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June 28th, 2008 at 7:32am
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FDA/CFSAN: Letter Regarding Dietary Supplement Health Claims for Omega-3 Fatty Acids and Coronary Heart Disease
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U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Nutritional Products, Labeling, and Dietary Supplements October 31, 2000 Letter Regarding Dietary Supplement Health Claim for Omega-3 Fatty Acids and Coronary Heart Disease (Docket No. 91N-0103) Letter References Tables 1, 2 and 3 Jonathan W. Emord, Esq. Emord & Associates, P.C. 1050 17th Street, N.W. Suite 600 Washington, D.C. 20036 Dear Mr. Emord: 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. Shalala , 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. Procedure and Standard for Evaluating the Claim In reconsidering this claim and the three other health claims that were the subject of Pearson , FDA has proceeded as described in the October 6, 2000, Federal Register notice entitled "Food Labeling; Health Claims and Label Statements for Dietary Supplements; Update to Strategy for Implementation of Pearson Court Decision" (hereinafter "the Pearson implementation notice")(65 Fed. Reg. 59,855 (2000)). As noted below in section IV, FDA first gathered new scientific evidence on the claims by contracting for a literature search and publishing two notices in the Federal Register soliciting comments and data. After reviewing the updated body of evidence on the claims, FDA applied the "significant scientific agreement" standard by which the health claim regulations require the agency to evaluate the scientific validity of claims. Under this standard, FDA may issue a regulation auth"
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