January 2014 Issue

Whole Grains–Type 2 Diabetes Health Claim — What Your Colleagues Think About It and the Reasons Behind the Decision
By Densie Webb, PhD, RD
Today’s Dietitian
Vol. 16 No. 1 P. 10

The recent headlines announcing the FDA’s approval of a qualified health claim that links whole grain consumption to a decreased risk of developing type 2 diabetes seemed, at first glance, to be a major announcement and a progressive move for improving Americans’ health. Companies finally could communicate that whole grains and foods containing whole grains that meet nutrient requirements outlined by the FDA may lower the risk of type 2 diabetes.

But there’s more to this story than what meets the eye.

Requirements
The FDA requires that a petition be filed for each potential health claim so the agency can weigh the available evidence. In this case, ConAgra Foods, the maker of the first 100% white whole wheat flour, filed a petition with the agency in January 2012 seeking approval of one or both of the following health claims to be used on packages of whole grain foods:

• “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 FDA approved the following wording options:

• “Whole grains may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very limited scientific evidence for this claim.”

• “Whole grains may reduce the risk of type 2 diabetes. FDA has concluded that there is very limited scientific evidence for this claim.”

As one of the largest grain-milling companies in the world, ConAgra sells Ultragrain to other companies who will be able to use the health claim on their products that contain this ingredient.

ConAgra is putting a positive spin on the FDA’s decision, despite the fact that the approved claim clearly states that the FDA didn’t believe there was sufficient evidence linking whole grain consumption and the prevention of type 2 diabetes. “It’s the first health claim pertaining to diabetes and food. That’s a landmark in my mind,” says Mark Andon, PhD, ConAgra’s executive vice president of nutrition. He says the FDA ruled that there was no need to put the claim in the context of the whole diet, such as “as part of a diet low in saturated fat.” The claim for whole grains and type 2 diabetes stands on its own, he says.

While Andon considers the approved health claim to be a landmark event, some dietitians believe the claim isn’t strong enough. “[The health claim] is so qualified, it seems silly to even use it,” says Hillary Wright, MEd, RD, LDN, director of nutrition for the Domar Center for Mind Body Health in Waltham, Massachusetts, and author of The Prediabetes Diet Plan: How to Reverse Prediabetes and Prevent Diabetes Through Healthy Eating and Exercise.

“Most statements used on packaging are strong,” says Cynthia Harriman, director of food and nutrition strategies for Oldways and the Whole Grains Council. “We don’t expect to see the use of statements like, ‘May be just a little lower in calories’ or ‘probably tastes OK, but we’re not sure.’ It’s really too bad the claim is so watered down because, of course, we think diabetics would be better off eating whole grains.”

Jill Weisenberger, MS, RD, CDE, a nutrition and diabetes consultant and author of Diabetes Weight Loss — Week by Week, agrees: “I applaud the FDA for stating that the data are limited. However, if the data are so limited, I’d rather see no health claim at all. Why confuse the public or give them reason to doubt the validity of other health claims?”

Health Claim Basics
To understand how such a health claim emerged, dietitians must first understand how the FDA approves and ranks health claims. With the passing of the Nutrition Labeling and Education Act of 1990, the FDA required health claims to pass its scrutiny. Some health claims, such as those for oat bran, almonds, psyllium, soy protein, plant sterol and stanol esters, and barley fiber, meet the criteria for the FDA’s highest standards of evidence. Most of these approved health claims relate to a food or a food component’s ability to reduce the risk of cardiovascular disease.

Petitioned health claims that have some evidence, but not enough to qualify for a full-fledged health claim, are dubbed “qualified health claims.” The FDA ranks the available evidence for petitioned claims as “high,” “moderate/good,” “low,” and “lowest.”

With this latest health claim for whole grains, the FDA enters new territory because it has approved a qualified health claim for whole grains and the prevention of type 2 diabetes. But the agency approved the health claim with the lowest rank of evidence, classifying it as “very limited.”

“Anyone familiar with the regulatory process will realize that ‘limited evidence’ can mean any one of three things: a small number of good studies, studies of weak design, and/or studies with inconsistent results,” Harriman says. “However, most consumers would probably scratch their heads and wonder why this statement was being used at all.”

At this stage, it’s unknown whether food companies will even want to display the whole grains health claim, given the tenuous nature of the wording. “Only time will tell when and where the claim will be used on consumer products,” Andon says.

Whole Grains Evidence
When evaluating evidence for health claims, the FDA considers well-controlled clinical trials to be the gold standard for approval. For the whole grains and type 2 diabetes petition, the agency reviewed six such trials but found no significant association between whole grain consumption and fasting blood glucose or insulin resistance in five other studies. Most of the research on whole grains and type 2 diabetes has been observational in nature (ie, studies of populations, what they eat, and the incidence of disease). Of the 41 observational studies the FDA evaluated, the agency concluded that it couldn’t draw any conclusions for 38 because of inconsistencies in the way whole grains were defined and identified. Establishing an association between health and the consumption of any type of food is possible only if the food is clearly described and can be easily identified.

Overall, the FDA determined that only three observational studies and one intervention study supported an association between whole grains and a reduced risk of type 2 diabetes, while the others either found no association or provided inadequate definitions of the whole grain foods consumed in the study population.

However, after the FDA’s assessment, a systematic review and meta-analysis of whole grains and type 2 diabetes was published online in October 2013 in the European Journal of Epidemiology, which concluded that “our results support public health recommendations to replace refined grains with whole grains and suggest that at least two servings of whole grains per day should be consumed to reduce type 2 diabetes risk.”

Advice About Whole Grains Hasn’t Changed
Despite the FDA’s disapproval of a definitive health claim, the final word isn’t in on whether eating more whole grain foods can lower the risk of type 2 diabetes. The whole grain industry is working on developing a uniform definition for what constitutes a whole grain that, once developed and accepted, will serve as a universal benchmark for research. This should boost the integrity of studies designed to identify whether an association actually exists between whole grain consumption and a decreased risk of type 2 diabetes as well as other diseases and conditions. “The new health claim leaves the door open for it to be upgraded in the future as more data are accumulated,” Andon says.

Until then, there are other reasons clients and patients should be encouraged to consume whole grains. “I recommend whole grains to all of my patients, whether they’re at risk for type 2 diabetes or not,” Weisenberger says. “Whole grains are underconsumed yet provide a host of nutrients.”

While Wright doesn’t find the newly approved qualified health claim particularly useful, she says, “The whole grain health claim aims to address the quality of grains, in that whole grains contain more health-promoting nutrients than refined grains. But anyone, with or at risk of diabetes, needs to watch the quality of their carbohydrate intake, regardless of the source.” According to the 2010 Dietary Guidelines for Americans, the best way to do that is to replace some refined grains with whole grains.

Not even the FDA would disagree with that.

— Densie Webb, PhD, RD, is a freelance writer, editor, and industry consultant based in Austin, Texas.