Will a qualified health claim for soybean oil give it a new lease of life?

By Elaine Watson contact

- Last updated on GMT

Picture: United Soybean Board
Picture: United Soybean Board
Just days after approving a qualified health claim extolling the heart-healthy benefits of macadamia nuts, the FDA has approved a similar claim about soybean oil in a move petitioner Bunge says will provide clarity for consumers bombarded with confusing messages about which fats are healthy.

“Consumers are getting bombarded with different messaging about oils and fats every day and it can get very confusing, and they are questioning whether the information is accurate or not, when it comes to their health," ​said Mark Stavro, Ph.D, global marketing director at Bunge (a leading oils producer, which filed a petition with the FDA in February 2016).

So to have an authoritative source [the FDA] review the evidence and conclude that soybean oil – which is widely available and affordable, but has seen its market share eroded a little as sexier, and far more expensive, oils such as coconut and avocado gain momentum – is a heart-healthy oil, is a huge boost,  added Dr Stavro, who said that volumes of soybean oil at retail had been "relatively flat​" at retail over the past five years.

“We’re not talking about an obscure food here, and this gives marketers and packaged food companies a lot of opportunities to generate excitement around soybean oil and vegetable oil​ [as soybean oil is often described as on pack]," he told FoodNavigator-USA.

While the wording of the claim is long, food marketers could use a heart image and simple wording such as ‘heart healthy’ on front of pack and then alert readers to the FDA-approved qualified health claim on the back, noted Richard Black, principal at Quadrant D Consulting, and former VP of global nutrition science at PepsiCo.

"I am not sure that this will stimulate mass switching ​[from other oils to soy] but what I think it will do is reduce barriers to purchasing soy, which some consumers still shy away from because they have concerns about phytoestrogens ​[although soybean oil does not have the phytoestrogen content of other soy foods]," said Black.

At the very least it will give people something new and positive to say about an oil that most people don't really think about when it comes to health benefits, given all the noise around olive oil, and some of the newer oils gaining traction (avocado, coconut), he predicted. 

Total fat and saturated fat

In a July 21 letter​ to Bunge, the FDA said that while soybean oil is not low in total fat, which can exclude products from making health claims, it is willing to overlook this, as it has in the past with other oils and nuts, given their health benefits.

When it comes to saturated fats, meanwhile, the FDA concluded that soybean products don’t have to meet the criteria for ‘low saturated fat’ to make the health claim, but said eligible products must nevertheless “meet certain elements of the saturated fat disqualifying criteria in 21 CFR 101.14(a)(4)​… to ensure that foods bearing the claim will not contain excessive amounts of saturated fatty acids.”

(Read the section of the FDA letter​ entitled 'Saturated fat disqualifying level' to learn the criteria as regards saturated fat.)

‘Supportive but not conclusive evidence…’

So what does the wording look like?

As with the recent macadamia nut claim,​ it’s pretty lengthy and caveat-laden:

“Supportive but not conclusive scientific evidence suggests that eating about 1 ½ tablespoons (20.5 grams) daily of soybean oil, which contains unsaturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, soybean oil is to replace saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of soybean oil.”


“Supportive but not conclusive scientific evidence suggests that eating about 1 ½ tablespoons (20.5 grams) daily of soybean oil, which contains unsaturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, soybean oil is not to increase the amount of saturated fat in the diet or the total number of calories you eat in a day. One serving of this product contains [x] grams of soybean oil.”

However, ‘supportive but not conclusive’ is arguably more compelling than ‘limited and not conclusive’ - terms the FDA permits on similar qualified health claims about canola oil​ and olive oil ​and reduced risk of heart disease - Bunge's Dr Stavro observed.

The wording is also considerably stronger than many other qualified health claims,​ which are so qualified that some manufacturers have been reluctant to use them on food labels at all (the qualified claim re. whole grains and type 2 diabetes, for example, says that, ‘FDA has concluded that there is very limited scientific evidence for this claim’).

This was a ‘B’ level claim​ [FDA ranks qualified health claims from A to D, A representing the strongest claims and D the weaker ones based on the evidence], so we’re pretty happy​,” added Dr Stavro.

What are qualified health claims?


Qualified health claims enable food marketers to talk about a relationship between a substance and disease where the supporting science fails to meet the FDA’s ‘significant scientific agreement’ standard, so they are typically ‘qualified’ in such a way as to not mislead consumers.

While the qualification typically comes in the form of a far-from-consumer-friendly disclaimer, many observers believe the claims are still better than nothing.

Does this reflect a change in FDA’s thinking on saturated fat? Not really, says Bunge

Asked whether this claim coupled with the just-approved macadamia nut claim reflect a recent change in FDA thinking about saturated fat, Dr Stavro said he didn’t think so, given that FDA allowed a qualified health claim on olive oil (which, like soybean oil, doesn’t meet the criteria for ‘low fat’ or ‘low saturated fat’ claims) way back in 2004.

He added: “I think this aligns with what the 2015 Dietary Guidelines say," ​in which consumers are advised to​ use 'vegetable oil in place of solid fats [such as] butter, stick margarine, shortening, lard, and coconut oil.'

“I think what the FDA is saying is that in studies where soybean oil – which is high in poly- and mono unsaturated fat and has around 15% saturated fat – displaces fats such as palm oil that are higher in saturated fat, you see a significant reduction in LDL cholesterol, which is a risk factor for coronary heart disease.”

Related topics: Regulation

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