FDA Completes Review of Qualified Health Claim Petition for Macadamia Nuts and the Risk of Coronary Heart Disease

Constituent Update

July 24, 2017

After conducting a systematic review of the available scientific data, the U.S. Food and Drug Administration now intends to exercise enforcement discretion over the use of a qualified health claim characterizing the relationship between consumption of macadamia nuts and reduced risk of coronary heart disease. The claim, which manufacturers can use immediately, reads:

“Supportive but not conclusive research shows that eating 1.5 ounces per day of macadamia nuts, as part of a diet low in saturated fat and cholesterol and not resulting in increased intake of saturated fat or calories may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content.”

The qualified health claim was in response to a petition filed by Royal Hawaiian Macadamia Nut, Inc. Qualified health claims are supported by scientific evidence, but do not meet the more rigorous “significant scientific agreement” standard required for an authorized FDA health claim. As such, they must be accompanied by a disclaimer or other qualifying language so that the level of scientific evidence supporting the claim is accurately communicated.

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