There has been some discussion on this list about DHA and whether it is GRAS
(Generally Recognized As Safe) by the FDA.  DHA was given GRAS status.
The history of DHA getting this approval is rather interesting.

Wyeth initially sought GRAS status for DHA and AA.  They were refused. see
http://vm.cfsan.fda.gov/~rdb/opa-g007.html

At that time the rules for GRAS approval were different than they are now.
The new rules are a notification procedure not an affirmation process!!  Thus,
GRAS status is simply the industry stating that they believe their substance
is GRAS.  Approval or rejection is based on research provided by the industry
not independent research.  It has made the process much quicker.  Thus items
that were approved prior to this "notification" program underwent a more
rigorous process.

http://www.cfsan.fda.gov/~lrd/fr970417.html

"FDA is also proposing to replace the current GRAS affirmation process with a
notification procedure whereby any person may notify FDA of a determination
that a particular use of a substance is GRAS. Under the proposed notification
procedure, the agency intends to evaluate whether the submitted notice provides
a sufficient basis for a GRAS determination and whether information in the
notice or otherwise available to FDA raises issues that lead the agency to
question whether use of the substance is GRAS. This proposal reflects FDA's
commitment to achieving the goals for the Reinventing Food Regulations part of the
President's National Performance Review(herein after referred to as Reinventing
Food Regulations). The proposed notification procedure would allow FDA to
direct its resources to questions about GRAS status that are a priority with
respect to public health protection."

An interesting commentary about US rules on genetically modificed organisms
and in particular "pharming" is well worth reading.  (The splicing of the human
gene for lactoferrin and rice in California would be called pharming. Cloned
cow's milk is pharming and is GRAS).  It is written by Claire Hope Cummings,
who was a lawyer for the USDA during the Carter Administration.  She traces the
history of the deregulation of the biotech industry.  She also states at one
point in her commentary that:

"any 'novel' substances in food must be tested and perhaps labeled.  However,
if something can be 'generally regarded as safe' (GRAS), as most conventional
foods are, then they are exempt.  Since GMOs are 'substantially equivalent'
to conventional food, they are considered GRAS and thus they do not require
testing or labels."
http://www.twnside.org.sg/title/service57.htm

GRAS is no longer an approval process.  It is a notification procedure.  One
could say that the FDA has absolved themselves of responsibility to monitor
the food industry.  The responsibility has fallen to the industry itself.  The
FDA views foods made through biotechnology as functional equivalent to the real
thing.  Therefore, we are introducing many novel ingredients into our
population, without rigorous, unbiased research to its safety.  The concern of course
should be in the case of infant formula, for the health and well-being of
infants, a more vulnerable population.  There are some experts such as Dr. Vyvyan
Howard of the University of Liverpool who mentions in the UK Daily Mail of
March 1999 that experiments have raised questions of the possibility that GM
foods migh harm the immune systems and internal organs of infants and babies.
Valerie W. McClain, IBCLC

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