Qualified Health Claim


Companies using both EPA and DHA in their products have the advantage of being able to use a qualified health claim on their label. On September 8, 2004, the FDA announced the availability of a qualified health claim for reduced risk of Coronary Heart Disease (CHD) on conventional foods and dietary supplements that contain omega-3 fatty acids, EPA and DHA. The claim must read:

“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.]”

Other factors may apply. To view  additional requirements for health claims found in section 21 CFR 101.14, visit the FDA's website.  Click here to view.