FDA GRAS Notice to Nestle states:
 "Based on the information provided by Nestle, as well as other
information
available to FDA , the agency has no questions at this time  regarding
Nestle's
conclusion that B. lactis strain Bb12 and S.  thermophilus strain Th4 are GRAS
for their intended use as ingredients in  milk-based infant formula that is
intended for consumption by infants four  months and older at levels not to
exceed good manufacturing  practice."

I just felt the need to add some more comments to this quote from the GRAS
notice on probiotics from the FDA to Nestle.  Note that the FDA states based on
information from Nestle , and other information they consider the items GRAS.
But if you look at the references in this letter from the FDA, all the
references are by authors associated with Nestle or from the Nestle Research Center.
 So my question is what other references did the FDA look at?  When Martek
oils (through Wyeth) was initially refused GRAS by the FDA under the old rules,
they referenced the letter to studies not done by the manufacturer.  So if
they looked at other studies not done by Nestle, I would assume that should be in
the reference list.  Nothing there but Nestle research.

I also want to clarify that the comments I made about the IOM book on the
evaluation of infant formula.  The comments were my first read impressions.  It
seemed to me by some of the comments that the Committee made that they were
more sympathetic to Nestle than Martek.  But I do want to clarify that the
Committee was critical of both GRAS processes regarding probiotics and the
long-chain fatty acids.

Judy's comments regarding the 4 month or 6 month feeding issue were
interesting to me because I overlooked this totally.  That is why it is so vital that
many breastfeeding advocates look at these books or documents because no one
person can see the whole picture.
Valerie W. McClain

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