FDA Approves Salt-Alternative Use in 80 Common Foods, Raising Caution for Certain Medications

If you need to limit potassium, it pays to inspect food labels carefully.

People with chronic kidney disease or heart failure, as well as those taking certain blood pressure medicines, should pay closer attention to ingredient lists once the new rule begins to take effect.

The Food and Drug Administration has finalized a rule that could allow added potassium in foods that did not previously contain it.

The agency completed the rulemaking process in the Federal Register. It changes the “standards of identity,” the detailed recipes that determine what a food must include to be sold under a specific name.

For instance, a product cannot legally be called “mayonnaise” unless it follows the government’s exact mayonnaise standard, which previously did not permit salt substitutes.

Under the change, manufacturers may replace some or all of the added salt in 80 common foods, including cheese, ketchup and canned tuna.

Why the medication warning matters

The FDA did not single out one substitute, but potassium chloride was mentioned most often in public comments on the rule. For many consumers, that will not be a concern.

For some people with certain health conditions, however, excess potassium can accumulate in the blood instead of being removed by the body. That problem, known as hyperkalemia, can lead to an irregular heartbeat and, in serious cases, cardiac arrest.

People at greater risk include those with kidney disease or heart failure. The National Institutes of Health also says certain blood pressure and heart medications can increase the risk, including:

• ACE (angiotensin-converting enzyme) inhibitors, such as benazepril (Lotensin)
• ARBs (angiotensin receptor blockers), such as losartan (Cozaar)
• Potassium-sparing diuretics, such as amiloride (Midamor) and spironolactone (Aldactone)

These drugs reduce the amount of potassium the body eliminates through urine, which can push levels too high, especially when kidney function is impaired. The NIH says hyperkalemia can occur even when these people eat ordinary amounts of potassium from food, and it recommends speaking with a health care provider before using salt substitutes.

Some people may not know they are at risk. The Centers for Disease Control and Prevention says about 9 in 10 adults with chronic kidney disease do not know they have it, and more than 1 in 5 adults with high blood pressure are estimated to have the condition.

The FDA considered requiring a warning label on foods made with potassium-based substitutes, but ultimately decided not to.

The agency said potassium already has to appear on the Nutrition Facts label once a food reaches 2% of the daily value, and any substitute must be named specifically in the ingredient list rather than hidden behind a broad term such as “salt substitute.”

That means the information will be available, but consumers will need to look for it.

Foods to watch closely

The new flexibility for salt substitutes applies to the following foods:

• Cheese: Cheddar, mozzarella, Swiss, cream cheese, cottage cheese, Parmesan, blue cheese, Colby and more than 30 other cheese standards
• Dairy: Sour cream, cultured milk, eggnog
• Canned vegetables: Green beans, corn, peas, tomatoes, mushrooms
• Condiments: Ketchup, mayonnaise, salad dressing
• Canned fish: Tuna, salmon, shrimp, oysters
• Baked goods and grains: Bread, self-rising flour, macaroni, noodles
• Other staples: Margarine, maple and cane syrup, chocolate

Why the change was made

The FDA says more than 70% of the sodium in the average American diet comes from processed, packaged and restaurant foods.

Federal dietary guidelines set a limit of 2,300 milligrams of sodium a day for people age 14 and older. Eating too much sodium is linked to high blood pressure, a major risk factor for heart disease and stroke.

Manufacturers have already been working toward voluntary sodium targets established in 2021. But for standardized foods, the old formulations left little room to reach those goals without breaking the product’s legal definition.

What consumers can expect

The rule takes effect Dec. 14, but reformulating products takes time, so shoppers should not expect immediate changes in grocery stores.

The rollout is likely to happen gradually, with manufacturers deciding product by product whether a lower-sodium version is worth making. Because potassium chloride can taste bitter or metallic in larger amounts, the FDA expects that will also limit how much companies use.

Anyone taking the medications listed above should ask a doctor whether blood potassium levels should be checked, especially before buying lower-sodium versions of everyday foods.

MedlinePlus, a service of the National Library of Medicine, says regular potassium and kidney blood tests are standard for people taking heart or blood pressure medications.