I don't know where Jane Brody gets her information but my understanding of
the GRAS notice at the FDA is that the FDA has no further questions at this
time and that the agency has not made its own determination regarding the
GRAS status of ARASCO [AA oil] and DHASCO [DHA oil].    DHA and AA oils are
genetically engineered.   Valerie W. McClain, IBCLC

The letter written to Martek is dated May 17, 2001 and may be viewed at
http://www.cfsan.fda.gov/~rdb/opa-g041.html

part of the letter states

"On January 29, 2001, at Martek's request, Martek met with representatives of
the Center for Food Safety and Applied Nutrition (CFSAN). In a letter dated
January 31, 2001, you reiterated a concern that you expressed on January 29
about a delay in the agency's response to your GRAS notice. In your January
31 letter, you outlined your understanding of a commitment made by CFSAN at
the January 29 meeting to define, as soon as possible, any specific
unresolved scientific questions related to this notice.
In a letter dated March 1, 2001, CFSAN explained that the delay in its
response to your GRAS notice was related to broader issues than those related
to your notice and described specific scientific concerns related to the use
of infant formulas containing long chain polyunsaturated fatty acids
(LCPUFAs) such as the fatty acids ARA and DHA. As we explained in our March 1
letter, some publications and panel reports, which considered multiple
sources of ARA and DHA (e.g, sources such as fish oil and egg phospholipid),
have questioned the scientific adequacy of data to support the use of LCPUFAs
in infant formula. In addition, some studies have reported unexpected deaths
among infants who consumed formula supplemented with LCPUFAs. These
unexpected deaths were attributed to Sudden Infant Death Syndrome (SIDS),
sepsis or necrotizing enterocolitis. Also, some studies have reported adverse
events and other morbidities including diarrhea, flatulence, jaundice, and
apnea in infants fed LCPUFAs. In addition, CFSAN noted that your notice had
not accounted for the fact that the bioactive fatty acids ARA and DHA when
consumed in mature human milk are part of a complex matrix that includes, for
example, linoleic acid, alpha-linolenic acid, and other polyunsaturated fatty
acids and that important physiologic considerations relative to the matrix
are not accounted for by the simple addition of LCPUFAs to infant formula.
In our letter dated March 1, 2001, we informed you that CFSAN intended to
convene a group of experts to address the broader scientific issues raised by
your specific determination that the ingredients DHASCO and ARASCO are GRAS
sources of DHA and ARA for use in infant formula.
In a letter dated March 23, 2001, Martek expressed its view that the reports
and publications that questioned the scientific adequacy of data to support
the use of LCPUFAs in infant formula recommended additional studies, which
are now available. Martek also noted that studies conducted in term and
preterm infants with balanced addition of ARASCO and DHASCO as sources of
both bioactive fatty acids showed no difference in deaths between treatment
and control groups. In Martek's view, the results of clinical studies
conducted with infant formulas manufactured by three different firms are the
most direct and conclusive evidence that there are no concerns related to
physiologic considerations associated with the overall physiological matrix
of infant formula compared to human milk.
In its March 23 letter, Martek expressed its view that some of the concerns
described in CFSAN's March 1 letter are hypothetical and that convening a
group of scientific experts to answer such hypothetical concerns would not be
productive."

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