FDA Will Let Salt Substitutes Into Standardized Foods From Dec. 14. Patients Who Limit Potassium Should Read Labels.
A final rule published Oct. 13 lets manufacturers replace some or all added salt in foods such as canned vegetables, canned tuna and cheeses. FDA does not name the substitutes, but potassium chloride is the familiar one.
The Food and Drug Administration published a final rule on Oct. 13 that lets manufacturers use salt substitutes in standardized foods, the products whose recipes are fixed by federal standards of identity. Until now, standards that list salt as a required or optional ingredient left little room to swap it out. The rule takes effect Dec. 14.
FDA frames the rule as a sodium-reduction measure. For clinicians, the more immediate question is potassium, since potassium-based salt substitutes are the familiar option and some patients need to limit potassium.
What the rule does
The rule amends the standards of identity that name salt (sodium chloride) so that “safe and suitable” salt substitutes can replace some or all of the added salt. It uses a single definition that applies across those standards rather than listing specific ingredients. The amended standards include canned vegetables, tomato juice, frozen peas, canned tuna and salmon, and dairy products, including cheeses. Salt substitutes could already be used in foods without a standard of identity.
FDA first proposed the change in April 2023. It cites the Dietary Guidelines advice that people 14 and older consume less than 2,300 mg of sodium a day, and says more than 70 percent of Americans' sodium intake comes from sodium added during manufacturing and commercial food preparation. Reformulation is voluntary, and FDA says it received no information on how many foods will be changed or which substitutes manufacturers will use. Objections to the dairy amendments can be filed until Nov. 12.
The rule does not require anyone to use potassium. It does mean the potassium content of familiar staples may change without the product name changing.
The potassium question
Commenters warned that potassium-based substitutes could affect people with chronic kidney disease or heart failure, or who take medications that raise the risk of hyperkalemia, and that some patients do not know they have kidney disease or do not read labels. Other comments said the evidence linking these ingredients to hyperkalemia is limited and more research is needed.
FDA's response relies on labeling. Foods with 2 percent or more of the daily value for potassium per serving must list potassium on the Nutrition Facts label, and the ingredient list must say “potassium chloride” or “potassium salt” when it is used. FDA says it will monitor data on U.S. potassium intake.
What to tell patients
For most patients with hypertension, lower-sodium versions of everyday foods are welcome. For patients on a potassium restriction, including those with advanced kidney disease and some on medications that raise potassium, the advice is to check the ingredient list and the potassium line on the Nutrition Facts label, even for foods they have bought for years. Dietitians who counsel these patients may want to flag the change before reformulated products reach shelves.
Reported, fact-checked and edited by The Script Pad's editorial staff.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
