Regulatory Issues: FDA Denies Petition on Whole Grain Descriptors
Currently, hundreds of products are marketed with “whole grain” statements, despite ambiguity concerning the regulatory status of descriptors such as “good” and “excellent” source.
By Leslie T. Krasny, Contributing Editor | 02/23/2006
There is no Daily Value established by the FDA for whole grains. However, the 2005 Dietary Guidelines recommend consuming 48g per day (three servings of 16g each), and the Dietary Guidelines must “be promoted by each Federal agency in carrying out any Federal food, nutrition, or health program.”
In May 2004, General Mills submitted a citizen petition to the FDA requesting definitions be developed for "excellent source", "good source" and "made with" as descriptors for the whole grain content of foods. General Mills recommended that a “good” source and “made with” should contain at least 8g of whole grains, and that an “excellent” source should contain at least 16g. General Mills stated that the descriptors are not nutrient content or health claims, and that “whole grain” is a substance, rather than a broad category of food. The Whole Grains Council licenses a symbol, the Whole Grain Stamp (see below), for use on the packaging of products meeting “8g/good source, 16g/excellent source” criteria.
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.