FDA Needs to Further Define Whole Grain Labeling

March 1, 2006
Editor in Chief Dave Fusaro urges food processors to tell the FDA to finish the job and define what are 'good' and 'excellent' sources of whole grains.

The FDA took a big step forward last month for healthier eating and better nutrition communication by food processors when it published a draft guidance on whole grain content. Unfortunately, the agency stopped short of the ultimate and really useful goal of explaining to consumers - actually, letting processors explain to consumers - how much whole grain they should eat.

One important thing to remember is this, like most FDA draft documents, starts a clock ticking that allows for 60 days of public comment on the proposal. So the agency has nearly two months to get it right. And you have probably about a month from the time you read this to tell them how to get it right.

The Feb. 15 guidance document (which may be accessed by clicking on the "Download Now" button below) defines whole grains as "cereal grains that 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." Nothing revelatory there; the agency merely is following what all responsible parties, including the American Assn. of Cereal Chemists, have said about whole grains.

Defining what is a grain was slightly more contentious. For the most part, the agency's definition is synonymous with "cereal grains," meaning "amaranth, barley, buckwheat, bulgur, corn (including popcorn), millet, quinoa, rice, rye, oats, sorghum, teff, triticale, wheat and wild rice." But the agency concedes that almost all barley used for food production in the U.S. has such an inedible hull that, once it's pearled, it can no longer be considered a whole grain. FDA does not consider products derived from legumes (such as soybeans and chickpeas), oilseeds (sunflower seeds) and roots (arrowroot) to be whole grains.

The agency left it up to food marketers to decide if quantifying the whole grain was appropriate. So "100% whole grain," "10 grams of whole grains" or "1/2 ounce of whole grains" are permitted statements "if truthful and not misleading and stated on a per serving basis. And labels may bear a health claim based on an authoritative statement of a scientific body relating whole grains with a reduced risk of heart disease and certain cancers if the product meets the criteria of [prior] notifications."

All well and good. But the thing most consumers will want to know is "How much should I eat? Am I getting enough whole grains?" With such a strong pitch for whole grains in the 2005 Dietary Guidelines for Healthy Americans, this kind of practical consumer guidance cannot be overlooked. Yet, the agency wrote:

"At this point, FDA takes the position that claims should not imply a particular level of whole grains, such as ‘good' or ‘excellent' source, because the terms are not defined by regulation and consumers may have no way to determine the quantity of whole grains in the products. Regarding the regulatory status of current label claims that imply a particular level of whole grains (often based on consumption recommendations in the 2005 Dietary Guidelines for Americans), FDA will review the labeling in its entirety and make a determination on a case-by-case basis as to whether the claims are truthful and non-misleading."

There is no original work that needs to be done to quantify what makes a "good" or "excellent" source of whole grains. The food industry has taken care of that. And it's simple math. A "good source of whole grains" is 8g, or half a serving as recommended by the Dietary Guidelines (the guidelines recommend three servings, or about 3 oz. total of whole grain products, per day). An "excellent source" is 16g, or a full Dietary Guidelines serving. Oldways Preservation Trust and its Whole Grains Council are among the groups that advocate this simple approach.

Maybe "the terms are not defined by regulation," as FDA says. So define them. What's the big deal?

As I said, the agency is accepting comments through about April 17. Tell the FDA to fill this obvious void by submitting comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Md., 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

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