloride was mentioned numerous times in the FDA proposal. Currently, the SOI for margarine allows for the use of potassium chloride in dietary margarine production. Potassium chloride is a Generally Recognized As Safe (GRAS) substance, as per the FDA. In December 2020, the FDA announced that it would approve the term “potassium salt” instead of potassium chloride in ingredient listings on product labels. Additionally, the FDA proposes to allow the use of salt substitutes in 41 SOIs for cheeses and related cheese products.

In October 2021, the FDA issued guidance for the food industry, finalizing short-term, voluntary sodium reduction targets in over 160 categories of packaged and restaurant-prepared foods. Americans consume an average of 3,400 mg of sodium daily, while the Dietary Guidelines for Americans suggests that adults consume less than 2,300 mg per day. Sodium added during food manufacturing and commercial preparation accounts for over 70% of the sodium consumed in the United States.