Replacing Mother—Imitating Human Breast Milk in the
Laboratory
Novel
Oils in Infant Formula and Organic Food: Safe
and Valuable Functional Food or Risky Marketing Gimmick?
http://cornucopia.org/DHA/DHA
_FullReport.pdf
This high-impact report will be presented this morning to
the U.S. Breastfeeding Committee in Arlington,
Virginia (including the FDA, CDC
and other influential federal regulators).
Embargoed until today the first electronic news coverage
happened this morning on NPR's marketplace:
http://marketplace.publicradio
.org/display/web/2008/01/25
/baby_formula
******************************
**************
Lab-MADE "IMITATION"
BREAST MILK PUTS INFANTS AT
RISK, STUDY SHOWS
A new study shows that
efforts to imitate human breast milk
in the laboratory
by fortifying infant formula with oils from algae and fungus are a
marketing gimmick that puts infants at risk. Study findings include:
1.
Serious risks in premarket safety tests ignored
2.
Infants seriously sickened by what some medical professionals describe as
the "diarrhea formula"
3.
Virulent and long-term diarrhea recognized as grave health risk to
infants
4.
Industry accused of misleading marketing/advertising—discourag
ing
breast-feeding
5.
Novel oils extracted with a toxic solvent that is banned in organic production, hexane
6.
Benefit to cognitive and visual development of infants is mixed at best
Contacts:
Charlotte
Vallaeys
, The Cornucopia
Institute: 978-369-6409
Marsha Walker, NABA: 781-893-3553
Mark Kastel
, The Cornucopia Institute: 608-625-2042
Infant Formula
Manufacturers Again under Ethical Cloud
;
"Marketing Gimmick" Linked to
Serious Illnesses
ARLINGTON, VIRGINIA:
A report released today by
The Cornucopia Institute presents research indicating that new additives placed
in infant formula are seriously endangering the health of some formula-fed
newborns and toddlers.
The report,
Replacing
Mother—Imitating Human Breast Milk in the Laboratory, details
research questioning the alleged benefits of adding "novel" omega-3
fatty acids, produced in laboratories and extracted from algae and fungus, into
infant formulas. The additives raised health and safety red flags during
preapproval testing while aggressive marketing campaigns by some infant formula
manufacturers appear to have encouraged new mothers to give up nursing for the
questionable infant products.
“When I worked in the hospital’s neonatal ward,
the nurses all called it ‘the diarrhea formula’,” says Sam
Heather Doak, LPN, IBCLC, from Marietta
,
Ohio.
“We’ve seen infants, tiny little humans, with diarrhea that just
wouldn’t stop after being given this formula.” For infants,
virulent and long-term diarrhea is considered a serious and life-threatening
medical episode.
The infant formula referenced by Doak was supplemented with
Martek Biosciences Corporation’s laboratory-produced oils containing DHA
and ARA. DHA, an omega-3 fatty acid, and ARA, an omega-6 fatty acid, are
naturally found in human breast milk and are considered important nutrients for
rapidly developing infants.
But laboratory-produced DHASCO and ARASCO (Martek’s
names for their proprietary oils) are materially different from the fats found
in a mother’s breast milk. Martek’s products are extracted from
fermented algae and fungus, with the use of the synthetic solvent hexane, a
neurotoxic chemical. They contain only 40 to 50% DHA and ARA, with the
balance being
sunflower oil,
diglycerides, and
nonsaponifiable materials. Some of these components are not found in human
breast milk, and the triglycerides carrying DHA and ARA are not identical to
those found in human breast milk—and have never been part of the diet for
human infants.
Infant formula manufacturers suggest that DHA and ARA oils
in formula are necessary to support proper development, yet serious doubts
persist within the scientific community regarding whether these oils actually
confer any long-term benefits to an infant’s brain and eye development.
“It’s true that DHA and ARA are important
nutrients for developing infants—that’s why they’re found in
human breast milk. But we have also seen that some infants are experiencing
side effects like diarrhea from consuming the manufactured DHA and ARA oils in
formula,” says Jimi Francis, Ph.D., a biochemist specializing in DHA in
infant nutrition at the Allie M. Lee Laboratory for Omega-3 Research at the
University of Nevada at Reno. Also, humans are able to produce DHA and ARA on
their own from other fats.
The Cornucopia Institute, a Wisconsin-based farm and food
policy research group and corporate watchdog, presented its report, in
partnership with the National Alliance for Breastfeeding Advocacy, to
government officials and medical professionals at the January 25th
meeting of the U.S. Breastfeeding Committee in Arlington, Virginia.
“While infant formula manufacturers claim that these
oils are perfectly safe and necessary for proper development, our report aims
to provide a more balanced and detailed picture,” said Charlotte
Vallaeys, Farm and Food Policy Analyst with the Cornucopia Institute and lead
author of the report. “We investigated how a toxic chemical is used as
processing agents in the manufacturing process, the inadequate testing for
safety, and most importantly, how some infants are experiencing serious adverse
reactions from consuming formula supplemented with these oils,” Vallaeys
added.
“This report presents a disturbing look at the
addition of novel ingredients into infant formula,” says Marsha Walker,
Executive Director of the National Alliance for Breastfeeding Advocacy.
