Resistant Starch Petition for Reduced Risk of Diabetes Health Claim

In March of 2015, Ingredion Incorporated submitted a health claim petition to the U.S. Food and Drug Administration (FDA) that Hi-maize resistant starch, manufactured by Ingredion, helps to reduce the risk of type 2 diabetes.  This is huge news, as only the most serious and best scientific evidence supports health claim petitions.

Resistant starch reduces the risk of type 2 diabetes
FDA evaluating health claim petition that resistant starch helps to reduce the risk of type 2 diabetes

As you would expect, foods cannot make claims that they reduce the risk of a disease unless it has been pre-approved by the U.S. FDA.  If it is approved, it would allow foods containing Hi-maize resistant starch to add to their labels that the food reduces the risk of type 2 diabetes.

You are probably most familiar with health claims that certain foods reduce the risk of heart disease. For instance, beta-glucan (a soluble dietary fiber) from oats and psyllium reduce the risk of heart disease because they lower cholesterol levels. Soy protein also has an approved claim that it reduces the risk of heart disease because it also lowers cholesterol. Reducing cholesterol is a recognized biomarker for reducing heart disease.

Insulin resistance is a recognized biomarker for type 2 diabetes. According to a fact sheet from National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) – “Insulin resistance increases the risk of developing type 2 diabetes and prediabetes. Prediabetes usually occurs in people who already have insulin resistance. Although insulin resistance alone does not cause type 2 diabetes, it often sets the stage for the disease by placing a high demand on the insulin-producing beta cells…Studies have shown that most people with prediabetes develop type 2 diabetes within 10 years, unless they change their lifestyle.”

Resistant starch improves insulin sensitivity (and reduces insulin resistance) independent of losing weight and exercise, the two lifestyle changes recommended by public health authorities. Thus, it would be another tool to help people improve their insulin sensitivity and reduce their risk of developing type 2 diabetes.

The FDA has asked for public comments on this petition.  Interested people can submit comments until September 7, 2015 at www.regulations.gov. The Docket number for the petition is FDA- 2015-Q-2352.  The Docket folder is linked here.  A final decision from the FDA should be announced in mid-February 2016.

Perhaps claims on foods and food products that they can reduce the risk of type 2 diabetes will be just as common as claims that foods reduce the risk of heart disease in the not too distant future!

 

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