Food and beverage manufacturers once constrained by standards of identity requiring salt in more than 100 products, from dinner rolls and canned tuna to salad dressing and sour cream, now have greater flexibility to reduce sodium under a new FDA final rule.
Today, the FDA finalized a rule allowing manufacturers to use salt substitutes in 139 standardized foods where salt (sodium chloride) is currently required or permitted under the food’s standard of identity, but salt substitutes are not.
The rule published Oct. 13 comes as FDA continues to pursue voluntary sodium-reduction goals for commercially processed, packaged and prepared foods aimed at cutting Americans’ daily intake of the nutrient by 20% to reduce diet-related diseases associated with overconsumption of sodium.
The agency’s draft guidance for Phase II targets include 163 food categories and subcategories, some of which are included in the Oct. 13 final rule relaxing the use of salt in some standardized food. These build upon the Phase 1 targets finalized in 2021 for which FDA said in this rule it would issue a progress report later this year.
The imputes behind both efforts is to help Americans reduce their sodium intake to about 2,750 milligrams a day as outlined under the proposed Phase II sodium reduction targets. This is higher than the cap of 2,300 milligrams per day set by the Dietary Guidelines for Americans older than 14 years but also about 20% lower than consumption levels prior to 2021, according to FDA.
This goal aligns with the Trump administration’s Make America Healthy Again initiative, which emphasizes improving nutrition and addressing diet-related chronic disease.
What will change?
Under the rule, FDA will permit the use of salt substitutes across 80 standards of identity. Because 59 additional standards cross-reference those amended standards, the change extends to 139 standards in total.
Standards of identity were originally established by the agency to protect consumers from misleading product names and to ensure consistency in food production. For example, they may require or permit ingredients, proportions, manufacturing methods and other characteristics. And, depending on the standard, they may restrict substitutions – such as for salt.
Before the rule, most standards of identity that specified salt did not permit manufacturers to replace it with salt substitutes. Some flexibility already existed, however, under FDA’s general provisions for certain foods bearing nutrient-content claims, including low-sodium cheddar and Colby cheeses. Manufacturers could also use qualifying substitutes in frozen raw breaded shrimp because its standard did not explicitly specify salt as an ingredient. FDA also allowed the use of potassium chloride as a substitute in dietary margarine.
Rather than limiting manufacturers to a list of approved substitutes, FDA defines a salt substitute as a safe and suitable ingredient or combination of ingredients that replaces some or all of the added sodium chloride, reduces sodium and performs at least one of salt’s functions in the food. The ingredients must comply with existing food-safety requirements, including applicable food-additive rules.
The substitutes must still preserve the food’s “essential characteristics,” according to the rule. This includes maintaining a product’s identity requirements.
It also must maintain the other functions that salt provides in a product.
“Depending on the food, salt may be important for taste, microbial safety or other functions,” according to the rule.
It adds: “The extent to which salt can be replaced depends on the ability of the salt substitute to replicate the functions of salt in the food without compromising the food’s safety and nutritional quality. For this reason, relying on sodium reduction alone, without the use of salt substitutes or limiting to specific ingredients such as herbs and spices only to replace salt, may not sufficiently help with the overall reduction in sodium in the food supply.”
What foods are affected?
The affected products span a range foods.
Examples include many types of cheese; bread, rolls and buns; self-rising flour and cornmeal; macaroni and noodle products; canned vegetables, fruits and certain fish or shellfish; tomato products; chocolate and cocoa products; and margarine, mayonnaise and certain syrups.
Why did FDA relax the rule for salt substitutes?
FDA amended the rule in part to allow companies to make lower-sodium versions of familiar products to comply both with changing consumer tastes and health preferences, and the agency’s overarching sodium reduction goals.
Currently, more than 70% of Americans’ sodium intake comes from foods where sodium is added during food manufacturing and commercial food prep – making it difficult for individuals to reduce their overall sodium consumption without lowering the amount in commercially processed, packaged and prepared foods in the US marketplace, FDA explains in the rule.
It adds the final rule “supports the Make America Healthy Again initiative by providing manufacturers of standardized foods flexibility to innovate and make more healthful, lower-sodium foods, which may help lower chronic disease rates.”
What are the limits?
The rule drew more than 120 comments, with some raising concerns about the safety of salt substitutes, particularly potassium-based ingredients, and potential risks for consumers who need to limit potassium intake. FDA said the rule does not authorize otherwise unapproved food additives and that substitutes must meet existing safety requirements.
When will the rule take effect?
Because FDA is using two different legal procedures to make changes under the final rule, most of the amendments will take effect Dec. 14 without an additional objection period.
However, the standards covering milk products and cheeses fall under a different provision of the Food, Drug and Cosmetics Act that allows for additional formal objections and a request for a hearing on specific amendments. The due date for those objections is Nov. 12.
