Letter Regarding Dietary Supplement Health Claim for Omega-3 Fatty Acids and Coronary Heart Disease

This letter is in reference to the court decision directing the Food and Drug Administration (FDA) to reconsider the health claim “Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease” in dietary supplement labeling (Pearson v. Shalufu, 164 F.3d 650 (D.C. Cir. 1999)). FDA has sent you replies on two of the other health claims that the court directed FDA to reconsider, namely, folic acid and neural tube defects and fiber and colorectal cancer. FDA will address, in a separate letter, the remaining health claim on antioxidants and cancer. We regret the delay in responding.