Food Fortification with Folic Acid Prevents Spina Bifida and Anencephaly: A Need for Paradigm Shift in Evidence Evaluation for Policy-Making.

Modern epidemiology advocates context-specific evidence evaluation to support public health policy decisions, avoiding excessive reliance on experimental designs. We present the rationale for a paradigm shift in evaluation of the evidence derived from independent studies as well as systematic reviews and meta-analyses of observational studies, applying Hill's criteria (including coherence, plausibility, temporality, consistency, magnitude of effect, and dose-response) to evaluate food fortification as an effective public health intervention. A critical appraisal of published evidence between 1983 - 2020 supports the conclusion that food fortification with folic acid prevents folic-acid preventable spina bifida and anencephaly (FAP SBA). Policymakers should be confident that, with mandatory legislation, effective implementation, and periodic evaluation, food fortification assures women of reproductive age will safely receive daily folic acid to significantly reduce the risk of FAP SBA. Current evidence should suffice to motivate political will to implement programs that will save thousands of lives each year in over 100 countries.