2010 Dietary Guidelines Advisory Committee Written Comments

February 26, 2010

Carole Davis
Co-Executive Secretary of the Dietary Guidelines Advisory Committee
Center for Nutrition Policy and Promotion
U.S. Department of Agriculture
3101 Park Center Drive, Room 1034
Alexandria, VA 22302

RE: 2010 Dietary Guidelines Advisory Committee Written Comments

Dear Ms. Davis:

The Spina Bifida Association (SBA) appreciates the opportunity to provide comments to the U.S. Department of Agriculture (USDA) and the U.S. Department of Health and Human Services’ (HHS) Dietary Guidelines Advisory Committee, as the Dietary Guidelines for Americans are reviewed and revised. We commend the USDA, HHS, and the Committee for their efforts to update the guidelines and ensure that the American people have authoritative advice on how proper dietary habits can promote health and reduce risk for major chronic diseases. The nation's dietary guidelines, the Food and Drug Administration’s (FDA) fortification requirements, and the Centers for Disease Prevention and Control’s (CDC) public health education and awareness initiatives all are essential and complementary tools in the effort to prevent Spina Bifida, the nation's most common, permanently disabling birth defect.

The SBA serves adults and children who live with the challenges of Spina Bifida. Since 1973, SBA has been the only national voluntary health agency solely dedicated to enhancing the lives of those with Spina Bifida and those whose lives are touched by this challenging birth defect. Through education, advocacy, research, and service, SBA provides hope and support to an estimated 166,000 people affected by all forms of this disabling birth defect. One of the SBA’s most vital functions is to raise awareness, through education and outreach, of the importance of daily folic acid intake in reducing the risk of neural tube birth defects, such as Spina Bifida. Formation of the neural tube begins in the first days of pregnancy, often before a woman even knows she is pregnant. Therefore, it is vital that women have sufficient folic acid intake prior to conception. We are proud that the SBA also serves as the official administrative agent for the National Council on Folic Acid; in this role we lead the collaborative effort between national health organizations, federal agencies, and industry stakeholders to educate the 65 million women of childbearing age about the importance of folic acid intake.

Overview of Major Recommendations

As you undertake the development of the 2010 guidelines, we urge you to retain the “key recommendation for specific population groups" relating to folic acid consumption. Since approximately half of all pregnancies in the United States are unplanned and there is strong scientific evidence that women must have adequate folic acid intake prior to becoming pregnant, we strongly recommend you modify the wording of the recommendation to apply to all women of childbearing age, irrespective of plans to become pregnant. The SBA maintains that it is essential that all women of childbearing age regularly consume adequate daily amounts of folic acid through a variety of folic acid fortified food products, food folate from a varied diet, and multi-vitamins, which can significantly reduce the risk of a Spina Bifida affected pregnancy. To that end, we specifically recommend the following changes to the current folic acid recommendation (strikethroughs are recommended deletions and words in bold are suggested additions):

Women of childbearing age who may become pregnant and those in the first trimester of pregnancy. Consume adequate synthetic folic acid daily (from fortified foods or supplements, such as a daily vitamin) in addition to food forms of folate from a varied diet.

Moreover, to help advance public education and awareness among all women of childbearing age, we respectfully urge you to incorporate and highlight messages about the importance of folic acid consumption into the press release and other collateral materials associated with the dissemination of the new guidelines.

 

Folic Acid Fortification of U.S. Food Supply

The risk of Spina Bifida and other serious birth defects can be reduced by up to 70%, if women of childbearing age consume 400 mcg of folic acid (a B-vitamin) every day. Folic acid is a B-vitamin that helps build healthy cells. During periods of rapid growth, such as pregnancy and fetal development, the body's requirement for this vitamin increases. Since Spina Bifida occurs early in pregnancy, often before a woman knows she is pregnant, it is important that women consume adequate amounts of folic acid every day, even if not actively attempting to become pregnant, especially given the statistic that almost half of all pregnancies are unplanned.

As you know, beginning in 1996, the FDA issued a requirement that folic acid be added to specific flour, breads, and other grains. These foods were chosen for “fortification" with folic acid, because they were staple products for most of the U.S. population. In January 1998, the FDA added a requirement that folic acid be added to food products that use enriched flour. These fortified foods include most enriched breads, flours, corn meals, rice, noodles, macaroni, and other grain products. Since 1992, the U.S. Public Health Service and the CDC have recommended that women, who could become pregnant, consume 400 mcg of folic acid every day – either through a daily multi-vitamin, fortified foods, foods naturally containing folic acid, or some combination of both.

