FDA Moves Forward on Qualified Health Claims

The Food and Drug Administration today announced that a qualified health claim will soon appear on product labels for walnuts and the reduced risk of coronary heart disease. This qualified health claim is part of the FDA’s initiative to provide Americans with better information to help them make healthier dietary choices.

“By using science based information to evaluate qualified health claims, the FDA is making sure that consumers get information about the nutritional value of foods,” said FDA Acting Commissioner, Lester M. Crawford, D.V.M., Ph.D.

Part of the criteria for making a qualified claim on a conventional food is to provide credible scientific evidence supporting the claim. Based on a systematic evaluation of the available scientific data, as outlined in FDA’s “Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements”, FDA moved forward to allow a qualified health claim for whole and chopped walnuts. FDA’s review concluded that supportive research shows that walnuts may reduce the risk of coronary heart disease when consumed as part of a low saturated fat and low cholesterol diet and not resulting in increased caloric intake. While this research is not conclusive, FDA believes that consumers will benefit from having information that may help them improve their dietary health.

As a result, consumers will soon see claims on walnuts stating: "Supportive but not conclusive research shows that eating 1.5 oz of walnuts per day, as part of a low saturated fat and low cholesterol diet, and not resulting in increased caloric intake may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content."

The use of the bracketed phrase “and calorie” is optional because FDA believes that this additional information would benefit consumers by heightening their awareness of the caloric contribution from walnuts. The presence or absence of the bracketed phrase will not be a factor in FDA’s enforcement of this qualified health claim.

The guidance on health claims, issued July 2003, sets forth the conditions under which the agency intends to exercise enforcement discretion for qualified health claims about conventional foods and dietary supplements. The qualified health claim may be viewed on line at http://www.cfsan.fda.gov/~dms/qhcnuts3.html.

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