- The Washington Times - Sunday, August 18, 2002

The baby-products aisle at the neighborhood grocery store features an array of choices as confusing as the one at the cosmetics counter.

For mothers who choose to give their babies infant formula, there are products with iron and without, made with soy, pre-mixed and pre-measured, brand names and generic.

The latest entries into the formula market are products enriched with a combination of two omega-3 fatty acids in an effort to enhance the neurological and visual development of children who are not breast-fed.

The U.S. Food and Drug Administration last year approved the addition of docosahexaenoic acid (DHA) and arachidonic acid (ARA) to formulas sold in this country. Those nutrients are found naturally in fish, and breast-feeding mothers who eat fish pass them to their infants. Adding these nutrients to formula is the latest innovation aimed at narrowing the gap between formula and mother's milk.

It is a gap many say will never completely close. The American Academy of Pediatrics (AAP), among other groups, recommends that mothers breast-feed babies for 12 months. Breast milk contains the right amounts of nutrients needed to foster growth and development, as well as 160 fatty acids not found in formula. Breast milk also contains specific immunological protection that, so far, formula manufacturers have been unable to replicate.

However, the AAP and government groups know that formula is an important substitute for breast-feeding. While 60 percent of American newborns are breast-fed at birth, just 21 percent are exclusively breast-fed by six months, the AAP reports. That has created a $3 billion formula industry in this country.

Enriched formulas can be big moneymakers, too. The products cost 10 percent to 20 percent more than traditional formulas, which already are pricey at about $10 to $12 a can (about a five-day supply for a 6-month-old). Pre-mixed formula and hypoallergenic mixtures can be even more costly.

"We do recognize that breast-feeding is the gold standard," says Pete Paradossi, spokesman for Mead Johnson Nutritionals, the company that manufactures Enfamil formulas, including Enfamil LIPIL, its new DHA- and ARA-enriched product. "But we realize that not every mom can breast-feed for the full duration. We want mothers to be confident and comfortable if they need formula. Formula has always been a good way to feed infants, and science continues to make it better."

Formula has evolved greatly since it was first commercially produced in the late 1800s. Generally, formula sold today is a mixture of cow's milk, whey, casein and fats, combined with dozens of nutrients required by the FDA. Among them are calcium, protein, folic acid and vitamins A, D, E and K.

Aside from different formulations for allergic or lactose-intolerant infants, not much had changed lately in the formula market until the addition of DHA and ARA.

Scientific studies show that enhanced formula may be a big boost to formula-fed babies, particularly those born prematurely.

"DHA is absolutely a good thing," says Norman Salem, a National Institutes of Health biochemist who has done research on DHA. "My view is it should be a requirement [for all formulas]. All babies and all people need sources of fish acids like DHA."

One NIH-sponsored study, conducted in 2000 by the Retina Foundation in Dallas, showed that babies who were fed a formula combining DHA and ARA scored higher on intelligence tests than other formula-fed babies. The study followed 56 18-month-olds who had received formula including DHA and ARA combined, formula with only DHA or formula that did not contain either substance. All the children were enrolled in the study within five days of their birth and received one type of formula for 17 weeks.

When their motor skills and intelligence were tested at 18 months, the children fed with DHA and ARA scored an average of seven points higher. They also scored higher on a visual acuity test.

Researchers at the Retina Foundation plan to follow up by studying larger numbers of children and by testing the current children in four years to see if their gains in intelligence persist into early childhood.

A study conducted at Dundee University in Scotland and published in the British medical journal the Lancet in 1998 said infants given enriched formula had superior problem-solving ability at 10 months compared with babies who drank unenriched formula. The study followed 72 children, half of whom drank the enriched formula from birth to 4 months. When tested at 10 months, both groups were able to solve simple mental problems, but the groups given enriched formula scored better on more complex problems.

Another study by Retina Foundation researchers, which was published in the Journal of Pediatric Gastroenterology and Nutrition in 2000, reported that infants who drank enriched formulas had DHA and ARA blood fatty-acid profiles similar to breast-fed babies.

However, a study of 239 babies, half of whom drank the enriched formula, found negligible developmental differences in babies fed different types of formulas. The study, published in the journal Pediatrics last year, was sponsored in part by Ross Laboratories, the Ohio-based manufacturer of Similac formulas. Nonetheless, Ross entered the DHA- and ARA-enhanced market with Similac Advance earlier this year.

Similac Advance, which contains DHA and ARA, was introduced partly in response to customer demand, says Mary Beth Arensberg, a Ross spokeswoman.

"Similac Advance offers parents and health care professionals a choice in feeding," Ms. Arensberg says. "Similac Advance builds on the benefits of Similac With Iron, which has been clinically shown to provide greater calcium absorption and greater bone density than other formulas. Both Similac Advance and Similac With Iron support brain and visual development like that of the breast-fed infant."

Preemies to benefit

Dr. Frank R. Greer, professor of pediatrics and nutritional sciences at the University of Wisconsin and a member of the AAP's Committee on Nutrition, says enriched formulas may help some babies. However, more research needs to be done on the long-term benefits, he says.

"The evidence on the effects for full-term babies is not totally convincing," Dr. Greer says. "The differences in IQ and vision scores are negligible. Premature babies are the ones who can most benefit because they don't get the fatty acid stores that cross the placenta. The FDA has recently approved it for preemies, though, and they can get the most benefit, as they clearly are at risk for neurological problems."

Dr. Greer, whose committee has no official stand on enriched formulas, says he would like to see more research on babies who started out breast-feeding, then switched to enriched formulas. He also says mothers who would be sold on raising a baby's IQ by a few points probably are going to be the type of mothers who breast-feed anyway.

"Formula is clearly expensive," he says. "It is definitely a moneymaker. Formula companies have tremendous marketing programs going on to teach physicians about the enriched formulas, but breast milk remains the feeding of choice, and the availability of these formulas does not change that."

Mardi Mountford, executive director of the International Formula Council, an Atlanta-based trade organization, also says the research shows mixed results.

"The manufacturers are constantly working to improve formula and make it more like human milk," Ms. Mountford says. "The addition of DHA and ARA is an innovation, but the scientific literature isn't clear as to its value, so the benefit is open to debate. Also, there may be subtle differences in ingredients."

Mr. Paradossi says enriched formulas end up costing about 25 cents more a serving than traditional formulas.

"We stand firmly committed to science," he says. "Our perspective is that if it is not shown to be clinically significant, then consumers should save their money. But as an innovation and breakthrough, we think the addition of DHA and ARA is significant."

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