Marsha wrote, " Rather than just reading the summary,
I recommend that Lactnetters read the entire book. The FDA in the US and
Health Canada jointly commissioned this look at how new ingredients are
evaluated.
The committee may have many ties to the formula industry but that does not
mean we should ignore this whole report. "

Marsha is absolutely correct that Lactnetters should read the entire book and
not just the summary.  Her very astute criticism made me rethink my comments.
 So I am back to struggling with reading this book :)

So today I focused on the Committee's comments on probiotics.  My
understanding of their comments regarding probiotics is that this addition to infant
formula followed the Committee's recommended algorithm.  And lo and behold they
state, "Probiotics have a history of safe use in infant formulas in other
countries, and a review of the scientific literature showed no significant adverse
events linked to these ingredients."  Yet, just recently I have been reading
about a number of adverse events related to probiotics and infants. The book
mentions the GRAS notice written to Nestle on their probiotic bacterias for use
in infant formula.  I would highly recommend that breastfeeding advocates read
this GRAS notice No. GRN 000049 written to Nestle from the FDA.
http://vm.cfsan.fda.gov/~rdb/opa-g049.html

The FDA is giving Nestle a written response to their notice that Nestle
believes that their bacterial strains are GRAS. "Nestle considers the members of
its GRAS panel [Nestle's GRAS Panel] to be qualified by scientific training and
experience to evaluate the safety of substances added to food."  The FDA
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."

Thus Nestle's GRAS Panel declares these bacterial strains GRAS, and the FDA
determines that Nestle is right in declaring it GRAS.  And, if you think the
FDA is taking any legal responsibility for the safety of these ingredients added
to infant formula, think again.  They state, "As always, it is the continuing
responsibility of Nestle to ensure that food ingredients that the firm
markets are safe, and are otherwise in compliance with all applicable legal and
regulatory requirements."  Thus I must ask, is the FDA a  regulatory institution
or a rubber stamp committee for this industry?  And if the basis of your system
for addressing safety concerns is self-monitoring, no algorithm devised by
man will prevent a disaster from occurring.  Self-interest, profits will always
take priority over safety, when you have a system in which industry monitors
itself.

At one point the letter written by the FDA states that, "Nestle expects that
infant formula containing these microbial ingredients will help maintain, in
formula-fed infants, an intestinal flora composition resembling that in infants
fed human breast milk..."  Of course it will genetically resemble/imitate
human breast milk because Nestle did some borrowing--it took bifido strains from
the feces of a breastfed infant (patent # 5902743 and 5922375). We seem to be
talking about genetic manipulations--because Nestle is reassuring the FDA that
antibiotic resisistance is not expected to occurr in the S. thermophilus
strain Th4 to present an adverse public health risk. (but note they don't mention
the other strains).  Nestle states that these strains are not intended for use
with immunocompromised infants.  I would suggest that any infant whose sole
source of nutrients is from infant formula is immunocompromised but I imagine
that isn't what they mean.

If the basis for your system is flawed, will the system work?  The flaw here
is that you have a system that allows industry to monitor its own safety.
Nothing you do once you implement this kind of system, will eliminate this
essential flaw.  I find it interesting that the Committee find's Nestle's probiotics
GRAS a good example of the system working well and are critical of how Martek
got GRAS for DHA and AA.  Is this a reflection of the committee members and
their affiliations?
Valerie W. McClain, breastfeeding advocate

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