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

FDA Statement

• For Immediate Release: November 19, 2018
• Statement From: Scott Gottlieb, M.D.

As Commissioner of the U.S. Food and Drug Administration, I remain committed to finding new ways to reduce the burden of chronic disease through improved nutrition. Using the FDA’s labeling tools to foster innovation toward healthier foods that consumers want is one of the primary goals of the FDA’s Nutrition Innovation Strategy that I first announced in March.

One tool the FDA has to help bring us closer to this important goal is the use of “health claims” on food package labels. 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. By allowing such claims on food product labels, we at the FDA also hope to encourage the food industry to reformulate products.

Recognizing the importance of science-based food decisions, there are two kinds of health claims on food product packages – authorized health claims and qualified health claims.

An authorized health claim meets the more rigorous standard of “significant scientific agreement,” meaning that the claim is supported by the totality of publicly available scientific evidence for a substance/disease relationship. A qualified health claim means it is supported by more limited scientific evidence that doesn’t meet the rigorous standard. To ensure qualified claims aren’t misleading, they must be accompanied by a disclaimer to communicate to consumers the level of scientific evidence supporting the claim.

Today, the FDA responded to a petition for a new 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 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. 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 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.

Consumers should have access to clear, transparent food labels that enable them to make smart choices that benefit themselves and their families. Our Nutrition Innovation Strategy employs a broad approach to support industry initiatives to introduce products that meet consumer demands for healthier foods.

Key aspects of our new strategy include modernizing and prioritizing new claims on food labels, as well as updating ingredient labels and food standards in an effort to make labels more understandable to consumers. Establishing a framework that encourages industry to invest in and convey to consumers the nutritional attributes of their products can support healthier choices for Americans. Today’s action gets us one step closer to our ultimate goal of improving nutrition and reducing the burden of chronic disease.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.