The US Food and Drug Administration (FDA) has issued a final rule. It is allowing for safe and suitable salt substitutes in standardized foods. Manufacturers will now get greater flexibility to reduce sodium without changing the foods’ basic nature and important characteristics. The rule takes effect on December 14, 2026. There’s a separate November 12, 2026 deadline for objections and hearing requests. These concern amendments to dairy-product standards.
The Federal Register on October 13, 2026, published this final rule by the name of “Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods.” It amends 80 standards of identity directly. The flexibility extends to 139 standards in total through existing cross-references. The update applies to standardized foods whose standards specify salt (sodium chloride) as a required or optional ingredient.
What Has Changed Under the FDA’s Final Rule?
The FDA has introduced a new provision. It is 21 CFR 130.30, under Part 130, Food Standards: General. It provides the conditions for using salt substitutes in standardized foods. It also allows manufacturers to replace some or all of the added salt.
A salt substitute must be a safe and suitable ingredient. It can also be a combination of safe and suitable ingredients that replaces some or all added salt, reduces sodium, and performs salt’s functions in the food. The substitute must not change the food’s basic nature and essential characteristics.
There has been no published specific list of permitted salt substitutes by the FDA. Manufacturers can choose ingredients or ingredient combinations that meet the definition and the requirements that apply. However, the rule does not independently approve new ingredients. It also doesn’t exempt them from food-additive regulation.
Ingredients must still meet the requirements that apply under the Federal Food, Drug, and Cosmetic Act. It includes premarket authorization for food additives or a valid exemption, like qualifying as generally recognized as safe (GRAS) status.
Which Food Categories Are Covered?
The 80 directly amended standards cover 21 CFR parts. These are 130, 131, 133, 136, 137, 139, 145, 150, 155, 156, 158, 161, 163, 166, 168, and 169. The affected categories include the following:
- Dairy products and cheeses
- Bread and bakery products
- Flour and cornmeal
- Macaroni and noodles
- Canned fruits and vegetables
- Certain seafood products
- Chocolate and cocoa products
- Margarine
- Syrups
- Mayonnaise
- Salad dressings
Existing cross-references extend the flexibility to another 59 standards, bringing the total to 139. The FDA did not amend the oyster standard to permit salt substitutes for processing. It also declined to clearly amend the standards for frozen raw breaded shrimp and frozen raw lightly breaded shrimp.
Food Safety and Labeling Requirements Remain in Force
There aren’t any new labeling requirements. The existing ingredient-declaration rules will continue to be in force. If any salt substitutes are used, their specific common or usual names should be used to declare them. If an ingredient used as a substitute contains a major food allergen, applicable allergen-declaration requirements also remain in force.
Manufacturers that use potassium-based substitutes must adhere to the existing Nutrition Facts requirements for potassium declaration upon meeting the applicable threshold. Under 21 CFR 101.9(c)(8), quantitative potassium information is required. It’s needed when the food contains at least 2% of the Daily Value for potassium per serving.
Manufacturers also need to check the role of salt in each product before they reformulate. Salt can affect taste, moisture, stability, and microbial safety. When a substitute is added, it must perform the functions equally as needed in the specific food. There shouldn’t be any compromise to its safety, quality, or essential characteristics. The FDA’s rule does not prescribe a minimum level of sodium reduction. It also doesn’t require manufacturers to reformulate their products.
Technical Updates and Regulatory Impact
The FDA has updated some incorporated references. These include specified analytical methods from the Official Methods of Analysis of AOAC INTERNATIONAL, 22nd edition (2023). It has also made technical amendments to correct inconsistencies and typographical errors in several standards of identity.
Those manufacturers that don’t use salt substitutes face no new regulatory penalties under this rule. The companies that wish to reformulate will have to incur & estimate the following:
- Development costs
- Validation expenses
- Relabeling costs
- Effects on product characteristics
- Consumer acceptance
Key Dates and Actions for Manufacturers
The final rule becomes effective on December 14, 2026. The exception applies to any dairy-standard provisions stayed by properly filed objections.
Companies affected by amendments to dairy-product standards under 21 CFR parts 131 and 133 may submit objections and requests for a hearing. They must do so by November 12, 2026. Each objection must be separately numbered. It should look into the specific provision being challenged and lay the grounds for the objection. If there’s a hearing request, it must be specified in the objection. It should include the required detailed description and analysis of the factual information to be presented. If objections come late, they won’t be taken into consideration.
So, food manufacturers and regulatory teams should review affected product standards and assess ingredient safety and functionality. They should verify labeling obligations and decide whether voluntary reformulation is commercially and technically appropriate.
