Whole-Grain Guidance

In mid-February, FDA released “Guidance for Industry and FDA Staff: Whole Grain Label Statements.” When finalized, the document will represent the agency’s current view of what constitutes a whole grain. The intent is to help manufacturers develop appropriate food labels and, in turn, help consumers make informed dietary decisions.

Presented in a Q&A format, the draft guidance considers cereal grains, for example, whole-grain foods if they consist of the “intact, ground, cracked or flaked caryopsis, whose principal anatomical components—the starchy endosperm, germ and bran—are present in the same relative proportions as they exist in the intact caryopsis.” On the other hand, products derived from legumes (soybeans, chickpeas), oilseeds (sunflower seeds) and roots (arrowroot) are not considered whole grains.

Currently, manufacturers can include health claims on food labels relating consumption of whole grains to a reduced risk of coronary heart disease and certain cancers, and can make factual statements indicating the amount of whole grains in a product. However, labels may not make false or misleading statements, or imply a level of the ingredient, such as “high” or “excellent” source.

This last directive is at odds with the whole grain stamp program implemented by the Whole Grains Council (WGC), Boston, in Jan. 2005. The stamps identify products as providing one of three levels of whole grains: “Good Source,” “Excellent Source,” and “100% Excellent Source.” Based on recommendations from the 2005 Dietary Guidelines for Americans to consume at least 3 oz. of whole-grain bread, cereal, crackers, rice or pasta every day, the stamps provide a quick, easy way for consumers to identify products containing whole grains, according to WGC. “Good Source” products provide 17% of the recommended daily consumption, while “Excellent Source” items offer 33%. According to WGC, some 600 products bear the whole grain stamp. WGC stands by the whole grain stamp program, maintaining that “although this draft guidance reflects the ‘current thinking of the FDA,’ it does not have any regulatory force, as long as packaging on a product is truthful and not misleading.”

At a Feb. 15, 2006, media teleconference announcing the release of the draft guidance, Barbara Schneeman, Ph.D., director of FDA’s Office of Nutritional Products, Labeling and Dietary Supplements at the Center for Food Safety and Applied Nutrition (CFSAN), was questioned about how the guidance impacts the WGC stamp program. “We would look at a product to make sure that the information on that product is truthful and not misleading,” she says. “So, with this guidance, the industry has a very good indication of FDA’s thinking, and they know the kinds of things we’re likely to look for in that product labeling information.” According to verbiage on the guidance itself, the document does “not establish legally enforceable responsibilities.” Instead, it “should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.”

Written or electronic comments concerning the draft guidance will be accepted until April 18, 2006. See www.cfsan.fda.gov/~dms/flgragui.htmlor call 301/436-2371 for complete details.