There has been opposition to the petition, particularly from bread and pasta manufacturers, because the higher water content of their products may make it difficult to meet those criteria. ConAgra Foods, in June 2005, filed comments suggesting different definitions: at least 5g for a "good" source, and at least 10g for an "excellent" source.
The FDA denied the General Mills petition in November, although acknowledged "the need for action on this topic." One reason for the denial was that the whole grain descriptors would be considered implied nutrient content claims about fiber (the position taken in the final rule on nutrient content claims in 1993). The FDA emphasized that factual statements, such as "10g of whole grains" and "100 percent whole grain oatmeal," are permitted if truthful and not misleading.
Another concern was "whether ‘whole grains' should be considered a food category, food ingredient, nutrient or something else." The FDA stated: "We are reviewing options for public input on how to classify certain statements about food, including dietary guidance statements. Our review includes possible approaches on how to provide useful information to the public on whole grains. In addition, we are considering the development of guidance on what we consider the term ‘whole grains' to include."
The Whole Grains Council, noting that a typical portion of whole grain food is unlikely to be a "good" or "excellent" source of fiber per serving, believes the petition denial may indicate the FDA is reexamining its view that certain whole grain statements are implied nutrient content claims about fiber. Accordingly, the council is urging industry to continue using "good" and "excellent" source of whole grains statements in order to educate the public about beneficial levels of whole grains, while awaiting an FDA standard.
The FDA cautioned that companies may be subject to regulatory action unless their whole grain statements are in compliance with the regulations. However, it is unclear whether the FDA will exercise enforcement discretion with respect to products making "good" and "excellent" source descriptors if the statements are based on at least 10 percent or 20 percent respectively of the Dietary Guidelines whole grain recommendation.
Moreover, the FTC will not necessarily consider "good" and "excellent" source whole grain descriptors to be implied nutrient content claims about fiber, and thus companies may be able to rely on substantiation for "good" or "excellent" source whole grain descriptors, in advertising, based on the Dietary Guidelines recommendation. For now, the safe approach is to use factual statements.
About the Author
Leslie T. Krasny is a partner at the law firm of Keller and Heckman LLP, San Francisco office. She specializes in food and drug law, with emphasis on food safety, food labeling, ingredient evaluation, organics, biotechnology and advertising. She is a member of the California Bar and holds a master's degree in cell and molecular biology. For more information about Keller and Heckman, visit the firm's web site at www.khlaw.com.
