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The FDA issued a final rule allowing manufacturers to use suitable salt substitutes in 139 food categories, including bread, milk and condiments. The change loosens certain food standards of identity but does not require companies to reformulate products or specify which substitutes they must use.

The Food and Drug Administration has issued a final rule allowing manufacturers to use suitable salt substitutes in 139 food categories, including bread, milk and condiments. The change loosens standards of identity that set required ingredients for certain foods, giving companies more flexibility to reduce sodium while keeping products’ basic nature and essential characteristics intact.

The FDA’s rule does not name specific substitutes manufacturers must use. The agency said it is leaving the options open to allow flexibility and future innovation. Any substitute used must not change the food’s basic nature and essential characteristics, according to the rule as described by Food Dive.

Standards of identity define what ingredients certain foods must contain, in part to prevent adulteration and keep products consistent with what consumers expect. In some cases, those requirements meant manufacturers could not remove salt without falling outside the applicable standard. The final rule changes those requirements for the covered foods; it does not set a mandatory sodium limit for each product.

The rule comes amid federal efforts to lower sodium intake. The FDA has issued voluntary sodium reduction guidelines and targets, but the new rule is a separate regulatory change: it permits use of substitutes in specified categories rather than requiring manufacturers to meet a particular reduction amount.

At a glance
updateWhen: Final rule released the week of Oct. 14…
The developmentThe FDA released a final rule allowing suitable salt substitutes in 139 food categories by loosening standards of identity that can require salt as an ingredient.

More Options for Reformulating Foods

The rule removes one regulatory barrier for companies seeking to lower sodium in products where salt had been required by a standard of identity. That could give manufacturers more ways to adjust recipes across staple foods and packaged products, though the rule itself does not guarantee that sodium levels will fall.

The public-health stakes are tied to the amount of sodium Americans consume. The American Heart Association says nearly 90% of Americans exceed recommended daily sodium levels, and packaged foods account for most sodium intake. The association links reducing sodium with lower blood pressure and reduced cardiovascular disease risk; cardiovascular disease is the leading cause of death in the United States.

For consumers, the practical impact will depend on whether manufacturers choose to reformulate, what substitutes they use and whether the resulting products meet consumer expectations. The FDA has provided regulatory flexibility, not a promise that products will change or that consumers’ overall sodium intake will decline.

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How FDA Sodium Targets Fit In

The FDA issued voluntary sodium reduction guidelines in 2021 for manufacturers and foodservice operators. In 2024, the agency added targets intended to reduce average U.S. sodium intake over three years, from more than 3,400 milligrams per day to 2,750 milligrams per day.

Evidence reported by Food Dive suggests progress under the earlier guidelines has been limited: researchers found a median 3% decline in sodium content across food categories after the 2021 guidance, while sodium increased in many restaurant foods. Those findings describe changes following the voluntary guidelines; they do not measure the effect of the new final rule, which has just been released.

The International Dairy Foods Association welcomed the rule but called on the FDA to continue evaluating progress under its existing sodium reduction targets before considering further action. The association represents dairy product makers, including companies producing cheese and yogurt.

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Adoption and Sodium Effects Remain Unknown

The rule does not establish how many manufacturers will use substitutes, which ingredients they will select or how much sodium their products may lose. The FDA has not named required substitute ingredients, and the supplied report does not give a product-by-product list of the 139 categories.

It is also too early to know whether the change will produce measurable reductions in Americans’ sodium intake. The 2021 guideline findings concern earlier voluntary efforts, not this rule. The amount of any future reduction will depend on company decisions, product formulations and consumer acceptance.

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Manufacturers Decide Whether to Reformulate

Food manufacturers can now consider whether to use suitable salt substitutes in the covered categories while complying with the requirement to preserve each food’s essential characteristics. The final rule does not compel a company to change a recipe, so any effects will emerge as businesses make formulation decisions and products reach the market.

The FDA is also expected to continue monitoring progress under its sodium reduction targets. The International Dairy Foods Association has called for that evaluation before the agency considers additional action. No specific timetable for further FDA steps or industry changes is given in the source material.

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Key Questions

What does the FDA’s new rule allow?

It allows manufacturers to use suitable salt substitutes in 139 food categories, including bread, milk and condiments, by loosening relevant standards of identity.

Does the rule require companies to reduce sodium?

No. The rule gives manufacturers flexibility to use substitutes, but it does not require companies to reformulate products or meet a specific sodium-reduction amount.

Which salt substitutes can manufacturers use?

The FDA has not specified a list of required substitutes. According to the report, manufacturers may choose suitable alternatives, provided they do not change the food’s basic nature and essential characteristics.

Will the rule lower sodium in food right away?

That is not yet known. The effect depends on whether companies choose to reformulate and how much sodium they remove. The rule’s release alone does not establish a change in product sodium levels.

Source: rss

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