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FDA Approves New Qualified Health Claim for Oils High in Oleic Acid
That Cut Risk of Coronary Heart Disease

The FDA has determined that there's credible evidence to support a qualified health claim that consuming oleic acid in edible oils, such as olive oil, sunflower oil, safflower oil, canola oil, or soybean oil, may reduce the risk of coronary heart disease.

After conducting a systematic review of the available scientific evidence, the FDA now intends to exercise enforcement discretion over the use of two qualified health claims characterizing the relationship between consumption of oleic acid in edible oils (containing at least 70% of oleic acid per serving) and reduced risk of coronary heart disease. Oleic acid is a monounsaturated fat which, when substituted for fats and oils higher in saturated fat, may reduce the risk of coronary heart disease.

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% per serving) and improved cholesterol levels, which indicates a reduced risk of 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 LDL cholesterol levels compared with 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.

The FDA intends to exercise enforcement discretion for the following qualified health claims:

"Supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, when replaced for fats and oils higher in saturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, oleic acid-containing oils should not increase the total number of calories you eat in a day. One serving of [x] oil provides [x] grams of oleic acid (which is [x] grams of monounsaturated fatty acid)."

"Supportive but not conclusive scientific evidence suggests that daily consumption of about 1 1/2 tablespoons (20 grams) of oils containing high levels of oleic acid may reduce the risk of coronary heart disease. To achieve this possible benefit, oleic acid-containing oils should replace fats and oils higher in saturated fat and not increase the total number of calories you eat in a day. One serving of [x] oil provides [x] grams of oleic acid (which is [x] grams of monounsaturated fatty acid)."

The qualified health claims respond to a petition filed by Corbion Biotech, Inc. Qualified health claims are supported by credible scientific evidence, but don't meet the more rigorous "significant scientific agreement" standard required for an authorized FDA health claim. As such, they must be accompanied by a disclaimer or other qualifying language so that the level of scientific evidence supporting the claim is accurately communicated. The FDA's intent to exercise enforcement discretion for the use of the qualified health claims means that the agency doesn't intend to object to its use, as long as the products bearing the claim are consistent with the factors FDA stated in the Letter of Enforcement Discretion that responds to the petition.

Oleic acid can be found naturally in numerous food sources, including edible oils, meat (such as beef, chicken, and pork), cheese, nuts, sunflower seeds, eggs, pasta, milk, olives, and avocados. Corbion Biotech's petition identified the following edible oils that contain at least 70% of oleic acid per serving: 1) high oleic sunflower oil, 2) high oleic safflower oil, 3) high oleic canola oil, 4) olive oil, and 5) high oleic algal oil.

— Source: FDA
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