Jan asked, "if anyone has any articles on how supplementing a breastfed baby
with either Lipil or Advance can impact that baby's gut?"
I have not seen any articles. I believe we can only speculate at this point,
since safety seems to be based on rat studies. When Wyeth applied for GRAS
status for DHA (DHASCO) and AA (ARASCO) in the late 90's, the FDA refused
GRAS status for these additives.
http://vm.cfsan.fda.gov/~rdb/opa-g007.html
"In FDA's view, multiple studies, including three of the published studies
(which your notice identifies as references 51, 97, and 108) that you rely on
to establish the safety of ARASCO and DHASCO, show treatment related effects
that raise questions about the safety of ARASCO and DHASCO. In particular,
these studies consistently show treatment related effects on the liver (mean
relative liver weight and liver function tests), mean relative spleen weight,
and hematological parameters in rats who consume ARASCO or a blend of
ARASCO/DHASCO compared to rats who consume a high-fat control diet. In
addition, in one unpublished study that is not included in your notice, oil
droplets are reported in the mesenteric lymph nodes and the intestinal villi,
and lipogranulomas are reported in the mesenteric lymph nodes in treated rats
who consumed ARASCO/DHASCO, or high-dose level of ARASCO alone. In its
evaluation of another unpublished 90-day study that is not described in your
notice, FDA considered that a no observed effect level (NOEL) in the rat for
combined exposure to ARASCO and DHASCO is 1100 mg/kg bw/day, based on
increased mean relative liver weights, changes in liver function tests, mean
relative spleen weights, and changes in hematological parameters of the mid-
and high-dose ARASCO/DHASCO treated females and males. Given this NOEL, the
estimated dietary intake by infants who would consume infant formula that
contains the blend of ARASCO and DHASCO at your "target level" is 8- to
20-fold less than the NOEL seen in the rat, on a weight basis. At the maximum
levels of use, this difference between the NOEL in the rat and the estimated
dietary intake by infants is 5- to 14-fold.
In FDA's view, these effects in rats raise concerns because of the potential
that such effects would occur in human infants. The authors of all three
published studies that you rely on (i.e., your references 51, 97, and 108)
have dismissed these effects without sufficient explanation. Likewise, your
notice provides no explanation for why the effects observed in published
studies in rats are not toxicologically significant in that species.
Importantly, your notice provides no explanation for why such effects in rats
are not of concern in human infants, particularly in preterm and young
infants."
And the FDA goes on to say, "We believe that these observations merit
consideration particularly because the sources of ARASCO & DHASCO have no
prior use in food."
Yet, in February of this year, Mead Johnson was given FDA approval for use of
these fatty acids in infant formula. (Winnie, all infant formula companies
must notify the FDA when a substantial change is made in the formulation of
their infant formula--because of the 1980 Infant Formula Act) I am not sure
that further studies were done that exonerate these substances but rather the
process of GRAS has substantially changed. Industries present their studies
and reasons for considering a food item safe. If the FDA has no questions,
the item is given GRAS status. Prior to this, the FDA spent considerable
time looking at not only the studies a company presented but indepedent
studies to determine GRAS. So in the interest of time, approval is put on a
fast track. Who benefits from this fast track method of approval? Not the
consumer.
It is estimated that somewhere between 50-75% of all USA foods are
genetically engineered--mostly corn and soy crops. I have read that many of
our vitamins and supplements are also genetically modified. I recently read
that 80% of the vitamin C supplements are gmo'd. Do we believe that the
infant formula industry is keeping this out of their infant formulas? If 1/2
to 3/4's of our food system is contaminated with genetically modified
organisms, how can we believe that infant formulas have escaped
contamination? Around the world, various countries with the help of
Greenpeace have documented the contamination of soy formulas by gmo. A hear
few protests in the USA in regard to our infant formula being gmo'd. One
might assume that consumers don't care. I frankly think that most Americans
just don't know or just don't understand what genetic engineering means.
The major problem with any food that is genetically modified is that we don't
know all the possible ramifications of this new technology. We can make
assumptions but we don't know. We do know that genetically engineered
products have the potential to be toxic. For example the supplement
L-trptophan killed some 37 people and permenantly disabled or hurt some 5,000
people. Bacteria from the recombinant process contaminated the supplement.
Dr. Arpad Pusztai's research showed that genetically engineered potatoes
damaged the vital organs and immune systmes of lab rats fed those potatoes.
Interestingly enough Pusztai lost his job--he was fired after he talked to
the media about this. Information that is unsupportive of genetic
modification is often suppressed and scientists whose studies show that it is
unsafe find themselves on the unemployment lines.
Infant formula, whether genetically engineered or not, has always been an
experiment on our most vulnerable population. The problem now is that this
new food technology is creating novel foods. Humans have never eaten this
kind of "food" before and consequently we have thrown out any sense of due
precaution in regard to such experimentation.
Are some of the ramifications of this new technology already in evidence?
There is an interesting patent called "Heteropolysaccaride produced by
Enterobacter Sakazakii." Filed in 1985 by Harris et al. and assigned to Dow
Chemical. This heteropolysaccaride is used as a food additive or a gelling
agent for detergents and sanitizers. It is also used in irrigation and
drinking water as a frictional drag reduction agent. (used in spray drift
control for herbicides and pesticides of food crops). It is a "novel" strain
of bacteria intially fermented from tea. Is this novel strain contaminating
infant formula? The infant formula industry has had problems with this
bacteria since the late 80's. Has this bacteria gotten more virulent because
of genetic modification? Many questions and many important industries that
seemingly don't want to look too closely at this new food technology because
it would impact their enormous investment in this technology. Valerie W.
McClain, IBCLC
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