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FDA Postpones Making Health Claim Decisions

WASHINGTON--On Oct. 24, the Food and Drug Administration (FDA) postponed making a decision on the two remaining Pearson v. Shalala health claims concerning omega-3 fatty acids and antioxidants.

In a letter to the law firm Emord & Associates, Christine Lewis (FDA's director for the Office of Nutritional Products, Labeling and Dietary Supplements at the Center for Food Safety and Applied Nutrition) announced that, "due to the complexity of the issues raised by the reviews" of both claims, as well as staffing constraints, the agency needed to extend its review period for both health claims.

FDA stated that, in regards to omega-3 fatty acids affecting coronary heart disease, "new and complex issues" prevented the agency from releasing its claim evaluation until Oct. 31.

As for the potential benefits of antioxidants on cancer, the agency stated that it needed to research the large amount of human studies that had been conducted since its initial review (from 1991 to 1993). Also, because this proposed claim covers many types of antioxidants and cancers, additional time is needed to "consider fully the complexity of the claims and the relevant information available in the record;" FDA expects to issue this decision by Nov. 30.

For a copy of this letter, www.cfsan.fda.gov/~dms/ds-ltr10.html.

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