After further searching in our phone book, I have found two businesses
with the name Solus here in Indianapolis, one of which Valerie
mentioned, Solus Industrial Innovations.  However, the address for both
of these businesses does not match the address on the letterhead of the
FDA letter (all are street addresses).  I also believe that the name
Solus Products, LLC must be the name of the company, since I have a
fledgling private practice LLC and I use the exact name of the business
as registered with the state. It is still possible it may be a
subsidiary of the company mentioned above.  The two, however, have
different physical addresses here, so it seems doubtful.  The mystery
deepens!

I also meant to point out the letter from the AAP which is on the FDA
website.  The AAP said some very meaningful and encouraging things which
I haven't heard mentioned here, though my LN browsings have been spotty
recently, rather like the showers this weekend!
1) On the issue of powdered formulas, they recommended:
-Microbiologic standards for all powdered infant formula because of the
E Sakazakii cases;
-Standards for powdered formula should be the same for preterm and term
babies, stating that they know of no reason this should not be the case
and noting that the absolute risk to term babies "is not zero".

2) They expressed concern over the GRAS status of Bifidobacterium and
Streptococcus being added to formula for infants over 4 months,
recommending that it not be added and noting that there is currently no
formula on the market which is specifically for infants over 4 months
allowing some unintended use by younger babies.  They stated that the
research is not in as to the safety of these products

3) They recommended that a growth study be required befor any future
changes to the formulation or packaging of formulas can be made.  They
cite the addition of the LCPUFA and state that, "Infant formula is
unique in that it can be the sole source of nutrition for an extended
period of time and at a most vulnerable time.  Growth alone as the sole
outcome measure may not be adequate.  As the changes in formulas become
more subtle, such as with the recent addition of (LC-PUFA), outcome
measures must also include other relevant effects such as those of
visual acuity and intelligence.  These effects may only become
measurable months to years after the infant is no longer taking
formula."

They further note that optimal growth may or may not be the crucial
outcome measure and that this has not even be adequately defined.  They
specify that future research on formulas be conducted over years not
months, which would necessitate post-market surveillance by the formula
companies.

All in all sounds pretty good to me!  This letter was dated August 28,
2003.  Anyone know if any these proposed changes have been given serious
review?

Full text of the letter at:
http://www.fda.gov/ohrms/dockets/dailys/03/Sept03/090503/090503.htm
Click on AAP

Marsha
~~~~~~~~~~~~~~~~~Marsha Glass RN, BSN, IBCLC~~~~~~~~~~~~~~~~~~~~~
Mothers have as powerful an influence over the welfare of future
generations as all other earthly causes combined.
~~~~~~~~~~~~~~~~~~~~~~~~~John S. C. Abbot~~~~~~~~~~~~~~~~~~~~~~~~~





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