Department of Health and Human Services Food and Drug Administration 21 Cfr Part 101 Food Labeling: Health Claims and Label Statements; Folic Acid and Neural Tube Defects

Agency: Food and Drug Administration, HHS. Action: Final Rule. __________________________ SUMMARY: The Food and Drug Administration (FDA) is announcing its decision not to authorize a health claim for folic acid and neural tube defects at this time. However, consistent with the recently announced recommendations of the U.S. Public Health Service (PHS) that all women of childbearing age in the United States consume 0.4 milligram (mg) (400 micrograms (pg)) of folic acid daily to reduce their risk of having a pregnancy affected with spina bifida or other neural tube defects. FDA plans to work expeditiously to authorize a claim, if appropriate. At that time the PHS identified several issues that remain outstanding, including the appropriate level of folic acid in food and safety concerns regarding increased intakes of folic acid. Given the significance of neural tube defects and the PHS recommendation, the agency is continuing to address the issues about folic acid. FDA recently convened an advisory committee to consider the outstanding concerns (57 FR 52781, November 5,1992). The advisory committee provided recommendations to the agency on the following issues: (1) What is the target population for a folic acid neural tube defect health claim? (2) How does the information available on the effective level of intake affect options for implementation? (3) What safety concerns for the target population and for persons in the general population must be addressed? and (4) If a claim is authorized, what is the most appropriate method for presenting it to the target population? The advisory committee’s recommendations are currently under FDA review.