By Terence Chea

When it comes to infant nutrition, experts say, nothing beats mother's milk. So for decades, the world's infant-formula makers have attempted to create blends that contain the nutritional benefits of breast milk.

But until recently formula lacked two key ingredients: docosahexaenoic acid and arachidonic acid, also known as DHA and ARA. The two fatty acids, which breast milk contains, are believed to play a key role in a baby's mental and visual development. Formula fortified with DHA and ARA began selling overseas several years ago, but it still isn't available in United States.

That's expected to change next month. The Food and Drug Administration last year approved the addition of DHA and ARA to infant formula. Two major formula makers, Mead Johnson Nutritionals and Ross Products, recently announced plans to begin selling infant formula fortified with DHA and ARA in the United States. Other formula makers are waiting for FDA approval to sell similar products.

Many companies tout the enriched formula as a major advancement in infant nutrition. They point to studies showing that babies fed formula fortified with DHA and ARA perform better on tests measuring mental development and vision than infants fed unsupplemented formula. They are trying to convince doctors and parents that the higher cost of enriched formula will give their children a lifelong advantage.

"It's probably the most significant advance in infant formula in the last 25 or 30 years," said James W. Hansen, Mead Johnson's medical director. "We believe this provides the best opportunity for babies to get a head start in their development."

But not all experts are sold on the benefits of adding the two nutrients to formula. Few scientists dispute the importance of DHA and ARA to an infant's development, but some say that babies themselves can make the two fatty acids if they get the right nutrients. They cite studies in which enriched formula showed little effect on an infant's development.

The enhanced formula's commercial success is critical to Martek Biosciences Corp., the Columbia company that makes nutritional oils that are the only source of DHA and ARA approved for infant formula in the United States. In recent weeks, the company's stock price increased sharply in anticipation of the U.S. launch of fortified formula.

Infant-formula makers call breast milk the "gold standard" of infant nutrition. Breast feeding provides all the nutrients an infant needs to grow properly. It helps prevent sickness and promotes mother-child bonding. Studies have found that breast-fed infants on average score higher on intelligence tests than bottle-fed babies.

"Breast feeding is the best feeding," said Barbara Levine, director of the human nutrition program at Rockefeller University in New York. "But the reality is that not all moms can breast-feed."

Demand for infant formula has given rise to a worldwide industry that generates $6 billion to $8 billion in annual sales. Mead Johnson and Ross Products sell about 80 percent of the formula used in the United States, which makes up about one-third of the worldwide market. Formula makers say their goal is to make their products as close to breast milk as possible. Over the past decade, more than 20 studies have looked at the effects of adding DHA and ARA to infant formula.

Several recent studies have found benefits. In 1998, researchers in Scotland discovered that 10-month-old babies fed supplemented formula showed better problem-solving skills than infants fed an unsupplemented formula. A 2000 study funded by the National Institutes of Health found that 18-month-old babies fed fortified formula scored seven points higher on a 100-point-scale test of mental development than babies fed an unfortified formula. Other studies found that infants who received the supplements had faster rates of visual development.

Based on such studies, the World Health Organization and other health groups have endorsed the addition of fatty acids to infant formula.

But other studies found no improvements in babies fed the enhanced formula.

While other nations approved the sale of fortified formula, the FDA was cautious about approving Martek's nutritional oils, which are made from laboratory-grown algae. In the 1980s, scientists experimented with adding fish oil to formula as a source of DHA. But those studies found that fish oil impaired mental development in some infants. So the agency wanted to make sure Martek's oils didn't have any harmful side effects.

Last May, the FDA granted Martek's oils "generally recognized as safe" status, which cleared the way for their sale in the United States. Martek has licensed its oil blend to several major infant-formula companies, which must apply individually to add the ingredients to their formulas.

Formula with Martek's oils is sold in more than 60 countries for infants born prematurely. For other infants, it is sold in more than 25 countries including Britain, China, Australia, and many countries in the Middle East and South America. Supplemented formula has sold well overseas, Martek officials say. In some markets, sales of the supplemented formula have surpassed sales of regular formula.

Mead Johnson, the Evansville, Ind., maker of Enfamil, says its new formula, Enfamil Lipil, is the biggest advance in infant formula since iron was added in the 1970s. Enfamil Lipil will go on sale next month. Mead Johnson, a division of Bristol-Myers Squibb Co., said it has studied the addition of DHA and ARA in its formula for more than 10 years.

"We're not trying to say moms should stop breast feeding and use this," said Pete Paradossi, a company spokesman. "But for moms who choose not to breast-feed or cannot breast-feed, no other formula will come closer to breast milk."

The new formula will cost 10 percent to 15 percent more than regular formula. The company will continue to sell its regular Enfamil brand. In Hong Kong, where the company launched supplemented formula a year ago, sales of fortified formula are now triple those of its regular formula, Paradossi said.

Mead Johnson says the major challenge in the U.S. market will be educating the public about the two nutrients. They say most Americans, including the medical community, know little about DHA and ARA compared with people in some other countries.

"These are not well-known nutrients to physicians, much less so to the public," Hansen said. "There's a scientific education process that needs to take place about the benefits they have to offer."

The company is working to convince health-care professionals of the benefits of its juiced-up formula. Rather than directly advertising to consumers, company representatives are speaking at medical conferences and visiting doctors' offices.

Ross Products, maker of the Similac brand, has also announced plans to sell formula that contains DHA and ARA, but the company is lukewarm about the benefits of the nutrients. The company, a Columbus, Ohio, division of Abbott Laboratories, plans to launch a version of its flagship product Similac With Iron that contains DHA and ARA later this year.

Yet Ross says its in-house studies show that Similac With Iron already offers the same nutritional benefits as breast milk because it provides the nutrients that infants need to make the fatty acids themselves. Ross spokeswoman Mary Beth Arensberg said the company is adding DHA and ARA because parents and doctors asked that it do so. The company maintains that other studies show that while the nutrients are safe, the benefits of adding them are disputed.

Martek is betting on major revenue growth from sales of nutritional oils. The company expects its fiscal 2002 revenue to be double its $19 million revenue in 2001.

Martek plans to introduce nutritional supplements with DHA and ARA for pregnant and lactating mothers this year. Henry Linsert Jr., Martek's chairman and chief executive, said those products could generate twice as much business as the nutritional oils for infant formula.

Washington Post January 24, 2002; Page E01