FDA Allows "Qualified" Health Claim on Omega-3-fortified Foods

12/02/2004

The Food and Drug Administration (FDA) recently announced it will allow a qualified health claim for reduced risk of coronary heart disease (CHD) on conventional foods that contain eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids. The claim may read: “Supportive but not conclusive research show that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”

Typically, EPA and DHA omega-3 fatty acids are contained in oily fish, such as salmon, lake trout, tuna and herring. These fatty acids are not essential to the diet; however, scientific evidence indicates that these fatty acids may be beneficial in reducing CHD.

A qualified health claim on a conventional food must be supported by credible scientific evidence. In 2000, FDA announced a similar qualified health claim for dietary supplements containing EPA and DHA omega-3 fatty acids and the reduced risk of CHD. FDA recommends that consumers not exceed more than a total of 3 grams per day of EPA and DHA omega-3 fatty acids, with no more than 2 grams per day from a dietary supplement.

The EPA and DHA omega-3 fatty acid qualified health claim is the second qualified health claim that FDA has announced for conventional food. For additional information about QHC visit: www.cfsan.fda.gov/~dms/lab-qhc.html.