FDA Releases Draft Guidance on the Term "Whole Grain"

The Food and Drug Administration (FDA) recently released draft guidance for label statements on the whole grain content of foods. Dairy processors that are using, or considering using, whole grains in their products — such as in yogurts — may wish to review this draft guidance and consider submitting comments. FDA is accepting comments through April 17.

FDA's guidance is not expected to become regulation, but labels that do not follow the guidance could be considered false or misleading. This issue has gotten more attention from FDA due to last year's release of the 2005 Dietary Guidelines for Americans, which encourage the consumption of whole grains. This dietary advice has spurred more manufacturers to add whole grain ingredients and to make label statements about the whole grain content of their products.

FDA's draft guidance defines whole grains as the "intact, ground, cracked or flaked" grain with the principal parts of the grain (endosperm, germ and bran) in the same proportions as would be found in the intact grain. Currently, there are no defined levels for "good source" or "excellent source" claims for whole grains. The draft guidance reinforces that since these claims are not defined, they cannot be made on food labels. The guidance recommends that statements that are truthful and not misleading, such as "100% whole grain" or "10 grams of whole grains," would be allowed as long as they don't imply "good source" or "excellent source" claims. In addition, products may make health claims linking whole grain content to a reduced risk of heart disease or cancer if they meet the regulatory requirements of those claims.

To read FDA's press release on the draft guidance, and to review the draft itself, click here.

If you have any questions or concerns about the guidance or whole grain labeling, please contact Michelle Matto at mmatto@idfa.org, or 202-220-3523 or Cary Frye at cfrye@idfa.org or 202-220-3543.

Posted March 6, 2006