Folic Acid to Be Added to Grain Products

WASHINGTON —  The federal government will require food manufacturers to fortify most grain products such as bread, pasta, flour and rice with the nutrient folic acid, a B vitamin, to reduce the risk of birth defects of the nervous system, the Food and Drug Administration announced Thursday.

The action, taken after several years of study, represents a departure for the FDA, which traditionally has been reluctant to recommend the widespread use of vitamins except during pregnancy.

“It is a very big step when you fortify the food supply with any active substance,” FDA Commissioner David A. Kessler told reporters. “We’re confident that we’ll do good here. The scientific link between the intake of [folic acid] and the prevention of these birth defects is real.”

The rule, one of only a handful of government-mandated food fortifications in history, will become effective Jan. 1, 1998. It will apply to all grain products that bear the label “enriched.”

Federal health officials first recommended in 1992 that all women of childbearing age take folic acid to reduce the chances of having a baby with neural tube defects, particularly spina bifida and anencephaly.

Spina bifida, a leading cause of childhood paralysis, is a condition in which the spinal cord is exposed. In anencephaly, which is fatal, most or all of the brain is missing. Many experts believe that daily consumption of folic acid beginning before pregnancy and continuing into the first trimester can prevent up to 70% of these birth defects.

The March of Dimes Birth Defects Foundation, which has fought for the regulation for several years, called the action “a victory for mothers and babies” and predicted that it would result in fewer such defects.

“It’s so rare that we have the opportunity to prevent disabling or fatal birth defects by such a low-tech means,” said Dr. Jennifer L. Howse, president of the March of Dimes.

The federal Centers for Disease Control and Prevention has estimated that 4,000 pregnancies, including 2,500 live births, involve spina bifida or other neural tube defects.

Because more than half of all pregnancies are unplanned, and these birth defects occur in the developing fetus before most women know they are pregnant, “by fortifying grain products, we will increase the likelihood that all women of childbearing age get adequate folic acid levels in their diets,” Kessler said.

In 1992, the Public Health Service recommended that all women of reproductive age consume 0.4 milligrams of folic acid daily.

Folic acid naturally occurs in leafy, dark green vegetables, citrus fruits and juices, yeast and beans. Folic acid supplements and daily multivitamin preparations containing the nutrient also are widely available.

While many Americans already get folic acid in their diets, health officials have long been concerned about ensuring that pregnant women receive appropriate levels. Kessler said that the “average amount in a woman’s diet today probably gets you to half of that, so by enriching certain foods, we are making it easier.”

The products, once fortified under the new rule, should provide 10% of the daily recommended amount per serving, Kessler said. Specified grain products will be required to be fortified with folic acid at levels ranging from 0.43 milligrams to 1.4 milligrams per pound of product.

These amounts are designed to keep the daily intake below 1 milligram because amounts higher than that can mask the symptoms of pernicious anemia, a form of vitamin B-12 deficiency that primarily affects the elderly and, if untreated, can lead to severe permanent nerve damage, the agency said.

Fortification will be optional for breakfast cereals.

The addition of iodine to salt in 1924 to prevent goiter and other disorders was believed to be the first such food fortification requirement.