FDA Allows Claim About Oleic Acid’s Possible Heart Benefits on Labeling

The US Food and Drug Administration (FDA) will allow a new “qualified health claim” to be placed on the labels of oils with high levels of oleic acid, a monounsaturated fat, stating that consumption of about 1.5 tablespoons (20 grams) of such oils may reduce the risk of coronary heart disease, the agency announced Monday.

The claim must be accompanied by disclaimers that there is supportive but not conclusive evidence for it and that the oleic acid-containing oils should replace fats and oils higher in saturated fats. The overall numbers of calories consumed in a day should not be increased to accommodate consumption of oleic acid-containing oils.

According to a statement from FDA Commissioner Scott Gottlieb, MD, claims on labels are part of the agency’s Nutrition Innovation Strategy aimed at promoting public health through nutrition.

“These claims serve as efficient signals that consumers can look for on a product’s packaging to determine what benefits a food or beverage might have,” Gottlieb said. “By allowing such claims on food product labels, we at the FDA also hope to encourage the food industry to reformulate products.”

There are two types of health claims: authorized and qualified. An authorized claim is supported by “significant scientific agreement” in the literature, whereas evidence is more limited for a qualified claim.

Responding to a petition for a new health claim from Corbion Biotech Inc. (formerly TerraVia Holdings), a manufacturer of ingredients for foods and biochemicals, the FDA determined that available evidence supported a qualified—but not authorized—claim. Out of seven studies identified, six showed that eating a diet that included oils with high levels of oleic acid lowered total and LDL cholesterol levels compared with a Western-style diet higher in saturated fats. There was no evidence that the improvements would be obtained without displacing saturated fats from the diet.

The new claim applies to oils containing at least 70% oleic acid. That includes olive oil and high-oleic acid forms of sunflower, safflower, canola, and algal oils.