Following its acceptance by the FDA on July 8, 2015 and a public comment period, the petition is now under review as a qualified health claim. A final decision is expected in the first quarter of 2016 or later.
“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 at 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 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, said the company in a release.
Qualified health claims
If the petition is successful, the claim would have to carry a qualification similar to that which accompanies P&G’s successful psyllium husk claim. The FDA allows for the following claim statements to be made:
Psyllium husk may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very little scientific evidence for this claim.
Psyllium husk may reduce the risk of type 2 diabetes. FDA has concluded that there is very little scientific evidence for this claim.
The statements regarding the FDA’s conclusion of “very little evidence for the claim” has led to some industry observers to question the value of qualified health claims.
However, Lorraine Niba, PhD, MBA: Global Director, Nutrition Innovation for Ingredion, told us that some of the most successful nutritional ingredients have qualified health claims, and noted that omega-3s saw a substantial growth in the market when they obtained a qualified health claim.
“There are only very few ingredients that have an SSA claim, typically ingredients that have an extensive body of clinical and epidemiological evidence over several years of being in the food supply,” she said. “We do not believe that the disclaimers detract from the value of the claim; they in fact serve a purpose in informing and educating the consumer about the nature of claims.”
“Glycemic health and diabetes prevention are leading concerns for US consumers today,” added Dr Niba. “While Ingredion cannot comment on the use of claims by other ingredient manufacturers, consumer trend surveys indicate sustained interest in foods and ingredients that help reduce the risk of type 2 diabetes.”