The agency is now reviewing the petition and a final decision could come in early 2016.
Photo © iStockphoto.com/ travellinglight
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.”
Also read:
Who Is the Blood Sugar-Management Dietary Supplement Customer?
Jennifer Grebow
Editor-in-Chief
Nutritional Outlook magazine
jennifer.grebow@ubm.com
Senate Committee has released the text of 2024 Farm Bill, with changes to hemp regulations
November 19th 2024The U.S. Senate Committee on Agriculture, Nutrition, & Forestry has introduced the Rural Prosperity and Food Security Act, which will serve as the Senate’s draft for the 2024 Farm Bill.
NPA’s lawsuit against FDA on NMN stayed pending agency’s decision on citizen petition
November 6th 2024The court has granted a joint motion for stay filed by NPA and FDA, pending the agency's decision on the citizen petition asking FDA to reverse its stance on NMN's status as a dietary ingredient.