FDA News

FDA allows qualified health claims for CV benefits of certain edible oils

The FDA announced that it will allow manufacturers of edible oils containing at least 70% oleic acid to make qualified health claims that their products have CV benefits when replacing saturated fats.

According to a statement from FDA Commissioner Scott Gottlieb, MD, qualified health claims on food products are allowed when there is not enough evidence for an authorized health claim, but a claim is supported by limited scientific evidence. The claim “must be accompanied by a disclaimer to communicate to consumers the level of scientific evidence supporting the claim,” he said.

According to a document released by the FDA, Corbion Biotech in 2016 petitioned for an authorized health claim that would have stated that daily consumption of edible oil with at least 10 g of oleic acid per serving reduces risk for CHD. The FDA rejected the petition in 2017, after which the company petitioned for the qualified health claim.

“The current evidence supports a qualified health claim concerning the relationship between oleic acid in edible oils and a reduced risk of CHD,” the agency wrote in the response to the petition.

“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 (20 grams) of oils containing high levels of oleic acid, may reduce the risk of coronary heart disease,’” Gottlieb said in the statement. “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.’”

He said oils that meet the standard include high oleic sunflower oil, high oleic safflower oil, high oleic canola oil, olive oil and high oleic algal oil.

Gottlieb said the FDA examined seven small randomized clinical studies of edible oils containing at least 70% oleic acid, and in six of them, those assigned the oils had lower LDL and total cholesterol than those assigned a Western-style diet higher in saturated fat. The seventh study found no difference between the groups.

“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,” he said.

Disclosure: Gottlieb is an employee of the FDA.

The FDA announced that it will allow manufacturers of edible oils containing at least 70% oleic acid to make qualified health claims that their products have CV benefits when replacing saturated fats.

According to a statement from FDA Commissioner Scott Gottlieb, MD, qualified health claims on food products are allowed when there is not enough evidence for an authorized health claim, but a claim is supported by limited scientific evidence. The claim “must be accompanied by a disclaimer to communicate to consumers the level of scientific evidence supporting the claim,” he said.

According to a document released by the FDA, Corbion Biotech in 2016 petitioned for an authorized health claim that would have stated that daily consumption of edible oil with at least 10 g of oleic acid per serving reduces risk for CHD. The FDA rejected the petition in 2017, after which the company petitioned for the qualified health claim.

“The current evidence supports a qualified health claim concerning the relationship between oleic acid in edible oils and a reduced risk of CHD,” the agency wrote in the response to the petition.

“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 (20 grams) of oils containing high levels of oleic acid, may reduce the risk of coronary heart disease,’” Gottlieb said in the statement. “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.’”

He said oils that meet the standard include high oleic sunflower oil, high oleic safflower oil, high oleic canola oil, olive oil and high oleic algal oil.

Gottlieb said the FDA examined seven small randomized clinical studies of edible oils containing at least 70% oleic acid, and in six of them, those assigned the oils had lower LDL and total cholesterol than those assigned a Western-style diet higher in saturated fat. The seventh study found no difference between the groups.

“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,” he said.

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Disclosure: Gottlieb is an employee of the FDA.