The agency is now reviewing the petition and a final decision could come in early 2016.
Numerous studies back the ability of Hi-Maize, a brand of digestion-resistant starch, to help minimize blood sugar spikes and aid insulin function. Now, Hi-Maize’s supplier Ingredion Inc. (Westchester, IL) is seeking an FDA health claim linking this resistant starch from high-amylose corn with reduced risk of developing type 2 diabetes.
The company reports that FDA accepted its health claim petition in July. After undergoing a comment period, the agency is now reviewing the petition and a final decision could come in early 2016.
Ingredion points out that more than 70 human clinical trials have been conducted on high-amylose resistant starch, including studies both independent and funded by the company itself. At least eight well-controlled studies show that Hi-maize “improved insulin sensitivity or other biomarkers accepted by the FDA as evidence for reduced risk of type 2 diabetes,” the company says.
“We believe that there is consistent scientific evidence showing a clear link between consumption of resistant starch from high-amylose corn and reduction of risk for type 2 diabetes,” said Christine Pelkman, PhD, senior nutrition scientist and clinical research manager, Ingredion, in a press release. She added that the outside scientific and regulatory consultants the company collaborated with agreed that the scientific portfolio behind the ingredient is strong and “that these findings provide a strong basis for a health claim petition.”
Nutritional Outlook magazine