“The FDA has received scores of reports on the adverse effects of these
ingredients, but, to date, the public's only access to these is through
Cornucopia's Freedom of Information Act request. This report will help alert
the health care community and federal agencies to some of the adverse
effects of added DHA and ARA in infant formulas.”
Cornucopia and the National Alliance for Breastfeeding Advocacy
also announced that they are calling for a warning label on all formula
containing DHA/ARA. The groups are petitioning the FDA for a label alerting
parents of the range of possible complications from DHA/ARA-supplemented
formula.
“Although many infants seem to be able to tolerate
these materials, regardless of their efficacy, we know that some children face
serious and even life-threatening impacts,” said Vallaeys.
“At a minimum parents need to be informed of the risks so they can
immediately pull children off these designer formulas if health complications
occur.”
While FDA officials had previously noted studies that
reported diarrhea, flatulence, jaundice, and apnea in infants fed
DHA/ARA-supplemented formula, they nevertheless did not block the use of the
oils. That action gave the green light for infant formula manufacturers to add
the oils to formula. Today, Martek boasts that 90% of formula in the U.S.
contains its patented DHA- and ARA-containing oils.
Advertisements touting DHA/ARA-supplemented formula as
“closer than ever to breast milk” have sparked another action from
Cornucopia and the National Alliance for Breastfeeding Advocacy. The two
groups have jointly filed a petition with the Federal Trade Commission alleging
that formula companies are engaged in misleading advertising. The ads appear
based on shaky scientific evidence.
“Adding these two fatty acids to formula does not make
it ‘close to breast milk,’” says Jennifer Thomas, M.D., a
pediatrician practicing in Racine,
Wisconsin. “Breast milk has
nutrients, live cells, and bioactive compounds that are absent from
formula,” she added. “These advertisements make it a lot harder for
me, as a pediatrician, to convince new mothers to breastfeed if they have seen
advertisements or labels implying that formula is just as good as breast milk.
The Cornucopia Institute is especially concerned that these
additives are now sold in certified organic formula, a practice that appears to
violate federal organic regulations. “This marketing gimmick has no place
in organics,” said Mark Kastel, Cornucopia's Codirector.
Federal regulations, Kastel explained, specifically prohibit
the use of hexane-extracted ingredients in organic foods. Cornucopia has filed
a Freedom of Information Request looking at how the USDA appears to have
collaborated with lobbyists for Dean Foods and others in secretly allowing
these materials.
The full report can be viewed on The Cornucopia
Institute’s web page at:
http://cornucopia.org/DHA/DHA
_FullReport.pdf
- 30 -
MORE:
Product Safety
Since
its introduction six years ago, the majority of formula
in the United States
is now supplemented with "novel" omega-3 and omega-6 fatty acids,
produced in laboratories, extracted from algae and fungus. Currently,
formula manufacturers do not provide any information, on labels or
their web sites, on the possibility of adverse reactions in some
infants.
The Cornucopia
Institute is urging parents of infants who have reacted negatively to formula with DHA and ARA to report
these adverse reactions to the FDA’s Safety Information
and Adverse Event Reporting Program.
Reports can be submitted online by
following this link: https://www.accessdata.fda.gov
/scripts/medwatch/medwatch
-online.htm.
The Cornucopia
Institute is collecting this data as well and is encouraging parents who feel
their children have been negatively impacted by formula
containing DHA/ARA, or health care
providers who suspect that the formula
has caused health problems, to send their reports
to the organization at
cultivate@cornucopia.org.
Organics
In 2006, a compliance officer at the USDA dismissed a formal legal complaint alleging that hexane-extracted
algal DHA and fungal ARA oils were illegally added to organic
infant formula. This
ruling, the latest in a series of industry-friendly interpretations of the organic standards, appears to be in conflict with
the law passed by Congress and in violation of the Organic Food Production Act
of 1990.
The National Organic Standards Board (NOSB) is charged by
Congress to recommend changes to the national organic
standards and the list of allowed materials/ingredients, with input from the
public. USDA officials must consult the NOSB in matters of this nature. This
dismissal of the complaint was considered by some to be equivalent to a green
light to formula manufacturers to
add a hexane-extracted, unapproved substance to organic
products.
The Cornucopia
Institute believes that such clandestine changes of the organic
rules, subsequent to secret negotiations with industry lobbyists, were illegal
and is presently researching avenues for
redress.
Hexane-extracted algal oils, known as
“Life’sDHA®,” have also made their way into organic milk and organic
nutrition bars. Dean Food’s Horizon
brand and Stremicks, for example,
now sell milk with hexane-extracted algal DHA oils.
All the organic
infant formula products and milk in
question are certified by the nation’s largest USDA accredited certifier,
Quality Assurance International (QAI).
“When I buy organic
milk, I expect to pay a little more
because I want safe and wholesome food without chemicals or
processed with toxic substances. I expect the government to respect and enforce the organic
rules, and it upsets me that they are allowing Horizon
milk to call itself ‘organic’
when it has these illegal, hexane-extracted ingredients,” says organic consumer Emily Ladow Reynolds, from Boston,
Massachusetts.
