FDA Completes Review of Qualified Health Claim Petition for Oleic Acid and the Risk of Coronary Heart Disease

FDA Completes Review of Qualified Health Claim Petition for Oleic Acid and the Risk of Coronary Heart

November 19, 2018

The U.S. Food and Drug Administration (FDA) has determined that there is credible evidence to support a qualified health claim that consuming oleic acid in edible oils, such as olive oil, sunflower oil, or canola 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 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 1½ 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 do not 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 does not 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.

For More Information

• FDA Response to Petition for a Qualified Health Claim for Oleic Acid in Edible Oils and Reduced Risk of Coronary Heart Disease
• Statement from FDA Commissioner Scott Gottlieb, M.D.
• Questions and Answers on Health Claims in Food Labeling
• Qualified Health Claims: Letters of Enforcement Discretion
• Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims