FDA Approves CVD-Prevention Health Claim for Certain Oils

The FDA has announced that they will approve a petitioned health claim stating that edible oils containing high levels of oleic acid can help to lower the risk of cardiovascular disease when replacing saturated fat.


Specifically, packaging for these products can now include the qualified health claim—which did not meet the evidence requirement to be classified as an “authorized” health claim—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,” clarifying that these products “should replace fats and oils higher in saturated fat and not increase the total number of calories you eat in a day.”


Oils that contain the monosaturated fat include olive oil, high oleic sunflower oil, high oleic safflower oil, high oleic canola oil, and high oleic algal oil.


The decision is based upon data from 7 small clinical studies evaluating the relationship between consuming these oils and cholesterol levels, indicating a reduced risk of coronary heart disease. Of these studies, 6 found that participants randomly assigned to replace saturated fat with the monosaturated fat saw a modest lowering of their total cholesterol and LDL cholesterol levels compared with those consuming a diet higher in saturated fat. None of the studies showed a benefit to consumption of the oils unless they were replacing saturated fats.


“The science behind the new qualified health claim for oleic acid, while not conclusive, is promising,” stated FDA Commissioner Scott Gottlieb, MD. “By allowing such claims on food product labels, we at the FDA also hope to encourage the food industry to reformulate products.”


—Michael Potts


FDA. Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk [press release]. November 19, 2018.