Global review of heart health claims for oat beta-glucan products.

Coronary heart disease (CHD) is the leading cause of death globally. Consumption of whole grains and cereal fiber, as part of a healthy diet, can lower the risk of CHD. Health claims on food products are effective in helping consumers select healthful diets. The US Food and Drug Administration was the first to approve a health claim, in 1997, between beta-glucan soluble fiber from whole oats, oat bran, and whole oat flour and reduced risk of CHD. Only a few countries have approved similar claims. Since 1997, a significant amount of additional evidence has been published on the relationship between oat beta-glucan and CHD. To assist other jurisdictions in potentially utilizing this claim, the full extent of data that supports this claim (ie, the evidence utilized by the US Food and Drug Administration to substantiate the claim, as well as the results of 49 clinical trials published since 1997) are reviewed here. The complexities involved in authoring evidence-based health claims, including the impact of processing on beta-glucan cholesterol-lowering efficacy in approving eligible beta-glucan products, are also discussed.