FDA Proposes Folic Acid Fortification

By Williams, Rebecca D. | FDA Consumer, May 1994 | Go to article overview

FDA Proposes Folic Acid Fortification


Williams, Rebecca D., FDA Consumer


The message to pregnant women is clear. A little investment in nutrition now pays off richly in your baby's health later.

For that reason, the Food and Drug Administration proposed last October that all bread and grain products be fortified with folic acid, one of the B vitamins. Just 0.4 milligrams (mg) of the nutrient every day can greatly reduce the risk of neural tube defects, which affect the brain and spinal cord.

Folate is in many healthful foods. (Folate and folic acid are interchangeable terms. Folic acid is the synthetic form of folate, which is found naturally in some foods.) A bowl of lentil soup or fortified breakfast cereal, a large spinach salad, or a tall glass of orange juice will put a woman well on her way to 0.4 mg of folic acid.

The tricky part is that neural tube defects occur in an embryo before a woman may realize she's pregnant. Since more than half of pregnancies are unplanned, FDA has taken steps to fortify food so that all women of childbearing age get a daily dose of folic acid.

Without it, most women 19 to 50 get only 0.2 mg of folic acid each day, according to U.S. Department of Agriculture estimates. If the regulation is finalized within the next six months, FDA estimates that the fortified food will reach the plates of more than 90 percent of American women by 1995. If the move is successful in boosting women up to 0.4 mg of folic acid daily, it could cut the incidence of neural tube defects in this country by as much as half.

A Difficult Decision

Despite this benefit, the decision to add folic acid to food is difficult because it's so tricky to estimate what people eat. Most of the folic acid studies have been done with vitamin pills, not plates of food. It's hard for scientists to translate the results of those controlled studies into recommendations for the everchanging eating habits of Americans.

"As a scientific and policy matter, it is one of the more difficult [issues] I have confronted," said FDA Commissioner David A. Kessler, M.D., addressing a meeting of the March of Dimes last January. "Before we fortify the food supply for 250 million Americans, we have to make sure we get it right."

The amount of folic acid FDA has proposed adding is tiny-140 micrograms per 100 grams (3.5 ounces) of bread and other grain products like flour, rolls, buns, corn grits, cornmeal, farina, rice, and noodles. A microgram is one millionth of a gram. This alone will probably not meet a woman's need for 0.4 mg (400 micrograms) each day, depending on what she eats. She will have to get the rest of her folic acid either from a vitamin supplement or from other foods in her diet. FDA is considering whether to allow food manufacturers to make health claims about which foods and vitamin supplements are rich in folic acid.

This is no problem for those who eat foods rich in folate. Leafy green vegetables, citrus fruits, beans, and fortified breakfast cereals are great folate sources. In fact, anyone who follows the USDA Food Pyramid Guide, which suggests 3 to 5 servings of vegetables, 2 to 4 of fruits, and 6 to 11 servings of grains daily, can easily get 400 to 500 micrograms of folate each day.

The amount FDA is proposing be added to food is set below the level likely to cause harm from too much folate. A number of scientists believe that up to 1 mg (one-thousandth of a gram) of folic acid per day is safe. So even if someone followed USDA's guide, including eating fortified bread, and took a multivitamin with another 400 micrograms of folic acid, he or she would still be within safe limits.

The main problem is for older Americans. One in five people 65 to 95 lack sufficient vitamin [B.sub.12], a deficiency that can cause pernicious anemia. Extra folic acid can mask the symptoms of the condition, which may lead to permanent nerve damage if left untreated.

FDA's proposal has drawn both support and criticism from a wide range of health officials and scientists. …

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