The Food and Drug Administration (FDA) has announced the availability of a qualified health claim for reduced risk of coronary heart disease (CHD) on conventional foods that contain eiscosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids.

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.

"Coronary heart disease is a significant health problem that causes 500,000 deaths annually in the United States," said Dr. Lester M. Crawford, Acting FDA Commissioner. "This new qualified health claim for omega-3 fatty acids should help consumers as they work to improve their health by identifying foods that contain these important compounds."

A qualified health claim on a conventional food must be supported by credible scientific evidence. 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 is announcing a qualified health claim for EPA and DHA omega-3 fatty acids. While this research is not conclusive, the FDA intends to exercise its enforcement discretion with respect to the following qualified health claim:

"Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat and cholesterol content.]

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: http://www.cfsan.fda.gov/~dms/lab-qhc.html.

FDA Letter to Emord & Associates Responding to Omega-3 Health Claim Petition
FDA Letter to Hogan & Hartson Responding to Omega-3 Health Claim Petition
Petitions - Docket No. 2003Q-0401