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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
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