Vitamin E

Health claim proposed to FDA July 12 by Durk Pearson, Sandy Shaw, Julian Whitaker, MD, the American Preventive Medical Association and Pure Encapsulations. The claim states: "As part of a healthy diet low in saturated fat and cholesterol, 400 IU/day of vitamin E...may reduce the risk of heart disease. Individuals who take anticoagulant medicine(s) should consult their physician before taking supplemental vitamin E." The filing follows the submission of three other health claims by the group for psyllium, saw palmetto and folic acid (1"The Tan Sheet" May 24, p. 15). Filing of the vitamin E claim was delayed pending supportive data. Although FDA originally denied the claims, a federal appeals court ruled Jan. 15 the agency should consider allowing health claims with labeled disclaimers