Oleic acid CHD claims success: US FDA approves qualified claim petition on high level foods 

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20 Nov 2018 --- The US Food and Drug Administration (FDA) has responded positively to a petition for a new qualified health claim for edible oils containing oleic acid. As a result, products with an oleic acid content upward of 70 percent, such as certain olive, canola and sunflower oils, can be labeled as carrying cardiovascular benefits, but only when replacing heart-damaging saturated fat.

The FDA recognizes two kinds of health claims on food product packages: authorized health claims and qualified health claims. As noted by FDA Commissioner Scott Gottlieb in a statement released yesterday, an authorized health claim meets the more rigorous standard of “significant scientific agreement.” 

As is the case with oleic acid and heart health benefits, a qualified health claim means scientific evidence is more limited. To ensure qualified claims are not misleading to consumers, the agency stipulates that these must include a disclaimer to communicate to consumers the level of scientific evidence supporting the claim.

Manufacturers of high oleic acid oils can choose to include a qualified health claim on their label that reads “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.” 

Manufacturers will, however, have to make it clear that these oils “should replace fats and oils higher in saturated fat and not increase the total number of calories you eat in a day” to achieve this cardiovascular health benefits,

Oleic acid can be found naturally in a range of food sources, including edible oils, meat, cheese, nuts, sunflower seeds, eggs, pasta, milk, olives and avocados. 

The FDA decision on the qualified health claims respond to a petition filed in 2016 by Corbion Biotech, Inc. (known at the time of the filing as TerraVia). In its petition, the company identified the following edible oils that contain at least 70 percent of oleic acid per serving: 
1) High oleic sunflower oil;
2) Hgh oleic safflower oil; 
3) High oleic canola oil; 
4) Olive oil, and; 
5) High oleic algal oil.

Although the science behind the new qualified health claim for oleic acid is not conclusive, the FDA notes that it is “promising.” 

The decision was based on the results of seven small clinical studies that evaluated the relationship between the consumption of oils containing high levels of oleic acid (at least 70 percent per serving) and improved cholesterol levels, which indicates a reduced risk for coronary heart disease. 

Of those seven studies, six reportedly showed that study participants 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 low-density lipoprotein (LDL) cholesterol levels. This compared to 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. This was unless they replaced other types of fats and oils that were higher in saturated fats in the diet.

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With over 80 years of fermentation expertise and the use of natural raw materials to produce exceptional food and beverage ingredients, Corbion has a wealth of expertise in the world of biobased food ingredients. Our extensive portfolio combined with leading expertise, application knowledge and technical service make us your food industry partner, helping solve food integrity issues by providing improvements in shelf life, freshness and food safety.

Leading expertise
Our expertise in food is based on our knowledge of microbiology, fermentation, and application of lactic acid and lactates. Throughout our history, we have grown with our customers to become a mature, reliable partner in technology and product development. Our knowledge of microbiology is currently also being applied to extend the shelf life and safety of your food products through innovative preservation solutions

Superior quality
Through an extensive portfolio of high quality products, Corbion provides exciting, naturally-derived options in preservation, shelf life extension, flavoring, acidification and fortification. Using nature’s best ingredients, we formulate unique propositions that can perfect your food products and help save on your own R&D.

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Our global presence, puts us right by your side, wherever you are in the world. With established R&D and production facilities in every continent, our technical expertise, advice and products are available worldwide. Together with Corbion's large, global R&D team, our clients drive our innovation and play an integral role in the development of new solutions.


• Natural preservation solutions
• Shelf life extension
• Clean label solutions
• Food safety solutions
• Sodium reduction solutions
• Mineral Fortification

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