FDA Approves Cardio Health Claim for High-Oleic Oils

By Dave Fusaro, Editor in Chief

Nov 27, 2018

The FDA on Nov. 19 approved a qualified health claim for edible oils containing high levels of oleic acid, a monounsaturated fat that’s been shown to have cardiovascular benefits when it replaces heart-damaging saturated fat.

"Manufacturers of these oils can choose to include a qualified health claim on their label stating that 'supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, may reduce the risk of coronary heart disease,' ” the agency said on its website.

"The claim will also need to make it clear that to achieve this benefit, these oils 'should replace fats and oils higher in saturated fat and not increase the total number of calories you eat in a day.' ”

Edible oils must contain at least 70 percent oleic acid to meet the criteria for this qualified health claim. Specified edible oils include: high-oleic sunflower oil, high-oleic safflower oil, high-oleic canola oil, olive oil and high-oleic algal oil.

High-oleic soybean oil was not on the list but also qualifies for the claim. "The soybean industry was in the beginning stages of building the market for high-oleic soybean oil when the petition was created," explains a spokesperson for the United Soybean Board. "With its December 2017 global approval, the [soybean] industry is committed to producing 9 billion pounds of U.S.-grown high-oleic soybean oil by 2027, and high oleic soybeans are on track to be the fourth largest row crop by 2024."

Some high oleic oils were developed as alternatives to partially hydrogenated oils (which have been banned) because they will not degrade when heated to high temperatures, which makes them ideal to use for baking or frying.

"The science behind the new qualified health claim for oleic acid, while not conclusive, is promising," the agency said. "The FDA evaluated results from seven small clinical studies that evaluated the relationship between consumption of oils containing high levels of oleic acid (at least 70 percent per serving) and improved cholesterol levels, which indicates a reduced risk for coronary heart disease.

"Six of the studies found that those who were randomly assigned to consume diets containing oils with high levels of oleic acid as a replacement to fats and oils higher in saturated fat experienced a modest lowering in their total cholesterol and heart-damaging low-density lipoprotein (LDL) cholesterol levels compared to those who ate a more Western-style diet that was higher in saturated fat. One study showed no significant effect. Importantly, and as noted in the health claim, none of the studies found that eating oleic acid-containing oils had beneficial heart effects unless they replaced other types of fats and oils higher in saturated fats in the diet."

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