The US Food and Drug Administration (FDA) has responded positively to a petition for a new qualified health claim for edible oils containing oleic acid. As a result, products with an oleic acid content upward of 70 percent, such as certain olive, canola and sunflower oils, can be labeled as carrying cardiovascular benefits, but only when replacing heart-damaging saturated fat.

The FDA recognizes two kinds of health claims on food product packages: authorized health claims and qualified health claims. As noted by FDA Commissioner Scott Gottlieb in a statement released yesterday, an authorized health claim meets the more rigorous standard of “significant scientific agreement.” 

As is the case with oleic acid and heart health benefits, a qualified health claim means scientific evidence is more limited. To ensure qualified claims are not misleading to consumers, the agency stipulates that these must include a disclaimer to communicate to consumers the level of scientific evidence supporting the claim.

Manufacturers of high oleic acid oils can choose to include a qualified health claim on their label that reads “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.” 

Manufacturers will, however, have to make it clear that these oils “should replac fats and oils higher in saturated fat and not increase the total number of calories you eat in a day” to achieve this cardiovascular health benefits,

Oleic acid can be found naturally in a range of food sources, including edible oils, meat, cheese, nuts, sunflower seeds, eggs, pasta, milk, olives and avocados. 

The FDA decision on the qualified health claims respond to a petition filed in 2016 by Corbion Biotech, Inc. (known at the time of the filing as TerraVia). In its petition, the company identified the following edible oils that contain at least 70 percent of oleic acid per serving: 
1) High oleic sunflower oil;
2) Hgh oleic safflower oil; 
3) High oleic canola oil; 
4) Olive oil, and; 
5) High oleic algal oil.

Although the science behind the new qualified health claim for oleic acid is not conclusive, the FDA notes that it is “promising.” 

The decision was based on the results of seven small clinical studies that evaluated the relationship between the 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. 

Of those seven studies, six reportedly showed that study participants 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. This 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. This was unless they replaced other types of fats and oils that were higher in saturated fats in the diet.