Becky,  DHA has not been given GRAS status and has yet to be put in infant
formula in the USA.  However it is in formula marketed in Europe and Asia.
Press releases from Martek on this situation have been rather interesting and
I might add a little deceptive.(considered forward-looking statements) The
FDA at this point in time has notified Martek that they have no further
questions in regard to the approval process.  You may read the letter from
the FDA at Martek's web site  http://www.martekbio.com

Pay particular attention to the conclusions in this letter.  The letter
states, "The agency has not however, made its own determination regarding the
GRAS status of the subject use of ARASCO [AA ] and DHASCO [DHA]."  And even
more interesting if you read further on, the FDA sounds rather annoyed that
Martek has not been willing to set up a meeting with the FDA to discuss the
broad scientific issues raised by the GRAS notice.  They also go on to state
that the possibility exits that Martek may get GRAS approval but the infant
formula companies may have to go through the process of GRASS approval of DHA
themselves.

If you read the patents on Martek's DHA, you will realize that this oil is
genetically engineered.  In fact, the reason approval is taking so long has
everything to do with this fact. (Wyeth initially tried to get DHA approval
and was refused in 1997)  The FDA's statement that it wants to discuss the
"broad scientific issues" says it all.  That this oil is being used in
preterm and term infant formula in other countries is pretty scary to me.
Seems to me to be a major experiment on babies who are more at risk for
significant health effects than adults.

By the way the infant formula industry is working on genetically engineering
many of the components that are in human milk. (the many, many patents on
human milk components).  So eventually we will have an amazing chemical soup.
 If the FDA continues to accept genetic engineering as equivalent to the real
thing, we might even have infant formula companies claiming equivalence to
human milk.
Valerie W. McClain, IBCLC

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