U.S. FDA grants qualified health claim for high-oleic oils and cardiovascular disease

According to a recent statement from FDA Commissioner Scott Gottlieb, the U.S. Food and Drug Administration (FDA) has granted a qualified health claim for use on labels 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 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% oleic acid to meet the criteria for the new qualified health claim. Specific edible oils include high-oleic sunflower oil, high-oleic safflower oil, high-oleic canola oil, olive oil, and high-oleic algal oil. Some high-oleic oils were developed as alternatives to partially hydrogenated oils, which are no longer added to most foods, and 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 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% 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.