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From:
Janice Berry <[log in to unmask]>
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Lactation Information and Discussion <[log in to unmask]>
Date:
Sun, 1 Jun 2003 11:31:58 -0400
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Is it true that the FDA has received NO complaints?!
Janice Berry
Columbus, OH
***
The Marketing of a Superbaby Formula
By GREG RETSINAS

PARENTS who hire tutors to make sure their 3-year-olds can beat out the
competition for the best nursery schools are now being told that the
time to give their offspring an academic edge comes far, far earlier. 

New baby formulas supplemented with fatty acids are being promoted as a
way to bolster I.Q. and improve eyesight in infants. For formula
manufacturers, including Abbott Laboratories, Bristol-Myers Squibb and
Wyeth, the additives have become the latest weapon in the $3 billion
market in the United States, where competition has grown more intense as
mothers reject formula in favor of breast-feeding.

The problem, say some parents and doctors, is that the additives may not
do what the companies say they do, although their use could cost parents
an additional $200 a year for formula. The Food and Drug Administration,
which oversees the composition of formula, last year allowed inclusion
of the acids, after a five-year review. But the F.D.A. did not accept
the argument of formula makers that the additives provide great health
benefits, calling the results of studies "mixed." A major independent
study ordered by the F.D.A. will not be released until September, and
the American Academy of Pediatrics has not endorsed the new formulas
because of what it calls their "unknown adverse effects."

Nevertheless, many parents, persuaded by intense advertising campaigns,
are choosing to buy the new products.

Although infant formula contains a complex mixture of more than two
dozen vitamins and minerals, it is treated as a food product, not as a
drug, and its manufacturers decide what claims can be made on the label.

While makers of baby formula have long promoted the benefits of their
products, their marketing of the formula with the fatty acids DHA and
ARA is more aggressive, parents and pediatricians say. One magazine
advertisement suggests that a baby will develop "the mind of a
scientist" by drinking the formula. The label of another calls the acids
"important building blocks." Many hospitals are receiving free samples
of the new formulas, which are given to parents after their babies are
born. 
              
Summer Benoit, a 28-year-old new mother in Wyoming, Minn., chose to
switch to formula after breast-feeding her first child, Andrew, for two
months because she was returning to work. To her, the formula cans
looked vaguely alike and had similar names. She based her choice on the
fact that coupons in a magazine offered a $10 discount for Enfamil
Lipil, complete with a claim that it was the next-best thing to breast
milk.

"So, obviously, you hear that, and being a new mom, you want whatever
that is, and you try it," said Ms. Benoit, a customer service
representative for a water filter company near Minneapolis. She had to
switch to a different product, however, because Andrew didn't do well
with the formula with additives. 

The F.D.A. says it has not received any consumer complaints about the
new additives in formulas, which it added to its list of "generally
regarded as safe" ingredients, without commenting on their
effectiveness. But it has asked the makers of the new formulas to do
"rigorous post-market surveillance because there is no history of their
use in the U.S." The additives have been used in formulas sold abroad
since 1996.

Ross Products, the Abbott subsidiary that produces the Isomil and
Similac brands, and Mead Johnson Nutritionals, the Bristol-Myers
subsidiary that makes Enfamil, are the largest companies in the
business. Both have completed dozens of clinical trials that have showed
short-term benefits among infants who were fed formulas with the
additives. One of the longest studies tracked infants from birth to 39
months and found that the I.Q.'s of children who used the enhanced
formula were equivalent to those of children who were fed with breast
milk, which is widely considered to be the best nourishment for
newborns. They were not compared with infants who were fed formula not
enhanced with the fatty acids.

Studies have varied in their approaches. For example, research at the
University of Kansas, financed by the industry, found that infants who
had taken formula with the fatty acids looked at pictures of faces for
slightly shorter times than did infants who had not had the enhanced
formula. That suggested that the cognitive development of the first
group was more advanced, the researchers said.

A report last year by the American Council of Science and Health, a
consumer education group in New York, reviewed nearly two dozen studies
on the topic and found that about a third showed no difference in
infants who took the DHA-supplemented formulas versus those who did not,
while the other two-thirds showed benefits for the babies.

Some critics say the lack of long-term, independent studies is
significant.

The Institute of Medicine, a part of the National Academy of Science, a
nonprofit research organization that advises the federal government on
scientific matters, has been studying the additives for two years and is
expected to release its findings in the fall.

The F.D.A. requested the institute's study, and an F.D.A. spokeswoman
said that if any problems happened to emerge, the F.D.A. could use its
authority to recall the products. But because formula is regulated as a
food product, not as a drug, the F.D.A. does not control what claims the
manufacturers can make or whether the products live up to those
representations.

T'S unproven or uncertain that those ingredients provide an extra
benefit," said Dr. Cheston M. Berlin Jr., a pediatrician in Hershey,
Pa., and a member of the Institute of Medicine panel. "I wouldn't use
the word `misleading,' but they are certainly presented in a fashion
that if they don't do it, they aren't doing a favor for their kids," he
said of the advertising aimed at parents.

In a recent issue of American Baby magazine, for example, three
full-page color ads were devoted to the enhanced formulas. Each
product's ad suggested that a baby's brain development would improve
with the additives. The fine print for one product, Similac Advance, did
note that another Similac formula without the additives would also
support brain and eye development.

