According to a recent research study published in JAMA on 3rd May, 2016, after evaluating the beneficial effects of the folic acid fortified foods, FDA is thinking about fortification of folic acid to the corn masa flour i.e., the staple diet of many Latin Americans to reduce the chances of birth defects.
The approval of fortification was granted by the FDA on April 14, 2016, in a press release, according to which voluntary addition of up to 0.7 milligrams of folic acid per pound of corn flour will lead to a marked reduction in the folic acid deficiency in pregnant women which is associated with neural tube defects in infants.
FDA beliefs that currently fortification of folic acid would be done to the food items such as cereals, infant formula and some medical foods to ensure that people get enough folic acids through diet easily. Moreover, FDA encourages the fortification to certain enriched grains and related products including breads, rolls, noodles and pasta.
Dr Susan Mayne, the Director of the FDA’s Center for Food Safety and Applied Nutrition, validated the strength of folic acid by saying, “Increased consumption of folic acid in enriched flour has been helpful in reducing the incidence of neural tube defects in the general population.”
In 2012, US leading healthcare organizations including the March of Dimes Foundation and the American Academy of Pediatrics, and many others submitted a ‘food additive petition’ to request the extension of voluntary fortification of folic acid to corn masa flour for ensuring increased folic acid intake by the US women whose staple diet includes products made of corn masa flour.
FDA announced in the press released that the permission to the addition of a food additive as asked by petitioners will only be granted after reviewing the information provided by them scientifically for ensuring human safety. It should be noted that in order to determine the safety profile of folic acid fortification to corn flour, evaluation by the help of different factors such as human dietary exposure, toxicological data, and the stability profile of the folic acid in corn masa flour ete was done by FDA.
The debate on fortifying cereal grain with folic acid first started back in 1993 at a series of subcommittee meetings held by the US Food and Drug Administration (FDA). When a research found women who consume 400 μg of folic acid daily reduce their baby’s chances of developing neural tube defects, the subcommittee considered the fortification of the vitamin B as a public health strategy, but the members were still cautious at the time.
“There was a lot of debate,” recalls James L Mills, MD, MS, a senior investigator at the National Institute of Child Health and Human Development. “[Fortification would] prevent hundreds of neural tube defects but expose 300 million people to folic acid… it was a very close vote.”
The exact mechanism of how folic acid acts against the formation of neural tube defects is not fully understood but it is believed since the specific vitamin B provides carbon for the synthesis of DNA, it may play a crucial role in the methylation process of DNA.
The first folic acid fortification in the US was regulated finally in 1996 and by 1998 food manufacturers were supposed to add 140 µg of folic acid in every 100 g of cereal grain. After a while folic acid was also added to infant formula, breakfast cereals, and even in medical foods for chronically ill people.
In 1999 following folic acid fortification it came to light that cases of spina bifida in infants had decreased by 31% and similarly cases of anencephaly had also decreased by 16%. Four years later the CDC reported the number of infants born with neural tube defects in the US had decreased from 4,000 to 3,000, which showed the fortification of food products had been a remarkable move.
“Many put [folic acid fortification] on the list of the most effective public health interventions,” said Krista Crider, PhD, a geneticist with the CDC’s National Center on Birth Defects and Developmental Disabilities.
Now folic acid fortification prevents neural tube defects in more than 1,300 babies every year and also saves $400 million to $600 million in child care, since right now the number of infants with spina bifida is very low according to CDC records.
Even though the situation is already pretty promising, according to the CDC and the March of Dimes experts, more work is needed on the issue to ensure all women of childbearing age consume proper amounts of folic acid by eating fortified foods or taking supplements. The fortification is especially important for Hispanic women, since they have a higher risk i.e., 21%, of giving birth to children with neural tube defects. It is believed Hispanic women have a gene called methylenetetrahydrofolate reductase (MTHFR) which reduces the rate of their intracellular folate metabolism. Additionally, Hispanic women are less likely to take supplements of folic acid and only 17% of them have been known to take 400 µg or more of folic acid daily.
Furthermore, the Hispanic diet is made up of foods cooked using unfortified corn masa flour e.g., tortillas, which do not have folic acids fortification. In 2012 a number of organizations such as the March of Dimes, American Academy of Pediatrics, National Council of La Raza, and Spina Bifida Association, petitioned FDA on the issue. They asked FDA to allow food producers to willingly fortify corn masa flour with folic acid. In February 2016, 40 members of Congress urged FDA to approve the request in a letter.
“The population with the highest risk hasn’t had the benefit of folic acid fortification,” said Edward McCabe, MD, and the chief medical officer of March of Dimes. “It [will] have a huge impact on the folic acid level in Hispanic women.”