The US Food and Drug Administration (FDA) issued a final rule permitting safe and suitable salt substitutes in the 139 standardized foods whose standards of identity specify salt, amending 21 CFR parts 130, 131 and 133. The FDA announced the rule in a constituent update dated October 9, 2026; it publishes in the Federal Register as document 2026-20848 and takes effect December 12, 2026, 60 days after its Federal Register publication.
From December 12, 2026, US manufacturers and importers of those 139 standardized foods, and the formulators reformulating them for sodium reduction, may use safe and suitable salt substitutes while keeping the standardized food name; reformulators must update ingredient declarations and any sodium-related nutrient content claims on labels, or a standardized food that uses a substitute before that date or without updated labeling remains non-compliant with its standard of identity and misbranded under the Federal Food, Drug, and Cosmetic Act. The rule is permissive, so manufacturers who do not reformulate face no sanction, but acting before the effective date or skipping the label updates forfeits the SOI safe harbor.
What does the final rule permit, and from when?
Before the rule, the 139 standards of identity (SOI) that require or allow salt (sodium chloride) did not permit a substitute, so a manufacturer who swapped in a potassium chloride blend to cut sodium lost the right to call the product by its standardized name (for example a Part 133 cheese). The final rule, issued under the FDA's authority over food standards in the FD&C Act, adds salt substitutes as an option in every SOI that specifies salt, effective December 12, 2026. A "salt substitute" is a safe and suitable ingredient used to replace some or all of the salt; the rule sets no specific replacer or minimum sodium reduction, leaving the formulation to the manufacturer.
Which standardized foods and manufacturers are covered?
The 139 affected SOIs sit across 21 CFR parts 130 (general food standards), 131 (milk and cream) and 133 (cheeses and related cheese products), covering staples such as cheese, butter and other standardized dairy and grocery foods whose definitions call for salt. The exposed actors are the US manufacturers of those foods, US importers of standardized foods subject to the SOI regulations, and the food formulators and product-development leads reformulating them for sodium reduction. Companies that make non-standardized foods, or standardized foods whose SOI does not list salt, sit outside the rule's scope.
| Before the final rule | From December 12, 2026 |
|---|---|
| Salt substitutes not permitted in the 139 SOI foods | Safe and suitable salt substitutes permitted, standardized name kept |
| Reformulating for sodium meant dropping the SOI or keeping full sodium | Ingredient declarations and sodium nutrient content claims must reflect the substitute |
What must reformulators change on their labels?
For manufacturers who choose to use a salt substitute, the rule shifts two label obligations. Ingredient declarations must list the substitute by its common or usual name (for example "potassium chloride"), and any sodium-related nutrient content claim, such as "low sodium" or "reduced sodium", must be updated to reflect the reformulated product's actual sodium level. The SOI itself continues to govern the food's name and basic composition; only the salt component may be replaced with a safe and suitable substitute. The FDA frames the change as enabling innovation toward its multi-phase Voluntary Sodium Reduction Goals and the Make America Healthy Again initiative, with a Phase I progress evaluation due later in 2026.
What happens if a substitute is used before the effective date?
The rule carries no penalty for inaction: a manufacturer who keeps using salt in a standardized food is not sanctioned. The risk sits with early or incomplete adoption. Using a salt substitute in an SOI food before December 12, 2026, or using one after that date without the updated ingredient declaration and sodium claims, leaves the food non-compliant with its standard of identity and therefore misbranded under the FD&C Act, which exposes it to FDA enforcement actions including warning letters, seizure and injunction. Importers face the same misbrandment exposure at the border for standardized foods that do not meet the SOI as amended.
Continuous, per-jurisdiction real-time monitoring surfaces this kind of change the moment it publishes in the Federal Register.
Next steps: confirm whether any of your standardized products fall under the 139 affected SOIs in 21 CFR parts 130, 131 or 133; for those that do, brief formulation and labeling teams on the December 12, 2026 effective date; and, if you plan a sodium-reduction reformulation, sequence the ingredient declaration and nutrient content claim updates so they land with, not after, the substitute switch.