We are pleased that, today, most over-the-counter multi-vitamins contain an adequate daily dose of folic acid. However, we are concerned that from 1999 through 2004, there was an 8% to 16% decline in the level of the vitamin folate in the blood of U.S. women of childbearing age, according to a study published in the January 5, 2007 issue of the CDC Morbidity and Mortality Weekly Report.¹ Studies have shown that only one-third of U.S. women of childbearing age consume the daily recommended amount of folic acid. Therefore, as noted above, we believe that it is imperative for the 2010 Dietary Guidelines to recommend that all women of childbearing age consume 400 mcg of folic acid daily from a variety of folic acid fortified food products, food folate from a varied diet, and multi-vitamins.

Health Disparities Tied to Foods Not Currently Required to be Fortified

Whole-grain breads are not under the current FDA mandate, because they already naturally contain some folate. In addition, corn flours (also referred to as corn masa flours) are not under the FDA mandate, as they do not have a Standard of Identity (SOI) established by the FDA; this means that corn flours have not been defined by the FDA as a grain product requiring folic acid fortification.

While corn meal products manufactured in the United States are subject to the FDA fortification requirements, corn meal products manufactured in – and imported from – other countries (e.g., imported tortillas) often are not fortified. Given that corn flours and many imported corn products serve as a staple in the diets of many Hispanic Americans, the CDC believes that this deficiency contributes to the disproportionate rate of Spina Bifida among Hispanic women in the United States. Research indicates that a Hispanic woman in the U.S. is 1.5 to 2 times more likely to deliver a baby with neural tube defects than a non-Hispanic White woman.²

A 2009 CDC analysis suggests fortification would effectively target Mexican American women, without substantially increasing folic acid intake among other populations. In addition, in 2009, the CDC released a preliminary analysis, estimating that additional fortification of corn masa flour will result in a 0.1 percent decrease in the birth prevalence of folic acid-preventable Spina Bifida and anencephaly among Hispanics.

To address this inconsistency, which poses a risk to public health for certain communities, the SBA and its sister organization, the Spina Bifida Foundation, and the National Council on Folic Acid, have been exploring ways to encourage companies that make imported corn meal products to begin fortifying their products to meet the FDA standard. In the interim, to help address the neural tube defect health disparity seen among the Hispanic population, the SBA urges that the 2010 Dietary Guidelines include a specific message for Hispanic women as a “specific population group" to be addressed within the broader “Women and Folic Acid" recommendation.

Federal Recognition of this Public Health Challenge

The SBA is pleased that the FY 2011 CDC "Justification of Estimate for Appropriations Committee," identified activities to support promotion of preconception care, noting, “despite the 26 percent reduction in Spina Bifida and anencephaly that has occurred since fortification of the cereal grain supply with folic acid in 1998, Hispanic Americans continue to have a higher prevalence of neural tube defects (NTDs)." To address this disparity, the CDC stated (in its FY 2011 budget justification):

• "By September 2011, the CDC will issue recommendations on corn masa flour fortification and/or the concentration of folic acid in wheat flour fortification.
• The CDC will expand a targeted health education program to promote folic acid consumption in predominantly Hispanic communities to encourage preconception folic acid supplementation among Hispanic women of childbearing age."

The SBA appreciates the CDC’s work on this important issue, and urges coordination between the CDC, USDA, FDA, and the Dietary Guidelines Advisory Committee to ensure that all federal agencies involved in public health, nutrition, and dietary guidelines are doing their part to boost consumption of folic acid among women of childbearing age, especially among those communities disproportionately at risk.

Conclusion

It has been more than ten years since the FDA issued regulations requiring folic acid fortification of certain foods, and there is evidence that this enrichment has helped reduce Spina Bifida and other neural tube defects by approximately 26%. However, despite this tremendous public health win, too many women of childbearing age – particularly those in the Hispanic American community – still do not consume adequate amounts of folic acid. Given the evidence that folic acid fortification of corn products could reduce, annually by 0.1 percent, the number of pregnancies affected by Spina Bifida and other neural tube defects, greater incidence reductions could be seen especially in the Hispanic community. To that end, we strongly urge the Dietary Guidelines Advisory Committee to:

1. apply the folic acid recommendation to all women of childbearing age;
2. specifically address Hispanic women within the broader folic acid recommendation;
3. recommend that all corn, corn masa flour, and corn-based products available in the United States be enriched with folic acid; and
4. ensure that press releases and other collateral materials and on-line information highlight the folic acid recommendation for women of childbearing age.

We very much appreciate your attention to our recommendations regarding folic acid fortification and the need to increase awareness among all women of childbearing age of the need to consume adequate daily amounts of folic acid prior to becoming pregnant. The SBA stands ready to work with you and your colleagues to ensure that all women of childbearing age have the information they need – prior to becoming pregnant – to reduce and prevent the risk of a Spina Bifida pregnancy.

Thank you again for allowing us the opportunity to provide these comments. Should you have any questions, or if we can be of any assistance, please do not hesitate to contact me (202/944-3285, ext. 14, cbrownstein@sbaa.org).

Sincerely,

Cindy Brownstein
Chief Executive Officer
Spina Bifida Association