Regulatory Issues: Serving up whole grains
With consumers increasingly aware of the benefits of whole grains, a simple, factual statement about their presence is enough.
By David Joy, Contributing Editor | 04/04/2005
As the public becomes increasingly aware of the benefits associated with whole grains, many food manufacturers are looking to add whole grains to their products and to make label claims about them. This raises the question: What exactly can be said about whole grains on a food label?
Claims regarding whole grain content should not be classified as “nutrient content claims.” Food labeling law requires that nutrient content claims be authorized by the Food and Drug Administration. Claims in this category are claims that characterize the level at which certain nutrients are present in food (claims such as “rich in calcium”).
Whole grains arguably do not qualify as “nutrients.” What characterizes whole grains is that they consist of the entire grain seed, usually called the kernel. The kernel is made up of three components: bran, germ and endosperm. All types of grain are included in the “whole grain” category, including brown rice, oatmeal, whole wheat and even popcorn, each with a different nutrient profile. Thus, while “complex carbohydrates” might be regarded as nutrients, “whole grains” should be regarded as a category of food ingredient, not a nutrient.
If whole grain claims are not nutrient content claims what are they? At a minimum, these claims are governed by the prohibition against false or misleading statements on food labels. A factual statement that a food contains X grams of whole grains per serving should be fairly safe, provided the claimed quantity is not so small as to be nutritionally insignificant. On the other hand, claims such as “rich in whole grains” that characterize the level as high, are a bit more uncertain. FDA has not yet issued guidance regarding these types of claims. A petition currently pending with FDA asks the agency to define the claims “excellent source,” “good source” and “made with” for whole grains.
While this petition is pending, food manufacturers are proceeding to make label claims regarding whole grain content.
Some benefits linked to whole grains include weight loss, reduced risk of heart disease and better maintenance of diabetes. Whole grains receive favorable attention in the 2005 Dietary Guidelines for Americans and are included in the South Beach Diet. These things can be freely said in a magazine column, but can they be stated on a food label?
Any message about whole grains that would qualify as a health claim requires either an authorization from FDA or a notification to FDA. Health claims are statements that characterize the relationship of any specific food or food component to a disease or health-related condition. Health claims are often phrased in the form: “Substance X may reduce the risk of disease Y.”
There are three paths available to obtain clearance for a new health claim:
- A manufacturer can petition FDA for authorization of a traditional health claim.
- A manufacturer can notify FDA that it intends to make a health claim based on an authoritative statement from a federal scientific agency, as provided for under the Food and Drug Administration Modernization Act (FDAMA).
- A manufacturer can petition FDA for a “qualified health claim” if the “significant scientific agreement” standard for a traditional health claim is not met.
Two health claims for whole grains have been successfully notified to FDA under the procedure established by FDAMA. In 1999, the following health claim was notified, intended for foods that contain at least 51% whole grain ingredients:
Diets high in plant foods – i.e., fruits, vegetables, legumes and whole-grain cereals – are associated with a lower occurrence of coronary heart disease and cancers of the lung, colon, esophagus and stomach.
In 2003, the following health claim was notified to FDA, applicable to foods that contain at least 51 percent whole grain ingredients and have a moderate fat content:
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.”
No doubt, manufacturers would like to say even more about whole grains on food labels. Given that consumers are increasingly aware of the benefits associated with whole grains, manufacturers may find that a simple, factual statement about their presence is enough.