Whole Grains&Health Speech: May 20, 2005

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Speech before

Whole Grains & Health
A Global Summit
Minneapolis, MN

Remarks by

Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner of Food and Drugs

May 20, 2005

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Good Morning. Thank you, Allen (Dr. Allen Levine, Dept. Head, Food Science and Nutrition, University of Minnesota and Director, Minnesota Obesity Center) for your kind introduction. I’m honored to be with you this morning here in the Twin Cities.

Its very fitting that a global summit on the role of whole grains in health should be held here in the twin cities, this area has a rich history as the epicenter of grain production in this country. The Minneapolis Grain Exchange is still central to the trading of grain futures and home to some of our oldest grain-based food companies like General Mills.

I know you have had two days of fruitful discussion on scientific issues surrounding the role of whole grains in reducing the risks of certain chronic diseases, as well is the technology of developing useful and consumer-accepted whole grain food products.

I also know for those of you in the business of manufacturing whole-grain food products that being able to identify these health benefits on the food label is very important. So this morning I’m going share with you a bit of the history of FDA’s role in food labeling relative to the benefits of whole grains, and where we are headed.

As most of you probably know, the Department of Health and Human Services, in conjunction with the Department of Agriculture released the 2005 Dietary Guidelines in January of this year. Now I know that earlier in this conference you heard from Dr. Barbara Schneeman, of FDA’s Center for Food Safety and Applied Nutrition, some of the details of the new guidelines but let me just emphasize a couple of points.

For the first time since their inception, these Dietary Guidelines include recommendations on weight management and physical activity. The Guidelines also contain a chapter on food groups that should be encouraged in a healthy diet, and certainly, whole grain foods is one of those groups.

Many of you may know that when the National Academy of Sciences/Institute of Medicine published their report on the Dietary Reference Intakes for Macronutrients, the dietary requirement for fiber was increased significantly based on scientific evidence of its health benefits. The requirement was set at 14 grams of fiber per 1000 calories. So the average person with a 2000-calorie intake needs 28 grams of fiber per day.

It’s extremely difficult to get that much fiber in your diet without the consumption of whole grains, and the Dietary Guidelines recognize and promote the intake of whole grains as an important source of dietary fiber.

In fact, the recommendation is that at least half of all grain products consumed should be whole grain products.

Since consumers generally can’t identify whole grain foods simply by looking at them, this information needs to be on the food label. The first way that consumers can identify a whole grain product is by looking at the ingredient list. In order for a food product to be considered a whole grain product, and to use a health claim on its label it must contain 51 percent or more whole grain ingredients by weight. This means, of course, that whole grain should be the first ingredient in the ingredient list.

In order for a manufacturer to make a nutrient content claim on a food product of a “good” source of dietary fiber, it must contain 10 to 19 percent of the recommended daily intake or Daily Reference Value (DRV) of fiber per serving. If you want to label your product as an “excellent” source of dietary fiber it must contain 20 percent or more of the recommended daily intake per serving.

During the development and implementation of the NLEA back in 1993, Congress and FDA considered the available science at that time and recognized the benefits of fiber, and whole grains as a source of fiber. FDA authorized two health claims, which, as you know, must be based on significant scientific agreement.

The first claim that was permitted stated that low-fat diets rich in fiber-containing grain products, fruits and vegetables may reduce the risk of some cancers. This claim can be applied only to foods that contain grain, fruit, or vegetable products and meet the nutrient content claim of a “good” source of dietary fiber (without fortification or supplementation). These products must also meet the nutrient content claim for being a “low” fat product.

The second health claim that was authorized with the implementation of the NLEA has to do with the soluble fiber content. In this case, the claim may state that soluble fiber (primarily beta-glucans) from food such as whole oat products, as part of a diet low in saturated fat and cholesterol may reduce the risk of coronary heart disease. The eligible sources of soluble fiber allowed include oat bran, rolled oats, whole oat flour, oatrim and psyllium husk.

In 1997, when Congress passed the FDA Modernization Act (FDAMA) they specifically provided for the use of health claims based on authoritative statements from a scientific body of the U.S. Government or the National Academy of Sciences.

We issued Guidance to Industry in 1998 that outlined submission procedures for health claims based on authoritative statements, and defined what would be considered an authoritative statement.

Any company wishing to make such a health claim on a traditional food item must submit a notification to FDA that contains the exact wording of the claim. Notification of the claim must be submitted 120 days prior to marketing the product.

I should emphasize that FDAMA does not include dietary supplements in its provision for health claims based on authoritative statements, so this method of oversight can’t be used for dietary supplements at this time.

In 1999, we approved the first health claim for whole grain foods under FDAMA. The approved labeling statement can indicate, “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”.

In 2003 we approved a second health claim for whole grain foods. This labeling statement can indicate, “diets rich in whole grain foods and other plant foods, and low in saturated fats and cholesterol, may reduce the risk of heart disease and certain cancers.

The difference between the two statements is that because fat, per se, is not associated with increased risk of heart disease, it’s the saturated fat and cholesterol that are the problem; foods bearing the second health claim do not need to meet the nutrient content claim of a “low fat” food, but can contain moderate levels of fat.

So, where are we today with respect to label claims for whole grain foods?

Currently FDA allows truthful and non-misleading statements about the presence or use of whole grain ingredients. Such as: “whole grain”, “multi-grain”, or similar statements, if all of the grain ingredients are whole grain. We do not object to the use of the term “whole grain” to refer to ingredients or foods that meet the Cereal Chemists’ Definition of whole grain. That is the intact, ground, or flaked grain, where the principal anatomical components of the grain (starchy endosperm, germ, bran) are present in the same relative proportion, as they exist in the intact grain.

However, we will consider a “100 % Whole Grain” statement false and misleading if the product contains any ingredient other than whole grains. From an enforcement standpoint we must consider the appropriateness of the statement in the entire context of the label and its ingredients.

Where do we go from here? CFSAN has, as one of its priorities for the coming year, the development of a strategy to initiate rulemaking on label claims for whole grains. As a part of this priority we expect to define the term “whole grain” and establish the framework for appropriately using claims about whole grains considering the recommendations of the Dietary Guidelines.

CFSAN is currently reviewing the petition from General Mills requesting us to also develop definitions of “good source” and “excellent source” of whole grains. We believe this is an important component of our strategy to provide consumers with the tools they need to lead healthier lives through better nutrition.

In conclusion, I believe that FDA has made significant progress to date in implementing the recommendations of the report from our Obesity Working Group that focused on ways to change the food label, including the use of Nutrient Content Claims, Health Claims, Qualified Health Claims and comparative statements to provide consumers better information to make informed and healthy choices about their diet.

I commend all of you attending this conference for your interest and efforts in promoting the use of whole grains to improve the health of U.S. consumers and look forward to a continued close working relationship with the food industry in this regard.

Thank you.

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