ConAgra to FDA: There is ‘ample evidence’ to support qualified health claim on whole grains and type II diabetes

In a petition ​to the Food and Drug Administration (FDA) submitted on January 25, Dr Mark Andon, Vice President Nutrition, Research, Quality, and Innovation at ConAgra Foods, said: “We believe there is consistent scientific evidence to suggest an inverse relationship of whole grain consumption and the incidence of DMT2 (diabetes mellitus type 2).”​

He added: “Dietary strategies that incorporate increased consumption of whole grains and whole grain products are likely to have a significant and substantially positive public health outcome to the US consumer.”​

The proposed claims​

ConAgra proposes the following two model claims:

‘Scientific evidence suggests, but does not prove, that diets low in saturated fat and cholesterol that include three servings (48 grams) of whole grains per day may reduce the risk of diabetes mellitus type 2.​

‘Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 grams per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2.’​

The science: Observational data and controlled trials​

Multiple observational studies supported an inverse association between whole grains consumption and DMT2 incidence, while several randomized controlled trials (RCTS) showed whole grain consumption reduced fasting blood glucose concentrations and insulin resistance, said Dr Andon.

“Thus, the large epidemiological studies that showed reduced incidence of DMT2 agreed conceptually with the randomized, controlled studies of DMT2 surrogate measures (reduced glucose and/or insulin) when whole grains were consumed daily.”​

He also noted that in the absence of large, long-term RCTs with type II diabetes as the endpoint (which would be impractical for food based interventions), the FDA has itself identified surrogate endpoints for identifying risk reduction including fasting blood glucose concentrations, oral glucose tolerance tests and measures of insulin resistance.

2010 Dietary Guidelines for Americans​

The 2010 Dietary Guidelines for Americans recommend that Americans make half or more of their grains whole grains (three to five servings of whole grains a day).

They also state: "Limited evidence also shows that consuming whole grains is associated with a reduced incidence of type II diabetes.”​

Whole grains and health claims​

Currently there are two approved health claims about whole grains:

‘Diets rich in whole grain foods and other plant foods and low in fat, saturated fat, and cholesterol, may help reduce the risk of heart disease and certain cancers.’ (1999)​

‘Diets rich in whole grain foods and other plant foods, and low in saturated fat and cholesterol, may help reduce the risk of heart disease.’ (2003)​

To qualify, foods must contain a minimum of 51% (by weight) whole grains. 

Whole Grains Council: We’re delighted  ​

Cynthia Harriman, director of food and nutrition strategies at Oldways / The Whole Grains Council, told FoodNavigator-USA she was “delighted​” by ConAgra’s petition.

“This is very good news for the industry... It's even better news for consumers, as this claim, if successful, will promote better public health.​

“ConAgra has carefully divided out the clinical evidence and the epidemiological evidence...  It has also carefully distinguished between studies that use FDA's definition of whole grain (all of the bran, germ, and endosperm) and those with an expanded definition that also includes extra bran and/or germ."​​

This petition is very well put together​

She added: “I think the petition is very well put together. By requiring foods to have 12g or more of whole grain per RACC, this proposed claim is fairer and more even-handed to different types of foods​ [than the authorized claims above].”

“We especially appreciate that ConAgra’s proposed claim offers a more level playing field for different products. The 1999 whole grain heart health claim, because it defines a food as whole grain if it contains 51% of its weight as whole grain, discriminates against products with a high water weight.​

“Bread, for instance, is normally about 40% water weight, so of the remaining non-water ingredients, 51/60 must be whole grain. Whereas crackers, breakfast cereals, and other dry foods can more easily incorporate 51% of their weight as whole grains.”​

So how does she rate ConAgra’s chances?

“Success can be hard to predict with FDA," ​she said.

"[However] as witnessed by its Study on Whole Grain Labeling​ that's in the planning stages, it is interested in the topic of clearer labeling of whole grain  products, so this should be a plus.”​

The timeline​

The petition is now open to comments (docket # FDA-2012-Q-0242) until May 11. The FDA must then respond formally by October 23, 2012.

What are qualified health claims?​

Qualified health claims have been permitted in the US since the 1999 Pearson v. Shalala case (brought against the FDA by Jonathan Emord on behalf of Durk Pearson and Sandy Shaw), which validated them as a First Amendment freedom of speech right.

The claims enable firms to talk about a relationship between a substance and disease where the supporting science fails to meet the FDA’s ‘significant scientific agreement’ standard, but is ‘qualified’ in such a way as to not mislead consumers.

While the qualification comes in the form of a far-from-consumer-friendly disclaimer, many observers believe the claims are still better than nothing.