The two acids in the additives have long been linked to health benefits
beyond the world of babies. DHA, or docosahexaenoic acid, for example,
which is found in fish oil, is thought to help reduce the risk of heart
attacks, according to the DHA Information Center at Rockefeller
University in New York. ARA, arachidonic acid, also a fatty acid, is
found in meat, eggs and milk and is believed by some to improve brain
development.

After Mead Johnson, based in Evansville, Ind., rolled out Enfamil Lipil
last year, Ross Products, based in Columbus, Ohio, followed with Isomil
Advance and Similac Advance — products that contain the supplements but
in lesser amounts than in Enfamil. At the time, Ross officials said they
were not convinced of the scientific benefit but were introducing the
products to give customers more choice.

Now Ross is actively promoting the brands with the additives, especially
to pediatricians, whom the formula companies regard as pivotal in
reaching parents. "We have sales reps who try to convince them that
Similac Advance is a good thing to do," said Rock Marasco, vice
president of Ross Products.

Mr. Marasco, like other executives in the formula business, said his
company had no plans to stop making the nonadditive formulas because
many consumers might still be attached to those brands. 

Ross has about a third of the infant-formula market, second to Mead,
which has more than half. The other major players are the Swiss giant
Nestlé and Wyeth, based in Madison, N.J., which makes Wal-Mart's
Parent's Choice formulas as well as America's Store Brand, which is sold
at stores like Kmart and Target and wrapped in their own labels.
Parent's Choice also offers the additives with one of its brands. Nestlé
does not make a formula enhanced with DHA-ARA.

Dr. Berlin said parents who have received manufacturers' coupons and
brochures promoting the additive-enhanced formulas have asked him if
they are better. He tells them to buy cheaper nonadditive generic brands
because they provide just as much benefit.

The manufacturers justify the added cost by citing both past and current
clinical trials and the fact that only one company makes the forms of
DHA and ARA used in infant formula. 

Martek Biosciences, a biotechnology company in Columbia, Md., came up
with its DHA-ARA blend from algae and fungi. Last year, it acquired
OmegaTech, a Colorado concern that was also producing DHA and which had
financed the Kansas study.

Martek, whose DHA-ARA oils are used in formulas around the world, raised
$83 million in a stock offering in April, and its stock has doubled in
the last six months. It earned more than $28 million on the sale of
additives for infant formula in the United States last year, and plans
to add the nutritional supplements to other products, including those
marketed to pregnant women.

Henry Linsert Jr., Martek's chief executive, said global sales should
reach $100 million this year, half from companies in the United States. 

FORMULA makers would not discuss sales details, but all the companies
that have added products with the fatty acids have had increases in
overall sales. They have reached parents through hospitals, which often
include the product with free-sample packages that also contain
disposable diapers, discount coupons and magazines. The companies hope
that new parents will stick with their brand after trying it during
their babies' first days.

For the manufacturers, the advertising is a way to increase sales in a
market where competing products are hard to tell apart. Todd N. Lebor,
an analyst at Morningstar Inc. in Chicago, said: "It's like the Pampers
business or any of these demographic-based businesses that just sort of
grow with population. If you're not taking market share, you're probably
not growing."

Dr. Jennifer Thomas, a pediatrician in Racine, Wis., said that "new
parents are being reached in a very vulnerable time in their lives."

While Dr. Thomas says she advises parents that formula is not as good as
breast milk, many hospitals encourage the use of formula through their
gift bags. New parents at All Saints Medical Center — the largest
hospital in Racine, with about 1,800 deliveries annually — are given the
DHA-ARA brands of Enfamil and Similac, which are provided free by the
manufacturers.

Despite opposition from the American Academy of Pediatrics, most
hospitals accept the free formula, which they use in their own
nurseries. Some accept it on the assumption that parents will ask for
the premium brands anyway, having seen them in advertising.

Some hospitals resist taking free formula, but they are few. One is the
tiny South County Hospital in Wakefield, R.I., which spends about $200 a
month on formula and has stopped letting manufacturers provide goody
bags, posters and other marketing materials. 

About half the formula sold in the United States is bought through the
Women, Infants and Children program, a federal grant program that
operates in each state and provides food and nutrition counseling for
low-income mothers. In a few states, the programs accept DHA-ARA
formulas; parents can choose cheaper products in those states, but if
they start in hospitals with the DHA-ARA brands, they may be reluctant
to change. The WIC program in California allows only the DHA-ARA
formulas for premature infants.

Other states have chosen not to allow the new formulas through WIC,
citing the extra cost. In North Dakota, where the WIC program feeds
about 3,300 infants annually, administrators have decided to renew a
contract with Nestlé for its Carnation brand.

Colleen Pearce, the state's program director, said she had considered
the new formulas but decided that studies of them were "a mixed bag."

"If it really isn't that big of a deal in terms of providing a
beneficial effect for normal healthy infants, why would we want to go
that route and face the added cost?" she said. 

ROSS PRODUCTS, which has surveyed breast-feeding annually for nearly 50
years, found that nearly 70 percent of mothers initially breast-fed
their children in 2001, the highest rate to date. But that percentage is
cut in half by the time the baby reaches six months, when many parents
begin using formula. 

In Minnesota, Ms. Benoit breast-fed Andrew for his first two months
before switching to formula. But she said she remained confused over
whether she erred in taking her child off of the enhanced formula. Her
husband, Dustin, has been in Iraq with his Army Reserve unit since
February, leaving her to make the child-rearing decisions alone.

"When you have new mothers and people who really don't know anything
about formula, everybody hears it's the next-best thing," she said, "and
that's what we're going to buy." 

             ***********************************************

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