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Subject:
From:
"Valerie W, McClain" <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Mon, 7 Jun 2004 06:26:58 EDT
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Peg,
You wrote, "The article also said that the company did not achieve success
overnight that it had taken 'long years for the U.S. Food and Drug
Administration to recognize the additives as safe."

I  believe what the article states is true and I have written many times
about it on Lactnet.  Martek had Wyeth pursue the GRAS status of DHA and AA made
from microbial sources back in 1998 and they were refused by the FDA in early
1999.  They were refused because they were "particularly concerned about
toxicological effects that could derive from constituents of the source
microorganisms, which have no prior use as a source of food ingredients."
http://vm.cfsan.fda.gov/~rdb/opa-g007.html

These concerns arose because at that time the FDA also looked at independent
studies to determine GRAS.  The FDA no longer does this, it accepts the
studies done by the company petitiioning for GRAS status. Thus when Martek applied
for GRAS status a year or so ago, the only studies the FDA looked at and
accepted were the studies so kindly provided by Martek.  Martek studies show no
problems.

I ran across a patent "invented" by Susan E. Carlson and assigned to Abbott
Labs called "Methods of reducing the incidence of necrotizing enterocolitis."
This is about formulas containing DHA and AA to reduce the incidence of
necrotizing enterocolitis.  I guess the ironic thing about her patent is that acco
rding to a variety of news articles, she has been gathering data on infant
nutrition and cognitive development in infancy that convinced Ross and Mead Johnson
to add these compounds to their formulas.  While she may very well be
investing in something she believes in, how unbiased an expert wll she be?  She is
also a member of the ISRHML (International Society for Research in Human Milk
and Lactation).  How  will we ever come to a unbiased assessment of DHA and AA,
if all the major researchers have patents on these components.  These are the
experts we turn to and they have an investment in making sure that these
components are placed in formulas or used as supplements.

That the DHA and AA additives are being advertised heavily now during the Ad
Campaign on breastfeeding is not surprising.  What is surprising to me is that
no one seems to be questioning that the Ad Council is partly sponsored by the
infant formula industry.  No one sees this as a problem?  No one sees this as
a limiting factor in what could and should be done?  Someone mentioned on
this list that finally the 20/20 program got to the bottom of the problem.
Frankly, I think they are just looking at the "tip of the iceberg."
Valerie W. McClain, IBCLC

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