Advisory Committee for Reproductive Health Drugs


December 15, 2003 Meeting on Addition of Folic Acid to Oral Contraceptive Pills




Physiology of folic acid and etiology of NTDs


Scott JM, Weir DG, Molloy A, McPartin J, Daly L and Kirke P. Folic acid metabolism and mechanisms of neural tube defects. Ciba Found Symp 1994; 181: 180-91


Minimum dose for prevention of NTDs


**Daly S, Mills JL, Molloy AM, Conley M, Lee YJ, Kirke PN Weir DG and Scott JM. Minimum effective dose of folic acid for food fortification to prevent neural-tube defects. Lancet 1997; 350: 1666-9


Mills JL. Fortification of foods with folic acid how much is enough? N Engl J Med 2000; 342: 1442-5


Various. CORRESPONDENCE Fortification of Foods with Folic Acid. N Engl J Med 2000; 343:970-72


**Wald NJ, Law MR, Morris JK and Wald DS. Quantifying the effect of folic acid. Lancet 2001; 358: 2069-73


History of food fortification


Feinleib M, Beresford SA, Bowman BA, Mills JL, Rader JI, Selhub J, Yetley EA. Folate fortification for the prevention of birth defects: case study. Am J Epidemiol 2001;154 (Suppl): S60-9


Impact of fortification on epidemiology of NTDs


**Honein MA, Paulozzi LJ, Mathews TJ, Erickson JD and Wong LY. Impact of folic acid fortification of the US food supply on the occurrence of neural tube defects. JAMA 2001; 285: 2981-6

**Persad VL, Van den Hof MC, Dube JM and Zimmer P. Incidence of open neural tube defects in Nova Scotia after folic acid fortification. CMAJ 2002; 167: 241-5


Ray JG, Meier C, Vermeulen MJ, Boss S, Wyatt PR, Cole DE. Association of neural tube defects and folic acid food fortification in Canada. Lancet 2002; 360: 2047-8


Safety issues in folic acid supplementation


Butterworth CE Jr and Tamura T. Folic acid safety and toxicity: a brief review. Am J Clin Nutr 1989; 50: 353-8.


** These articles are not included in this packet; they are among the references provided by Johnson & Johnson in their briefing book.