The US Food and Drug Administration (FDA) announced on 19 November that it would allow producers of edible oils that contain at least 70% oleic acid to make qualified health claims (QHC) that their products contain cardiovascular benefits when replacing saturated fats.
FDA commissioner Scott Gottlieb said that qualified health claims on food products were allowed when there was not enough evidence for an authorised health claim. However, the claim “must be accompanied by a disclaimer to communicate to consumers the level of scientific evidence supporting the claim”.
Corbion Biotech petitioned for an authorised health claim in 2016 that would have said that daily consumption of a product containing at least 10g of oleic acid per serving reduced the risk of coronary heart disease. After this was rejected by the FDA in 2017, Carbion Biotech then petitioned for the QHC.
“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 1.5 tablespoons (20g) of oils containing high levels of oleic acid may reduce the risk of coronary heart disease,’” Gottlieb said. “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.’”
Oils meeting the standard included high oleic sunflower oil, high oleic safflower oil, high oleic canola oil, olive oil and high algal oil.
Gottlieb said the FDA examined seven small randomised clinical studies of edible oils containing at least 70% oleic acid. In six of them, those assigned the oils had lower low-density lipoprotein (LDL) and total cholesterol than those assigned a Western-style diet higher in saturated fat. The seventh study found no difference.