Getting FDA approval for a qualified health claim

Image of Corn a source of High-Amylose Maize Resistant Starch used by new qualified health claim

The following article is reprinted with permission; and provides an overview of the clinical trial research necessary to make a qualified health claim on front of food package labeling.   Companies needing a competitive edge must conduct rigorous studies to get a qualified health claim approved by the Food and Drug Administration.

High-Amylose Maize Resistant Starch Health Claim Approved for Type 2 Diabetes 

The U.S. Food and Drug Administration (FDA) recently approved a qualified health claim which will enable food companies to include messaging on the packaging of products which contain high-amylose maize resistant starch (HAM-RS). Type 2 diabetes (T2D) is characterized by insulin resistance which, over time, leads to exhaustion of the insulin-producing cells of the pancreas. Substantiation of the qualified health claim was supported by eight clinical trials, one of which was completed by members of the MB Clinical Research team. In this study, overweight and obese participants (11 men and 22 women) were randomly assigned to received either 0 (control), 15, or 30 g/d HAM-RS for four-week periods, separated by a three-week washout. In men, insulin sensitivity increased with daily intake of 15 and 30 g/d HAM-RS, relative to the control (48% and 56%, respectively, p <0.05 for both vs. control). However, there were no significant differences in insulin sensitivity for women, relative to control. The FDA concluded that the totality of the evidence supports the following claims:

“High-amylose maize resistant starch may reduce the risk of Type 2 diabetes. FDA has concluded that there is limited scientific evidence for this claim.”

“High-amylose maize resistant starch, a type of fiber, may reduce the risk of Type 2 diabetes. FDA has concluded that there is limited scientific evidence for this claim.”

Comment: We are hopeful that the approval of this qualified health claim will stimulate more research evaluating the effects of fermentable dietary fibers on carbohydrate metabolism. There is consistent evidence from observational studies that indicate higher consumption of certain fibers, especially cereal fibers, is associated with lower risks for metabolic syndrome and T2D. Research is needed to more clearly define the characteristics of dietary fibers that are associated with these benefits and to elucidate the underlying mechanisms. Based on our work and that of others, we hypothesize the liberation of short-chain fatty acids during fermentation of HAM-RS is a mechanism for enhanced insulin sensitivity. Other mechanisms may be important as well, particularly alterations in the microbiome.

References:

U.S. Food and Drug Administration. RE: Petition for a Health Claim for High-Amylose Maize Starch (Containing Type-2 Resistant Starch) and Reduced Risk Type 2 Diabetes Mellitus (Docket Number FDA-2015-Q-2352-0023), December 12, 2016.

 

Maki KC, Pelkman CL, Finocchiaro ET, Kelley KM, Lawless AL, Schild AL, Rains TM. Resistant starch from high-amylose maize increases insulin sensitivity in overweight and obese men.  J Nutr 2012;142:717-23.

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