FDA Folic Acid Report

FOLIC ACID FORTIFICATION

Background:

The U.S. Public Health Service recommended in September 1992 that all women of childbearing age consume 400 micrograms (ug) of folic acid daily to reduce their risk of having a pregnancy affected with spina bifida or other neural tube defects. Folic acid is a B vitamin. For women, this amount of folic acid on a daily basis spina bifida or anencephaly, both of which are neural tube defects (NTDs) in the baby. PHS suggested several approaches by which this level could be reached: Improved dietary habits Fortification of the U.S. food supply Daily use of folic acid supplements by women throughout their childbearing years.

FDA Action:

In keeping with the recommendations of PHS and the FDA Food Advisory Committee called to study these issues, the Food and Drug Administration is requiring that folic acid be added to specific flour, breads and other grains. These foods were chosen for fortification with folate because they are staple products for most of the U.S. population, and because they have a long history of being successful vehicles for improving nutrition to reduce the risk of classic nutrient deficiency diseases.

These fortified foods include most enriched breads, flours, corn meal, rice, noodles, macaroni and other grain products.

Under the terms of the new rule:

Fortification levels will range from 0.43 milligrams to 1.4 mg per pound of product. fortification of grain products at these levels will allow the daily intake from all sources to remain below the recommended upper limit of 1 mg per day. The amount of folic acid that will be consumed through foods fortified at these levels is considered safe for all population (age/gender) groups. Manufacturers will be allowed to make claims on the labels that the fortified products contain folic acid and that adequate intake of the nutrient may reduce the risk of neural tube defects.

FDA also emphasizes that adequate levels of folic acid, in the form of folate, can be obtained by eating natural sources such as: Leafy dark green vegetables Legumes (dried beans and peas) Citrus fruits and juices Most berries

In addition, women can assure adequate intake by taking dietary supplements containing folic acid. The new rule takes account of the finding in PHS' recommendation that total folate consumption should be kept under 1 mg per day. This is because higher intake may complicate the diagnosis of pernicious anemia, one form of vitamin B12 deficiency, which especially affects older people.

Neural Tube Defects:

Neural tube defects, including spina bifida and anencephaly, are a common birth defect. Approximately 2,500 infants are born each year in the U.S. with an NTD. About half this number are though to be related to inadequate folate intake by the mother. Other NTDs have different causes that are not well understood. Spina bifida is a condition in which the spinal cord is exposed. A majority of babies born with spina bifida grow to adulthood with varying degrees of disability, ranging to problems with bowel and bladder control, and paralysis. Many may require a series of operations and other treatments. In anencephaly, infants die shortly after birth because most or all of the brain is absent.

Since NTDs develop very early in pregnancy (18-30 days after conception), often before a woman knows she is pregnant, it is essential that adequate intake of folic acid be maintained throughout the childbearing years. Women who have had a prior NTD-affected pregnancy are at high risk of having a subsequent affected pregnancy. When these women are planning to become pregnant, they should consult their physicians for advice.

Pernicious Anemia & Recommended Daily Limit:

Because the effects of high intakes of folic acid are not well known, but do include complicating the diagnosis of vitamin B12 deficiency, care should be taken to keep total folate consumption under 1 mg per day, except under the supervision of a physician. About 10 to 20 percent of the elderly are diagnosed as having low vitamin B12 levels. The effects of folic acid at levels between 1 and 5 mg are not well known, but include complication the diagnosis of vitamin B12 deficiency. Among persons with pernicious anemia, one form of vitamin B12 deficiency, adverse effects have been reported with daily intakes of 5 mg folic acid and above. Because FDA has a mandate to set fortification levels that are safe for all population groups, lack of long term data makes it impossible to conclude that continuous intakes of 1 mg or more daily would be safe.

The FDA rule is designed to keep total folic acid intake under the 1 mg level.

History of Food Fortification:

Addition of iodine to salt was one of the earliest successful fortification programs. Iodine fortification was initiated in the U.S. in 1924 to prevent goiter, cretinism and other symptoms of severe iodine deficiency. In the early 1930s, vitamin D was first added to cow's milk to aid in absorption of calcium and phosphorus, preventing development of rickets.

In 1938, voluntary enrichment of flours and breads was initiated to prevent the development of deficiency diseases in the general population. Enrichments included thiamin for beriberi, niacin for pellagra, riboflavin essential for proper functioning of vitamin B6 and niacin, and iron for iron deficiency anemia. Mandatory requirements were effective in 1943.

There are various other fortification requirements to enhance the quality of food such as vitamin A added to low and nonfat cow's milk and certain other dairy products, and lysine added to certain corn products to enhance protein quality. The 1994 FDA Consumer magazine article reprinted below provides additional information on folic acid and neural tube defects.