JAMA: Folic-Acid-Fortified Foods and Healthier Babies

ATLANTA--Government-mandated folic acid fortification in cereals may have led to fewer health defects. In the June 20 Journal of the American Medical Association (JAMA) (285, 23:2981-6, 2001) (http://jama.ama-assn.org), researchers extracted data from 100,000 birth certificates for live births by women in 45 states between January 1990 and December 1999. They then compared women before and after the Food and Drug Administration (FDA) required enriched cereal manufacturers to fortify every 100 g of grain with 140 mcg of folic acid. It was found that the occurrence of neural tube defects dropped 19 percent, from 37.8 per 100,000 live births to 30.5 per 100,000. Despite this good news, the authors--led by Margaret Honein from the National Center of Birth Defects and Developmental Disabilities based here--cautioned that this decline in defects may have been due to other contributing factors, and not the increased intake of folic acid.

In an accompanying letter, James Mills, M.D., and Lucinda England, M.D., both from the National Institutes of Health (www.nih.gov) in Bethesda, Md., acknowledged that the study leaves some important questions unanswered (such as how were all neural tube defects noted if miscarriages or stillborns--both of which do not receive birth certificates--are not taken into account). Nonetheless, "[t]his exciting news clearly validates the U.S. government's decision to intervene on a massive scale to prevent these devastating birth defects," wrote Mills and England.

They also bring up the question of raising folic acid fortification levels. More data is needed to assess the overall risk-benefit ratio of this potential action, but the scales are tipped in favor of raising these levels due to the additional benefit folic acid intake has on lowering the risk for heart disease, according to Mills and England.

Even though this study confirms what the industry has been saying for years, it was only in the last few months that the Food and Drug Administration (FDA) (www.fda.gov) unwillingly allowed dietary supplement manufacturers to utilize a health claim for 800 mcg of folic acid. However, the agency all but contradicted this claim through the wording of its disclaimer: "FDA does not endorse this claim. Public health authorities recommend that women consume 0.4 mg folic acid daily from fortified foods or dietary supplements or both to reduce the risk of neural tube defects."

The Secretary of Health and Human Services, Tommy Thompson, released a statement in regard to the study's findings: "The Centers for Disease Control and Prevention's (CDC) finding that certain debilitating birth defects, such as spina bifida, have decreased by 19 percent following folic acid fortification of the U.S. food supply and related educational efforts is wonderful news. This finding highlights how extremely important prenatal care is to ensuring the health and well-being of our nation s children."

Meanwhile, as more scientific evidence shows the benefits of folic acid, Mills and England suggest that "women of childbearing age should be advised to take a vitamin supplement containing 400 (micrograms per day) of folic acid to obtain the maximum protection against the development" of neural tube defects.

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