FDA supports claim that oleic acid reduces risk of CVD

The FDA is backing a new “qualified health claim” that oils high in oleic acid can help improve cholesterol levels and protect against coronary heart disease, Commissioner Scott Gottlieb, MD, announced Nov. 19.

In his statement, Gottlieb was careful to point out this new claim, which manufacturers will now have the choice of including in their packaging, is a qualified claim, not an authorized one. While authorized claims need to meet a rigorous standard of significant scientific agreement, qualified claims are supported by a decidedly more limited base of evidence.

“The science behind the new qualified health claim for oleic acid, while not conclusive, is promising,” Gottlieb said.

Oleic acid, a monounsaturated fat that’s been shown to have cardiovascular benefits when replacing damaging saturated fats, can be consumed orally as a percentage of another edible oil, like canola, olive, algal or sunflower oil. FDA standards require oils to contain at least 70 percent oleic acid to meet criteria for the new claim.

Gottlieb said before confirming the claim, the FDA assessed results from seven small clinical studies that concluded patients who consumed oleic acid saw lower cholesterol levels, indicating a reduced risk for coronary heart disease. Six studies found individuals who replaced their traditional diets with ones higher in oleic acid experienced a “modest lowering” in their total cholesterol and LDL cholesterol compared to people who stuck to a more Western diet.

“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,” Gottlieb wrote.

The commissioner said overhauling the U.S.’s approach to food labeling is one of the primary goals of the FDA’s Nutrition Innovation Strategy, which was announced in March. He said his team plans to modernize and prioritize new claims on food labels, as well as update existing packaging.

“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,” Gottlieb said. “Today’s action gets us one step closer to our ultimate goal of improving nutrition and reducing the burden of chronic disease.”