FDA Definition of Whole Grains Limits Support for Heart Disease Claims

BETHESDA, MD (November, 2008) – Since 2005, FDA has allowed manufacturers to make health claims tying heart disease reduction to a diet rich in whole grains. Yet it was not until 2006 that FDA defined whole grains as the “the intact, ground, cracked or flaked fruit of the grains whose principal components-the starchy endosperm, germ and bran-…present in the same relative proportions as they exist in the intact grain.”

A new study by the Life Science Research Office announced on November 24, found that:

•“The FDA definition for whole grains as a selection criterion to evaluate the scientific literature is limiting because most of the studies use a broader concept of whole grains.

•The few studies that meet the FDA whole grains definition provide insufficient scientific evidence to support a CVD health claim.

•A whole grains and CVD health claim is supported when a larger number of studies that use a broader concept of whole grain that includes isolated bran, germ or fiber in their analysis of whole grains are also considered.

•The scientific evidence on risk reduction of diabetes and whole grain consumption is suggestive, but not conclusive, whether or not the study meets the FDA definition of whole grains.

•This type of analysis is complicated by the diversity in nutrients and bioactive components of different types of whole grains. “


The results of the study are part of an LSRO report titled, “Whole Grain Intake and Cardiovascular Disease and Whole Grain Intake and Diabetes: A Review.”