Remarks by
David A. Kessler, M.D.
Commissioner of Food and Drugs
March of Dimes
January 12, 1994

Good afternoon.

I'm here today because we have a rare public health opportunity and a clear imperative.

There are few times when an individual can take a relatively simple action to reduce the risk of a very serious health problem--especially a very serious birth defect. But this is one of those times. And that is why I am here today.

We are sending an important message to women of child bearing potential: You can reduce the chances of giving birth to a baby with a neural tube defect if you consume 400 micrograms of folate daily.

This is what scientific studies have demonstrated. Now we must make sure that all women are educated about this and can act on it. This is not science meant to be sequestered in medical texts. It is important information that should reach women of childbearing potential of every class, of every color, in every household in this country.

That is a big task, but with a potentially great gain.

Let me say that I personally appreciate all of you coming here today because we do have an enormous responsibility to educate the public on this issue.

As a pediatrician, I have taken care of infants and children with neural tube defects. Make no mistake: they are very serious defects that compromise the lives of those who are affected. But now we truly have an opportunity to make inroads--to significantly reduce the number of pregnancies affected by neural tube defects in this country.

Today, what can a woman do to consume 400 micrograms of folic acid?

She has several options.

First, she can take a multi-vitamin containing 400 micrograms of folate.

Let me pause here to note that sometimes .4 mg is used instead of 400 micrograms. They are, of course, the same. On the new food label, 400 mgs -- .4 mgs -- of folate will be shown as 100 percent of the daily requirement for folate. Consumers can simply look for products containing 100% folate.

Let me also note that I'm using the word folate interchangeably with folic acid.

A second option for women is to eat a sufficient amount of foods rich in folate. Foods like citrus fruits and juices, dark green leafy vegetables, beans and other legumes, and whole grains.

Many foods are rich in folate. We have listed on this chart some of the foods with the highest folate content.

Whether a woman chooses to take a supplement or focus on eating foods rich in folate, it will take a consistent commitment to do what it takes to meet the daily target.

Third, she can do both.

Let me go over these options. [USING PROPS]

First, the multi-vitamin. Most over-the-counter multi- vitamins contain 400 micrograms of folate. One multi-vitamin a day will guarantee an adequate intake.

Second, a few breakfast cereals contain the full 400 micrograms of folate in one serving. The new food label will say that the product contains 100% of the daily folate requirement.

A third way is to eat a total of five servings--in any combination--of citrus fruit and juices, dark green leafy vegetables, and beans.

Other foods, besides fruit and vegetables, can also combine to provide a daily intake of 400 micrograms.

Let me emphasize that the scientific studies tell us that a woman must take in adequate levels of folates beginning before she becomes pregnant. The critical time is the periconception period--several months before and after conception. Many women don't realize that they are pregnant when the need for folate is most critical. That is why any woman who could become pregnant needs to make sure she is consuming 400 micrograms daily.

Together with the March of Dimes, I am urging every woman who could become pregnant to take a multi-vitamin, eat foods rich in folic acid, or both.

Which route a woman takes is her choice. All options are reasonable. The option she chooses will depend on she feels she can best ensure that she gets adequate folic acid every day.

Each approach has its advantages.

Taking a supplement containing 400 micrograms of folic acid each day guarantees that she will get an adequate intake. For some women, this will be the easiest way to meet the goal.

The dietary route provides a different advantage. The foods that are rich in folate -- fruits, vegetables, whole grains -- are foods that also contribute to the kind of overall good nutrition that we now know is important to a healthy pregnancy outcome. By increasing folate intake through careful dietary choices, a woman is going to be improving her nutrition generally.

The third option provides the assurance of an adequate intake of folate and also offers the advantage of a healthy diet.

The public education campaign being launched today by the March of Dimes is a very important effort to encourage women to increase their folate intake. The Public Health Service has issued a recommendation to that effect. A couple of weeks ago FDA approved a health claim for folic acid-containing supplements and we are permitting one for food rich in folic acid.

This activity is prompted by a number of studies that now make a persuasive case for an association between a folic acid intake and risk of neural tube defects.

Let me briefly summarize some of that research.

The early clinical trials involved women who had a previous pregnancy with a neural tube defect and were therefore at an increased risk for another affected pregnancy. Folic acid supplements were given to see if the recurrence rate could be reduced. The key study, published in 1991, was a well-conducted randomized clinical trial undertaken by the Medical Research Council in Britain. It showed a significant reduction in recurrence of NTDs among women who received high daily doses of folic acid before and during early pregnancy. This study was very important because for the first time it isolated the protective role of folic acid in preventing NTDs.

Questions remained, however. Would lower doses be effective? Could folic acid reduce the occurrence of NTDs among women who previously had not had an affected pregnancy? Was dietary folate effective?

Over the last couple of years additional research has provided some answers. Step by step these studies built the foundation for our current recommendation. Let me briefly describe some of that research.

About a year and a half ago -- in August of 1992 -- preliminary results of a Hungarian study were reported. They showed no occurrences of neural tube defects among women taking multi-vitamin preparations containing levels of folic acid significantly lower than those used in the previous study. And it provided support for the use of folic acid to prevent first time occurrence of NTDs.

About the same time, FDA received results of another important study. This was a case control study of women in Boston, Philadelphia and Toronto. It found a significant reduction in NTDs among women taking supplements; the most common dose of folic acid in the supplements was 400 micrograms. This study also had another important finding: among women not taking supplements, folate intake from diet alone was associated with a reduction in NTDs. Significantly, these dietary effects followed a dose-response pattern.

These studies are supported by our understanding of the well-recognized role that folate plays in cell division and growth.

The link between folate in the periconception period and neural tube defects has been established.

Folate intake will not eliminate all cases of NTDs; clearly other factors are sometimes also at work when this malformation occurs. That's an important point. We are NOT saying to women that you will eliminate the possibility of bearing an affected child if you consume adequate levels.

As more research is completed, we may be able to further refine our message to women. But today women should focus on consuming 400 micrograms of folate.

It seems like a fairly simple thing to do. But I recognize that not all women across this country will be able to meet the goal. The question that has arisen for FDA, then, is whether the food supply should be fortified so that more women will consume an adequate amount of folate.

FDA has proposed fortifying certain foods at specific levels and we are now reviewing the comments on that proposal. Believe me, this is not an easy issue. As a scientific and policy matter, it is one of the more difficult ones I have confronted in my term as Commissioner.

Before we fortify the food supply for 250 million Americans, we have to make sure we get it right.

Over the next several months we will be working hard to come up with a sound policy on fortification.

But whatever difference of scientific opinion exists with regard to fortification, whatever policy issues will need to be resolved in the future, they should not detract from the important message we are here to deliver today.

Women can take steps now...immediately...today...to reduce their risk of having a baby with a neural tube defect. That is the clear message for every women in this country who could become pregnant.

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(Hypertext updated by jch 1998-MAY-27)