Study on Effectiveness of EFAs in Infant Formulas Causes Controversy
Published: Saturday, September 01, 2001
A recent study of 404 infants, published in the August issue of Pediatrics and sponsored by the Ross Products Division of Abbott Laboratories (ABT), reports that there were no developmental benefits seen in infants fed formula enhanced with docosahexaenoic acid (DHA) and arachidonic acid (AA) —fatty acids found naturally in breast milk—compared to those fed normal formula or breast milk. The enhanced formulas contain substances that mimic naturally occurring DHA and AA and are claimed to have similar effects on the development of an infant.
The findings have sparked some controversy among those who claim that both acids, when added at high levels to formula, improve mental and visual development for infants.
Martek Biosciences Inc. (MATK), a primary producer of DHA and AA, which has GRAS (generally recognized as safe) status as determined by FDA for infant formulas, says the study does not accurately portray the benefits of DHA and AA because the dosages used were insufficient. “We feel the main issue [with the study] was the low levels used in the trial. The level used was below any recommendations by international health organizations and experts,” says Angela Tsetsis, director of marketing for Martek.
Mary Van Elswyk, Ph.D., R.D., VP of scientific affairs for Boulder, Colo.-based OmegaTech Inc., which also produces DHA [from micro algae], agrees. “The Pediatrics study supplied a very low dose: 0.14 percent of total fatty acids. Studies that have shown benefits supplied as much as 0.36 percent. It’s hard to hypothesize that it is a source issue. What we’re most likely seeing is an insufficient dose and improper balance,” she says.
Oddly, notes Van Elswyk, in the same issue of Pediatrics a study of preterm infants supplemented with the fatty acids found benefits.
She also says that it is important not only to study the effects of DHA and AA on infant development but to examine the benefits of maternal status. “There is no information or indication on how to determine a mother’s DHA level or the correlation between baby and mom,” she says, which is another reason studies measuring benefits in infants could be flawed. “In short, maternal DHA status during pregnancy is going to impact infant DHA status and subsequent ability to respond to DHA supplementation. A baby could have all it needs or 20 percent or 50 percent. If you throw all the babies into a study without considering the mother, you’re going to have a hard time interpreting results.”
OmegaTech is currently sponsoring a study with 100 babies at the University of Kansas Medical Center to compare infants, up to 18 months of age, for cognitive and visual outcomes using information about mothers who used DHA supplements and those who didn’t. The goal is to design more comprehensive trials in the future. “The big take-home message is that there has to be a better consensus for these term-infant studies. You have to be consistent with how to design the trials,” Van Elswyk says.
According to Van Elswyk, four studies have shown no benefit, while three others have found benefits. “They all differ in sample size, amount, and the form in which it was supplied, as well as the outcomes that were measured. To draw a conclusion from one study and say there is no benefit is reckless, in my opinion,” she says.
While the controversy lingers in the media, Martek is focusing on getting its product into infant formulas in the U.S., where current regulations don’t accommodate EFAs in infant formulas. Martek currently sells to companies in more than 60 countries worldwide. “The only way that Martek could affect the situation [approval of DHA] was to submit for GRAS with FDA,” she adds. Tsetsis also notes that the DHA market is relatively small.
The future for DHA is positive, according to Van Elswyk. “I think awareness is going to grow tremendously with the introduction of DHA to infant formula, which is imminent. With that, the awareness level is going to go through the roof—general awareness for the benefits for the brain and eyes particularly will allow the market to grow enormously,” she says. Van Elswyk notes that studies looking at the benefits for adults are likely in the near future.
Tsetsis concurs that education will be key to the growth of DHA and AA. “Once that happens, there will be other opportunities besides infant formulas, because people will be educated and confident about the use of DHA in diet.”