FDA approves qualified health claim for high-amylose resistant starch and reduced risk of type 2 diabetes

By Elaine Watson contact

- Last updated on GMT

Picture credit: Dr Mark Hyman
Picture credit: Dr Mark Hyman
News that the US Food and Drug Administration (FDA) has approved a qualified health claim about high amylose maize resistant starch as a weapon in the fight against type 2 diabetes will start a much-needed conversation about the fiber, say experts.

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.

The fact that a regulatory agency has looked at this will increase the confidence of food companies to talk about resistant starch

The claim (spelled out in a Dec 12 letter​ to Ingredion) is only permitted on foods that contain 10%+ of the daily value for vitamin A, C, iron, protein and fiber, plus 10% of the DV for vitamin D or​ potassium per reference amount customarily consumed (RACC).

It reads: "High-amylose maize resistant starch may reduce the risk of type 2 diabetes, although FDA has concluded that there is limited scientific evidence for this claim."​ 

While this might not sound like a ringing endorsement, it reflects substantial progress, said Rhonda Witwer, an expert in resistant starch who worked at Ingredion for more than a decade before setting up the consultancy Witwer Works.

“This is the highest claim achieved for a dietary ingredient or food reducing the risk of type 2 diabetes,” ​she told FoodNavigator-USA. “Yes, the wording isn’t great, but this is a Level C qualified health claim, whereas whole grains and psyllium [which are also claimed to reduce the risk of type 2 diabetes], were classified as Level D.

“I’m not sure whether food manufacturers will want to put this claim on their labels ​[talking about medical conditions such as diabetes on food labels can be a bit of a buzzkill, she said], but the fact that a regulatory agency has now looked at this will increase the confidence of food companies to talk about resistant starch and I am hoping will encourage the U.S. National Institutes of Health and other funders of large clinical studies to continue this valuable research.

Lorraine Niba, PhD, global director, nutrition innovation at Ingredion added: "This is victory without a doubt; we've systematically built a body of science around Hi-maize 260 glycemic and insulin health benefits, and went through a rigorous process of preparing and filing a comprehensive petition with the US FDA to obtain the Qualified Health Claim."

What is high-amylose resistant starch?

HI-MAIZE 260 resistant starch​ is a Non-GMO Project verified fiber (derived from proprietary high amylose corn hybrids produced through traditional plant breeding) that resists digestion in the small intestine but is fermented in the large intestine, and has been shown to increase insulin sensitivity, helping prediabetics better control their blood glucose.

It has also demonstrated prebiotic effects as it resists digestion in the small intestine and promotes the growth of beneficial bacteria in the large intestine, and can be incorporated into breads, pancakes, bars, baked goods, snacks and pasta, replacing up to 20% of flour without impacting taste, texture, color or processing, claims Ingredion.

HI-MAIZE 260, which has a white color and a bland flavor, contains approximately 60% resistant starch, which is not digested in the small intestine and acts as a dietary fiber, and 40% slowly-digestible starch, which helps provide sustained energy. Because it retains its natural granule structure, it is classified as a Type 2 Resistant Starch (RS2).

Only Ingredion’s Hi-Maize currently meets the criteria for the claim

The US claim will be restricted to products using high-amylose maize starch containing at least 50% resistant starch that is unmodified and has only been subject to conventional milling processes (right now only Ingredion’s HI-MAIZE 260 product – a specific kind of starch manufactured from the HYLON VII variety of high-amylose corn – meets this definition, although others could in future).

It follows a citizen’s petition​ submitted by Ingredion in March 2015, which cited clinical studies demonstrating that HI-MAIZE 260 increases insulin sensitivity in people with prediabetes, and thus helps them manage their blood glucose.

In Europe, food manufacturers are permitted to use the claim, “Replacing digestible starch with resistant starch induces a lower blood glucose rise after a meal.​”

To read EFSA’s 2011 evaluation of the claim, and the conditions of use, click HERE.

The higher your insulin resistance the better you’ll respond

The studies – which the FDA found to be inconsistent in nature with different dosage levels, endpoints/biomarkers and populations – demonstrated strong effects on subjects with prediabetes, but not those with normal blood sugar control, said Witwer.

The higher your insulin resistance the better you’ll respond, so the closer you are to being diabetic, the more dramatic improvements you can expect.”

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