Organic Infant Formula Ingredients Processed with Toxic Chemical
FDA Reports Indicate Infants Sickened from Algae/Fungal-Based
Nutritional Supplements
CORNUCOPIA, WI. -- The Cornucopia Institute
filed a legal complaint with the US Department of Agriculture
(USDA) today, demanding that the agency enforce the organic
regulations prohibiting toxic solvents from being used in the
production of organic food. The Institute, a nonprofit food
and farm policy research group, found that baby formula and
other food manufacturers are using hexane-extracted omega-3
and omega-6 fatty acids (DHA/ARA) derived from algae and soil
fungus.
Perhaps more startling,
through a Freedom of Information request at the FDA, Cornucopia
found algal- and fungal-based DHA/ARA have been linked to serious
side effects such as virulent diarrhea and vomiting in infants
consuming infant formula, many of whom required medical treatment
and hospitalization.
“The federal organic
regulations very clearly prohibit these oils in organic foods,
so this is not a case of companies finding loopholes in the
regulations. What we’re seeing is the latest in a long
string of USDA actions that blatantly cater to industry interests
at the expense of consumer safety,” said Mark Kastel,
Codirector of the Cornucopia Institute, based in Cornucopia,
Wisconsin. “USDA officials are simply allowing these companies
to freely break the organic rules in their pursuit of profit,”
he adds.
Organic products with the
prohibited fatty acid supplements include Horizon Organic milk
with DHA and organic infant formulas, including Similac Organic,
Earth’s Best, and Bright Beginnings Organic.
Martek Biosciences Corporation
produces these DHA and ARA supplements. They are extracted from
fermented algae and soil fungus with the use of a highly explosive
neurotoxic petrochemical solvent, hexane. The Occupational Safety
and Health Administration lists hexane as a serious hazard to
worker health and safety, and the Environmental Protection Agency
classifies it as a hazardous air pollutant. The National Organic
Program strictly prohibits its use in the processing of organic
foods and ingredients.
“Only a change in
the regulations would make these oils legal in rganic foods,
and a regulation change requires citizen input,” said
David Cox, a lawyer with the Columbus, Ohio law firm of Lane,
Alton, and Horst. “USDA officials do not have the legal
authority to decide on their own that they will not enforce
the regulations, no matter how much industry is lobbying or
pressuring them.”
The addition of DHA and
ARA to organic infant formula is especially troublesome considering
that Martek’s oils are linked to serious illness in some
infants. “Through a FOIA request, we discovered that scores
of parents have notified the FDA that their infants experienced
symptoms such as serious cases of diarrhea, vomiting, and extreme
gassiness from consuming DHA/ARA formula, often requiring medical
intervention. These symptoms commonly disappeared as soon as
the infants were given regular formula without these supplements,”
said Charlotte Vallaeys, the author of Cornucopia’s comprehensive
report Replacing Mother—Imitating Human Breast Milk in
the Laboratory (www.cornucopia.org).
While formula makers claim
to add these oils because they “support brain and eye
development,” scientific data to corroborate these claims
are very weak. “Results of most of the well conducted
clinical trials have not shown beneficial effects of DHA and
ARA supplementation of formula milk on the physical, visual
and neurodevelopmental outcomes of infants born at term,”
according to Dr. Karen Simmer, professor in the School of Women’s
and Infant’s Health at the University of Western Australia.
Breast-feeding advocates
worldwide contend that DHA and ARA appear to be added primarily
as marketing tools. DHA and ARA supplementation adds approximately
$200 annually to the cost of formula, which is absorbed by parents
and publicly funded nutrition programs. Misleading claims that
DHA/ARA supplemented formula is now “as close as ever
to breast milk” also lead to the impression among many
new mothers that formula is now equivalent to breastfeeding,
which may contribute to lower rates of breastfeeding and higher
formula sales.
“Adding these two
fatty acids to formula does not make it ‘close to breast
milk,’” said 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. “Formula advertisements featuring DHA and ARA
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.”
But the serious side effects
experienced by some babies remain the most pressing reason for
keeping these oils out of organic infant formula. Cornucopia
has filed a Freedom of Information request to look into how
the USDA appears to have collaborated with lobbyists for Dean
Foods and others in secretly allowing these materials, despite
their explicit prohibition in the federal organic regulations.
“It's bad enough these materials are being added to conventional
infant formula,” said Cornucopia’s Kastel. “This
marketing gimmick has no place in organics, where mothers are
looking for the safest, most nutritious and natural foods for
their families.”
The Cornucopia Institute,
together with the National Alliance for Breastfeeding Advocacy,
has petitioned the FDA to require a warning label on all infant
formula supplemented with Martek’s DHA and ARA. Currently,
parents of infants who experience adverse reactions to DHA/ARA
formula have no way of knowing that these fatty acid supplements
may be the cause.
Few parents know that Martek’s
supplements contain only 40 to 50% DHA and ARA, with the balance
being sunflower oil, diglycerides, and “nonsaponifiable”
materials. Many 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. It is unclear why some infants
cannot tolerate these laboratory-produced DHA/ARA supplements.
But the evidence of side effects strongly suggests that more
research is warranted.
People
can urge the FDA to require a warning label by following the
attached link and posting a comment: http://www.regulations.gov/search/search_results.
The Cornucopia Institute
and the National Alliance for Breastfeeding Advocacy have also
petitioned the Federal Trade Commission (FTC), alleging that
formula companies are engaged in misleading advertising. The
ads touting benefits to brain and eye development appear to
be based on shaky scientific evidence. Lawyers at the FTC had
previously warned Martek and formula companies about overstating
the benefits of DHA and ARA. In response to the petition by
Cornucopia and NABA, the FTC is currently investigating the
alleged false advertisements.
Parents
and health care providers are encouraged to pass on reports
of adverse reactions to infant formula or food products containing
DHA and/or ARA to the FDA and to The Cornucopia Institute: cultivate@cornucopia.org
Also
today, The Cornucopia Institute filed a formal legal complaint
with the USDA, calling for an investigation of Quality Assurance
International (QAI). QAI is the nation’s largest corporate
organic certifier and has been at the center of a number of
other scandals in the organic industry, most prominently the
questionable certification of large factory farm milk production.
Cornucopia charges QAI with lax oversight and improper certification
of products containing DHA/ARA oils, including questioning whether
or not QAI is complying with the law and has the technical qualifications
to carry out their responsibilities.
The full formal complaints
can be viewed at:
www.cornucopia.org/DHA/USDA_DHA_LegalComplaint.pdf