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

The Food and Drug Administration (FDA) is announcing that, in accordance with the Nutrition Labeling and Education Act of 1990 (the 1990 amendments), as amended by the Dietary Supplement Act of 1992 (the DS act), the regulation proposed on October 14, 1993 (58 FR 53254), to authorize the use of a health claim about the relationship between folate and the risk of neural tube defects (NTD's) is now considered a final regulation for dietary supplements of vitamins, minerals, herbs, and other similar nutritional substances (dietary supplements). The proposed regulation set out the information that must be included in such a health claim to ensure that it is an accurate representation of the effect of intake of folic acid on the risk of NTD's, and that any claims that are made are understandable, informative, and not misleading.