Food Labeling: Health Claims and Label Statements; Folate and Neural Tube Defects

The Food and Drug Administration (FDA) is authorizing the use on the labels and in the labeling of food, including dietary supplements, of health claims on the association between adequate intake of folate and the risk of neural tube birth defects. This rule is issued in response to provisions of the Nutrition Labeling and Education Act of 1990 (the 1990 amendments) that bear on health claims. The agency has concluded that, based on the totality of the publicly available scientific evidence, there is significant scientific agreement among qualified experts that, among women of childbearing age in the general U.S. population, maintaining adequate folate intakes, particularly during the periconceptional interval, may reduce the risk of a neural tube birth defect-affected pregnancy.