FDA salt substitutes final rule for 139 standardized foods
FDA's salt substitutes final rule lets makers replace salt in 139 standardized foods from 14 December 2026. What changed, labeling and the dairy deadline.
What the FDA salt substitutes final rule changes for standardized foods
The FDA salt substitutes final rule lets manufacturers replace some or all added salt in 139 standardized foods whose standards of identity list salt as a required or optional ingredient. It takes effect on 14 December 2026, except where a proper objection stays a dairy provision. The rule amends 80 standards of identity directly and reaches the other 59 through existing cross-references.
Use is voluntary and FDA set no compliance date. The substitute goes on the label under its own common or usual name. The dairy amendments in 21 CFR 131 and 21 CFR 133 stay open to objections and hearing requests until 12 November 2026.
FDA published the rule on 13 October 2026 at 91 FR 65040. It follows the 10 April 2023 proposal.
What changed in the standards of identity
For covered foods, using salt substitutes previously required the modified-standard route in § 130.10. That route requires the food to meet a § 101.61 sodium nutrient content claim, which FDA says "may be impracticable" (FR).
The rule adds a new subpart C, "Flexibility in Standardized Foods", to part 130, with a new § 130.30. Its definitions apply to parts 131 through 169. The core definition reads (FR PDF, p. 65055):
"Salt substitute means a safe and suitable ingredient (or combination of safe and suitable ingredients) that is used to replace some or all of the added salt (sodium chloride), to reduce sodium in the food, and that serves the functions of salt in the food."
Section 130.30(b) adds a limit: the substitute "must not change the basic nature and essential characteristics of the food" (FR PDF, p. 65055).
The rule approves no new ingredient and gives no list of permitted substitutes. FDA discusses potassium chloride and monosodium glutamate (MSG) as examples. Each ingredient must already be lawful for that use, as an approved food additive or GRAS, and must meet the "safe and suitable" test in § 130.3(d). That means it performs an appropriate function, is used at no higher level than needed, and isn't an unapproved food additive or color additive (final rule).
The wording added to each standard varies. The ingredient line for bread, rolls and buns (§ 136.110) and for mayonnaise (§ 169.140) becomes "Salt or salt substitute." Cheddar cheese (§ 133.113(b)(3)(vi)) gets a new optional line, "Salt substitute." Colby cheese (§ 133.118) is narrower: salt substitute may be used "where the curd is salted." Margarine (§ 166.110) is written as "Salt (sodium chloride) or salt substitute; potassium chloride for dietary margarine or oleomargarine." Check the exact paragraph for each standard you make (FR PDF).
The rule also updates referenced AOAC methods to the 22nd edition (2023) and corrects "mapel" to "maple" in the maple sirup standard (§ 168.140(a)). Some standards, including milk, creams and flour, were changed for methods only and got no salt substitute option (rule text).
Which standards are covered
FDA says the rule "permits the use of salt substitutes in 139 SOI: 80 SOI by amendment to the SOI in the final rule and the remaining 59 SOI by an existing cross-reference" (FR). The 80 directly amended standards split by part as follows (FR PDF):
| 21 CFR part | Examples | Count |
|---|---|---|
| 131 Milk and cream | acidified milk, cultured milk, sour cream, eggnog | 5 |
| 133 Cheeses | cheddar, colby, mozzarella, cream cheese, Swiss, process cheese foods and spreads | 41 |
| 136, 137, 139 Bakery, flours, pasta | bread, self-rising flour, macaroni and noodle products | 5 |
| 145, 150 Fruits | applesauce, figs, fruit butter | 3 |
| 155, 156, 158 Vegetables | canned corn, peas, tomatoes, catsup, tomato juice, frozen peas | 10 |
| 161 Fish and shellfish | canned oysters, canned Pacific salmon, canned tuna, wet pack shrimp (stayed) | 4 |
| 163 Cacao | sweet, white and milk chocolate, breakfast cocoa | 5 |
| 166, 168, 169 Margarine, sirups, dressings | margarine, maple sirup, mayonnaise, salad dressing | 7 |
Dairy makes up 46 of the 80. Two details are easy to miss. Canned wet pack shrimp (§ 161.173) is in that count, but the rule lifts a 1979 stay, revises the ingredient line, then stays paragraphs (a) and (c) indefinitely again. The option can't be used there. For canned peas (§ 155.170), the rule lifts a 1981 stay on paragraph (a)(2) (46 FR 35086). FDA turned down requests to add oysters (§ 161.130) and two frozen raw breaded shrimp standards. Part 165 is not touched. Meat and poultry standards belong to USDA-FSIS and sit outside this rule (final rule).
How the salt substitute must be labeled
The rule adds no new labeling requirements (FR). Declare the substitute in the ingredient statement by its common or usual name under § 101.4(a)(1) and § 130.3(e). "Salt substitute" is defined, but the rule does not establish it as a collective name, so it can't stand in for the real ingredient on the ingredient list.
FDA explains the existing requirements in the final rule's labeling responses:
- Potassium chloride must be declared as "potassium chloride" or "potassium salt".
- MSG used as a substitute must be declared as "monosodium glutamate".
- Allergen declaration under section 403(w) of the FD&C Act still applies if the substitute is or contains an allergen.
- Potassium must be declared on the Nutrition Facts label under § 101.9(c)(8)(ii) when the food has 2% or more of the daily value.
- A "low sodium" claim must still meet § 101.61(b)(4). Potassium claims follow §§ 101.13 and 101.54.
FDA refused a hyperkalemia warning and a mandatory front-of-pack potassium or "reformulated" statement. A voluntary statement is allowed if it is truthful and not misleading (final rule).
The older low sodium cheese standards work differently, and the final rule doesn't mention them. Low sodium cheddar cheese (§ 133.116) and low sodium colby cheese (§ 133.121) still require the label statement "______ added as a salt substitute" when one is used.
The 12 November dairy objection deadline
The amendments to 21 CFR 131 and 21 CFR 133 were issued under section 701(e) of the FD&C Act, which is formal rulemaking. The rest were issued under sections 401 and 701(a). This window is for objections and hearing requests, not comments.
File in docket FDA-2022-N-2226 at regulations.gov by 11:59 p.m. Eastern Time on 12 November 2026. Paper submissions count if received by that date. Late ones are not considered. FDA will publish a Federal Register notice of the objections it received, or that it received none. A proper objection can stay the dairy provision it targets, so the 14 December date is not settled for parts 131 and 133 until that notice (FR).
To check a specific standard, ask RegAffairs AI about the salt substitutes rule and open its cited text. Before reformulating, read that standard's amendment and any stay that still applies.