Ingredion submits health claim petition to FDA for resistant starch

Ingredion Inc., Westchester, Ill., said it submitted a health claim petition to the FDA for high-amylose corn resistant starch and reduction of risk for type 2 diabetes. Clinical studies conducted by academic institutions and research organizations on high-amylose corn resistant starch type 2 (RS2) over the years have generated considerable scientific data supporting the health benefits of this ingredient.

“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, Ph.D., senior nutrition scientist and clinical research manager with Ingredion. "Ingredion collaborated with external scientific and regulatory experts, who indicated that these findings provide a strong basis for a health claim petition for reducing the risk for this disease."

Eight well-controlled clinical trials showed that HI-MAIZE resistant starch from high-amylose corn improved insulin sensitivity or other biomarkers accepted by the FDA as evidence for reduced risk for type 2 diabetes, Ingredion stated.

“Given current trends for type 2 diabetes rates and with nearly 80 million Americans at risk, we believe that ingredients such as HI-MAIZE resistant starch can be important contributors in the fight against this disease," added Lorraine Niba, Ph.D., global director, nutrition for Ingredion. "Diets that incorporate increased consumption of resistant starch from high-amylose corn can have a substantial positive health impact on the American population. HI-MAIZE resistant starch can help food manufacturers and formulators create innovative, healthier products that address one of the leading health concerns of consumers in the U.S.”

FDA performed an initial review of the petition and accepted it for filing on July 8. After going through a public comment period, the petition is now under review as a qualified health claim, Ingredion said. A final decision is expected in the first quarter of 2016 or later.

HI-MAIZE resistant starch is a type of dietary fiber derived from a variety of corn that is high in amylose starch. This type of starch is resistant to digestion and acts like fiber in the human digestive tract, Ingredion said. It is a white powder with a mild taste that is easily incorporated into everyday foods such as pasta, smoothies, bread, muffins and other baked goods.